Pulmonary Disease, Chronic ObstructivePhase 4NCT00523991
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
A Phase 4 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 62 sites in 10 countries.
Trial summary
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 62 sitesin 10 countries
- Study dates
- Apr 2007to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:
- post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).
- Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
- Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.
Who cannot join
- Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
- Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
- Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Trial locations and contacts
62 sites in 10 countries.
62 sites in 10 countries
United States17 sites
205.365.1010 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
205.365.1012 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
205.365.1003 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.365.1004 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.365.1086 Boehringer Ingelheim Investigational Site
Bloomington, Minnesota
205.365.1080 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
205.365.1118 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.365.1122 Boehringer Ingelheim Investigational Site
Clarksburg, West Virginia
205.365.1098 Boehringer Ingelheim Investigational Site
Jasper, Alabama
205.365.1092 Boehringer Ingelheim Investigational Site
Kingsport, Tennessee
205.365.1024 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
205.365.1085 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
205.365.1023 Boehringer Ingelheim Investigational Site
Palo Alto, California
205.365.1033 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
205.365.1006 Boehringer Ingelheim Investigational Site
Rochester, Minnesota
205.365.1007 Boehringer Ingelheim Investigational Site
Rochester, New York
205.365.1125 Boehringer Ingelheim Investigational Site
San Diego, California
Czechia12 sites
205.365.1064 Boehringer Ingelheim Investigational Site
Cvikov
205.365.1107 Boehringer Ingelheim Investigational Site
Hradec Králové
205.365.1061 Boehringer Ingelheim Investigational Site
Karlovy Vary
205.365.1077 Boehringer Ingelheim Investigational Site
Liberec
205.365.1079 Boehringer Ingelheim Investigational Site
Neratovice
205.365.1116 Boehringer Ingelheim Investigational Site
Pardubice
205.365.1062 Boehringer Ingelheim Investigational Site
Prague
205.365.1083 Boehringer Ingelheim Investigational Site
Prague
205.365.1117 Boehringer Ingelheim Investigational Site
Prague
205.365.1075 Boehringer Ingelheim Investigational Site
Strakonice
205.365.1063 Boehringer Ingelheim Investigational Site
Tábor
205.365.1076 Boehringer Ingelheim Investigational Site
Ústí nad Labem
Ukraine7 sites
205.365.1128 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
205.365.1108 Boehringer Ingelheim Investigational Site
Kharkiv
205.365.1110 Boehringer Ingelheim Investigational Site
Kharkiv
205.365.1112 Boehringer Ingelheim Investigational Site
Kharkiv
205.365.1114 Boehringer Ingelheim Investigational Site
Kiev
205.365.1115 Boehringer Ingelheim Investigational Site
Kiev
205.365.1113 Boehringer Ingelheim Investigational Site
Simferopol
Germany5 sites
205.365.1055 Boehringer Ingelheim Investigational Site
Berlin
205.365.1066 Boehringer Ingelheim Investigational Site
Berlin
205.365.1054 Boehringer Ingelheim Investigational Site
Gelnhausen
205.365.1052 Boehringer Ingelheim Investigational Site
Rüdersdorf
205.365.1050 Boehringer Ingelheim Investigational Site
Ulm
Belgium4 sites
205.365.1103 Boehringer Ingelheim Investigational Site
Gilly
205.365.1059 Boehringer Ingelheim Investigational Site
Leuven
205.365.1057 Boehringer Ingelheim Investigational Site
Menen
205.365.1058 Boehringer Ingelheim Investigational Site
Yvoir
Canada4 sites
205.365.1056 Boehringer Ingelheim Investigational Site
Kingston, Ontario
205.365.1041 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
205.365.1104 Boehringer Ingelheim Investigational Site
Toronto, Ontario
205.365.1042 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
Netherlands4 sites
205.365.1070 Boehringer Ingelheim Investigational Site
Enschede
205.365.1072 Boehringer Ingelheim Investigational Site
Etten-Leur
205.365.1071 Boehringer Ingelheim Investigational Site
Spijkenisse
205.365.1069 Boehringer Ingelheim Investigational Site
Zutphen
Greece3 sites
205.365.1067 Boehringer Ingelheim Investigational Site
Athens
205.365.1127 Boehringer Ingelheim Investigational Site
Athens
205.365.1126 Boehringer Ingelheim Investigational Site
Thessaloniki
Portugal3 sites
205.365.1025 Boehringer Ingelheim Investigational Site
Amadora
205.365.1020 Boehringer Ingelheim Investigational Site
Coimbra
205.365.1022 Boehringer Ingelheim Investigational Site
Lisbon
United Kingdom3 sites
205.365.44002 Boehringer Ingelheim Investigational Site
Garston, Watford
205.365.44003 Boehringer Ingelheim Investigational Site
Harrow
205.365.44004 Boehringer Ingelheim Investigational Site
Warminster
About this study
Official title: A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropiumDrug
Oral inhalation once daily of 18mcg tiotropium via handihaler
PlaceboDrug
Oral inhalation once daily of placebo matching tiotropium via handihaler
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Oral inhalation once daily of placebo matching tiotropium via handihaler Receives: Drug: Placebo |
| tiotropium | Experimental | Oral inhalation once daily of 18mcg tiotropium via handihaler Receives: Drug: tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Change = Week 24 Value - Baseline Value
Measured: baseline, week 24
Secondary outcomes (136)
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: Baseline
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: Baseline, week 8
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: Baseline, week 16
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: Baseline, week 24
Peak Forced Expiratory Volume in 1 Second (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Measured: Baseline
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: Baseline, week 8
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: Baseline, week 16
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: Baseline, week 24
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Forced expiratory volume in 1 second (baseline, pre-dose)
Measured: Baseline
