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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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

Other trials in Czechia

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

Other trials in Ukraine

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

Other trials in Germany

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

Other trials in Belgium

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

Other trials in Canada

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

Other trials in Netherlands

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

Other trials in Greece

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

Other trials in Portugal

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

Other trials in United Kingdom

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.

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 groups in NCT00523991
Study groupRoleWhat they receive
placeboPlacebo comparatorOral inhalation once daily of placebo matching tiotropium via handihaler
Receives: Drug: Placebo
tiotropiumExperimentalOral 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)

    Forced expiratory volume in 1 second (baseline, pre-dose)

    Measured: Baseline

  10. Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)

    Forced expiratory volume in 1 second (baseline, 30 minutes)

    Measured: baseline, 30 minutes

  11. Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)

    Forced expiratory volume in 1 second (baseline, 60 minutes)

    Measured: baseline, 60 minutes

  12. Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)

    Forced expiratory volume in 1 second (baseline, 120 minutes)

    Measured: Baseline, 120 minutes

  13. Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)

    Forced expiratory volume in 1 second (baseline, 180 minutes)

    Measured: Baseline, 180 minutes

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. FVC AUC0-3 at Baseline

    Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

    Measured: baseline

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. Forced Vital Capacity (Baseline, Pre-dose)

    Forced vital capacity (baseline, pre-dose)

    Measured: baseline

  42. Forced Vital Capacity (Baseline, 30 Minutes)

    Forced vital capacity (baseline, 30 minutes)

    Measured: baseline, 30 minutes

  43. Forced Vital Capacity (Baseline, 60 Minutes)

    Forced vital capacity (baseline, 60 minutes)

    Measured: baseline, 60 minutes

  44. Forced Vital Capacity (Baseline, 120 Minutes)

    Forced vital capacity (baseline, 120 minutes)

    Measured: baseline, 120 minutes

  45. Forced Vital Capacity (Baseline, 180 Minutes)

    Forced vital capacity (baseline, 180 minutes)

    Measured: baseline, 180 minutes

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. Albuterol Use p.r.n. (Baseline)

    Number of days that participants used albuterol prn per week

    Measured: baseline

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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

  101. 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

  102. 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

  103. 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

  104. 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

  105. 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

  106. 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

  107. 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

  108. 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

  109. 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

  110. 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

  111. 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

  112. 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

  113. 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

  114. 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

  115. 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

  116. 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

  117. 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

  118. 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

  119. 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

  120. 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

  121. 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

  122. 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

  123. Active Energy Expenditure (Baseline)

    The amount of energy (kcal/day) that a person uses while physically active.

    Measured: baseline

  124. 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

  125. 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

  126. 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

  127. 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

  128. 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

  129. 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

  130. Number of Steps Per Day (Baseline)

    Number of steps per day (baseline)

    Measured: baseline

  131. 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

  132. 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

  133. 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

  134. 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

  135. 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

  136. 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.

  1. First posted3 Sep 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionJul 2010

Resources

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)
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

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

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.

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