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Forced expiratory volume in 1 second (baseline, 30 minutes)
Measured: baseline, 30 minutes
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Forced expiratory volume in 1 second (baseline, 60 minutes)
Measured: baseline, 60 minutes
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Forced expiratory volume in 1 second (baseline, 120 minutes)
Measured: Baseline, 120 minutes
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Forced expiratory volume in 1 second (baseline, 180 minutes)
Measured: Baseline, 180 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)
Measured: baseline, week 8, pre-dose
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)
Measured: Baseline, week 8, 30 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)
Measured: baseline, week 8, 60 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)
Measured: baseline, week 8, 120 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)
Measured: baseline, week 8, 180 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)
Measured: baseline, week 16, pre-dose
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)
Measured: Baseline, week 16, 30 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)
Measured: baseline, week 16, 60 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)
Measured: baseline, week 16, 120 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)
Measured: baseline, week 16, 180 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)
Measured: baseline, week 24, pre-dose
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)
Measured: baseline, week 24, 30 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)
Measured: baseline, week 24, 60 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)
Measured: baseline, week 24, 120 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)
Measured: baseline, week 24, 180 minutes
FVC AUC0-3 at Baseline
Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
Measured: baseline
FVC AUC0-3 at Week 8 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)
Measured: baseline, week 8
FVC AUC0-3 at Week 16 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)
Measured: baseline, week 16
FVC AUC0-3 at Week 24 Minus Baseline
Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)
Measured: baseline, week 24
Trough Forced Vital Capacity (Baseline)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: baseline
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: baseline, week 8
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: baseline, week 16
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.
Measured: baseline, week 24
Peak Forced Vital Capacity (FVC) (Baseline)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.
Measured: baseline
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: baseline, week 8
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: baseline, week 16
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.
Measured: baseline, week 24
Forced Vital Capacity (Baseline, Pre-dose)
Forced vital capacity (baseline, pre-dose)
Measured: baseline
Forced Vital Capacity (Baseline, 30 Minutes)
Forced vital capacity (baseline, 30 minutes)
Measured: baseline, 30 minutes
Forced Vital Capacity (Baseline, 60 Minutes)
Forced vital capacity (baseline, 60 minutes)
Measured: baseline, 60 minutes
Forced Vital Capacity (Baseline, 120 Minutes)
Forced vital capacity (baseline, 120 minutes)
Measured: baseline, 120 minutes
Forced Vital Capacity (Baseline, 180 Minutes)
Forced vital capacity (baseline, 180 minutes)
Measured: baseline, 180 minutes
Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)
Change from baseline in forced vital capacity (week 8, pre-dose)
Measured: baseline, week 8, pre-dose
Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)
Change from baseline in forced vital capacity (week 8, 30 minutes)
Measured: baseline, week 8, 30 minutes
Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)
Change from baseline in forced vital capacity (week 8, 60 minutes)
Measured: baseline, week 8, 60 minutes
Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)
Change from baseline in forced vital capacity (week 8, 120 minutes)
Measured: baseline, week 8, 120 minutes
Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)
Change from baseline in forced vital capacity (week 8, 180 minutes)
Measured: baseline, week 8, 180 minutes
Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)
Change from baseline in forced vital capacity (week 16, pre-dose)
Measured: baseline, week 16, pre-dose
Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)
Change from baseline in forced vital capacity (week 16, 30 minutes)
Measured: baseline, week 16, 30 minutes
Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)
Change from baseline in forced vital capacity (week 16, 60 minutes)
Measured: baseline, week 16, 60 minutes
Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)
Change from baseline in forced vital capacity (week 16, 120 minutes)
Measured: baseline, week 16, 120 minutes
Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)
Change from baseline in forced vital capacity (week 16, 180 minutes)
Measured: baseline, week 16, 180 minutes
Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)
Change from baseline in forced vital capacity (week 24, pre-dose)
Measured: baseline, week 24, pre-dose
Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)
Change from baseline in forced vital capacity (week 24, 30 minutes)
Measured: baseline, week 24, 30 minutes
Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)
Change from baseline in forced vital capacity (week 24, 60 minutes)
Measured: baseline, week 24, 60 minutes
Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)
Change from baseline in forced vital capacity (week 24, 120 minutes)
Measured: baseline, week 24, 120 minutes
Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)
Change from baseline in forced vital capacity (week 24, 180 minutes)
Measured: baseline, week 24, 180 minutes
Albuterol Use p.r.n. (Baseline)
Number of days that participants used albuterol prn per week
Measured: baseline
Change From Baseline in Albuterol Use p.r.n. - (Week 4)
Difference in number of days that participants used albuterol prn per week between week 4 and baseline
Measured: baseline, week 4
Change From Baseline in Albuterol Use p.r.n. - (Week 8)
Difference in number of days that participants used albuterol prn per week between week 8 and baseline
Measured: baseline, week 8
Change From Baseline in Albuterol Use p.r.n. -(Week 12)
Difference in number of days that participants used albuterol prn per week between week 12 and baseline
Measured: baseline, week 12
Change From Baseline in Albuterol Use p.r.n. - (Week 16)
Difference in number of days that participants used albuterol prn per week between week 16 and baseline
Measured: baseline, week 16
Change From Baseline in Albuterol Use p.r.n. -(Week 20)
Difference in number of days that participants used albuterol prn per week between week 20 and baseline
Measured: baseline, week 20
Change From Baseline in Albuterol Use p.r.n. - (Week 24)
Difference in number of days that participants used albuterol prn per week between week 24 and baseline
Measured: baseline, week 24
Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: baseline
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: week 12
Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)
The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: week 24
Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: baseline
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: week 12
Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)
The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.
Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.
Measured: week 24
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Measured: baseline
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Measured: baseline, week 4
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Measured: baseline, week 8
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Measured: baseline, week 12
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Measured: baseline, week 16
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Measured: baseline, week 20
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Measured: baseline, week 24
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Measured: baseline
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Measured: baseline, week 4
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Measured: baseline, week 8
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Measured: baseline, week 12
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Measured: baseline, week 16
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Measured: baseline, week 20
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Measured: baseline, week 24
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Measured: baseline
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Measured: baseline, week 4
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Measured: baseline, week 8
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Measured: baseline, week 12
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Measured: baseline, week 16
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Measured: baseline, week 20
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Measured: baseline, week 24
Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.
Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.
Measured: baseline
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.
Measured: baseline, week 4
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.
Measured: baseline, week 8
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.
Measured: baseline, week 12
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.
Measured: baseline, week 16
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.
Measured: baseline, week 20
Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)
WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.
Measured: baseline, week 24
Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents.
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm.
Measured: baseline
Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 4
Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 8
Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity defined as less than three metabolic equivalents.
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 12
Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 16
Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 20
Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Light intensity is less than three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 24
Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 4
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 8
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 12
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 16
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 20
Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day
Moderate or higher intensity is greater than or equal to three metabolic equivalents
Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.
ln in measure value unit means natural logarithm
Measured: baseline, week 24
Number of Participants With Healthy Lifestyle (Baseline)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: baseline
Number of Participants With Healthy Lifestyle (Week 4)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 4
Number of Participants With Healthy Lifestyle (Week 8)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 8
Number of Participants With Healthy Lifestyle (Week 12)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 12
Number of Participants With Healthy Lifestyle (Week 16)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 16
Number of Participants With Healthy Lifestyle (Week 20)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 20
Number of Participants With Healthy Lifestyle (Week 24)
Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no
Measured: week 24
Active Energy Expenditure (Baseline)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline
Change From Baseline in Active Energy Expenditure (Week 4)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 4
Change From Baseline in Active Energy Expenditure (Week 8)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 8
Change From Baseline in Active Energy Expenditure (Week 12)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 12
Change From Baseline in Active Energy Expenditure (Week 16)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 16
Change From Baseline in Active Energy Expenditure (Week 20)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 20
Change From Baseline in Active Energy Expenditure (Week 24)
The amount of energy (kcal/day) that a person uses while physically active.
Measured: baseline, week 24
Number of Steps Per Day (Baseline)
Number of steps per day (baseline)
Measured: baseline
Change From Baseline in Number of Steps Per Day (Week 4)
Change from baseline in number of steps per day (week 4)
Measured: baseline, week 4
Change From Baseline in Number of Steps Per Day(Week 8)
Change from baseline in number of steps per day (week 8)
Measured: baseline, week 8
Change From Baseline in Number of Steps Per Day (Week 12)
Change from baseline in Number of steps per day (week 12)
Measured: baseline, week 12
Change From Baseline in Number of Steps Per Day (Week 16)
Change from baseline in number of steps per day (week 16)
Measured: baseline, week 16
Change From Baseline in Number of Steps Per Day (Week 20)
Change from baseline in number of steps per day (week 20)
Measured: baseline, week 20
Change From Baseline in Number of Steps Per Day (Week 24)
Change from baseline in number of steps per day (week 24)
Measured: baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523991
- Sponsor's protocol ID
- 205.365
- Other IDs
- A4471008, 2006-006276-38
- Status last verified
- May 2014
- First submitted
- 9 Jul 2007
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.
PubMed 24841833
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00523991
- Acronym / sponsor ID
- 205.365
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Apr 2007
- Primary completion
- Jul 2010 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 29 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboOral inhalation once daily of placebo matching tiotropium via handihaler |
| tiotropium | Experimental | Drug: tiotropiumOral inhalation once daily of 18mcg tiotropium via handihaler |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:
- post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).
- Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.
- Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.
Key exclusion criteria (3 listed)
- Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.
- Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.
- Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tiotropiumOral inhalation once daily of 18mcg tiotropium via handihaler | Drug | tiotropium |
| PlaceboOral inhalation once daily of placebo matching tiotropium via handihaler | Drug | placebo |
Primary outcome
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)
Time frame: baseline, week 24
Change = Week 24 Value - Baseline Value
136 secondary outcomes
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)
Time frame: Baseline
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)
Time frame: Baseline, week 8
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)
Time frame: Baseline, week 16
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)
Time frame: Baseline, week 24
Peak Forced Expiratory Volume in 1 Second (Baseline)
Time frame: Baseline
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)
Time frame: Baseline, week 8
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)
Time frame: Baseline, week 16
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)
Time frame: Baseline, week 24
Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)
Time frame: Baseline
Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)
Time frame: baseline, 30 minutes
Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)
Time frame: baseline, 60 minutes
Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)
Time frame: Baseline, 120 minutes
Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)
Time frame: Baseline, 180 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)
Time frame: baseline, week 8, pre-dose
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)
Time frame: Baseline, week 8, 30 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)
Time frame: baseline, week 8, 60 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)
Time frame: baseline, week 8, 120 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)
Time frame: baseline, week 8, 180 minutes
Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)
Time frame: baseline, week 16, pre-dose
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)
Time frame: Baseline, week 16, 30 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)
Time frame: baseline, week 16, 60 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)
Time frame: baseline, week 16, 120 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)
Time frame: baseline, week 16, 180 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)
Time frame: baseline, week 24, pre-dose
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)
Time frame: baseline, week 24, 30 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)
Time frame: baseline, week 24, 60 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)
Time frame: baseline, week 24, 120 minutes
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)
Time frame: baseline, week 24, 180 minutes
FVC AUC0-3 at Baseline
Time frame: baseline
FVC AUC0-3 at Week 8 Minus Baseline
Time frame: baseline, week 8
FVC AUC0-3 at Week 16 Minus Baseline
Time frame: baseline, week 16
FVC AUC0-3 at Week 24 Minus Baseline
Time frame: baseline, week 24
Trough Forced Vital Capacity (Baseline)
Time frame: baseline
Change From Baseline in Trough Forced Vital Capacity (at Week 8)
Time frame: baseline, week 8
Change From Baseline in Trough Forced Vital Capacity (at Week 16)
Time frame: baseline, week 16
Change From Baseline in Trough Forced Vital Capacity (at Week 24)
Time frame: baseline, week 24
Peak Forced Vital Capacity (FVC) (Baseline)
Time frame: baseline
Change From Baseline in Peak Forced Vital Capacity (at Week 8)
Time frame: baseline, week 8
Change From Baseline in Peak Forced Vital Capacity (at Week 16)
Time frame: baseline, week 16
Change From Baseline in Peak Forced Vital Capacity (at Week 24)
Time frame: baseline, week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24841833Troosters T, Sciurba FC, Decramer M, Siafakas NM, Klioze SS, Sutradhar SC, Weisman IM, Yunis C. Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial. NPJ Prim Care Respir Med. 2014 May 20;24:14003. doi: 10.1038/npjpcrm.2014.3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
62 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 62 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Czechia, Ukraine, Germany, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h) (time frame: baseline, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.