Pulmonary Disease, Chronic ObstructivePhase 3NCT01019694
Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Combivent CFC-MDI, Combivent Respimat 20/100 mcg and Atrovent HFA 42 mcg + Albuterol HFA 200 mcg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 55 sites in United States.
Trial summary
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Combivent CFC-MDI, Combivent Respimat 20/100 mcg and Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 55 sitesUnited States
- Study dates
- Nov 2009to Apr 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must sign an informed consent consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation in the trial.
- Male or female patients 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack
- All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) < 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x [height (inches) / 39.37]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x [height (inches) / 39.37]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x [height (meters)] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x [height (meters)] - 0.025 x age (years) - 2.60
- Patients must be able to perform all study related procedures and maintain study records during the study period as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
Who cannot join
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- Patients with a recent history (i.e., one year or less) of myocardial infarction.
- Patients who have been hospitalized or being treated for heart failure within the past year.
- Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year.
- Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed).
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
Show all 20Show fewer
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
- Patients with a current diagnosis of asthma.
- Patients with a history of significant alcohol or drug abuse.
- Patients with known active tuberculosis.
- Patients using beta blocker medications are excluded. Cardioselective beta blockers are allowed with caution. Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed.
- Patients who regularly use daytime oxygen therapy for more than 1 hour per day Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed).
- Patients using oral corticosteroid medication at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, except as required for treatment of exacerbation during the study.
- Pregnant or nursing women.
- Women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a medically approved means of contraception. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Patients with known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride (BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components.
- Previous participation in this study. (The patient cannot re-enroll into this study.)
- Patients who are currently participating in another interventional study.
- Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening.
- Patients currently in any pulmonary rehabilitation program or scheduled to participate in any such program during the study period.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
1012.62.112 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1012.62.132 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
1012.62.125 Boehringer Ingelheim Investigational Site
Austin, Texas
1012.62.135 Boehringer Ingelheim Investigational Site
Berkeley, California
1012.62.155 Boehringer Ingelheim Investigational Site
Boulder, Colorado
1012.62.128 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1012.62.147 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey
1012.62.107 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1012.62.120 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1012.62.114 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1012.62.113 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
1012.62.122 Boehringer Ingelheim Investigational Site
Danville, Virginia
1012.62.146 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1012.62.124 Boehringer Ingelheim Investigational Site
DeLand, Florida
1012.62.157 Boehringer Ingelheim Investigational Site
Dubuque, Iowa
1012.62.130 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1012.62.154 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island
1012.62.126 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
1012.62.140 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1012.62.151 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1012.62.161 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1012.62.109 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1012.62.143 Boehringer Ingelheim Investigational Site
Houston, Texas
1012.62.153 Boehringer Ingelheim Investigational Site
Jasper, Alabama
1012.62.152 Boehringer Ingelheim Investigational Site
Killeen, Texas
1012.62.116 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
1012.62.117 Boehringer Ingelheim Investigational Site
Livonia, Michigan
1012.62.159 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1012.62.156 Boehringer Ingelheim Investigational Site
Mesa, Arizona
1012.62.158 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1012.62.145 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1012.62.101 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia
1012.62.148 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1012.62.137 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1012.62.139 Boehringer Ingelheim Investigational Site
Pensacola, Florida
1012.62.103 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1012.62.104 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1012.62.119 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1012.62.142 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1012.62.141 Boehringer Ingelheim Investigational Site
Riverside, California
1012.62.111 Boehringer Ingelheim Investigational Site
Rochester, New York
1012.62.102 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1012.62.118 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1012.62.108 Boehringer Ingelheim Investigational Site
Spokane, Washington
1012.62.133 Boehringer Ingelheim Investigational Site
Spokane, Washington
1012.62.127 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1012.62.129 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1012.62.144 Boehringer Ingelheim Investigational Site
Stamford, Connecticut
1012.62.149 Boehringer Ingelheim Investigational Site
Summit, New Jersey
1012.62.105 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1012.62.134 Boehringer Ingelheim Investigational Site
Tampa, Florida
1012.62.150 Boehringer Ingelheim Investigational Site
Toledo, Ohio
1012.62.123 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
1012.62.131 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
1012.62.115 Boehringer Ingelheim Investigational Site
Winter Park, Florida
About this study
Official title: Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Combivent CFC-MDI, Combivent Respimat 20/100 mcg, Atrovent HFA 42 mcg + Albuterol HFA 200 mcg
- 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.
Combivent CFC-MDIDrug
36/206 mcg Four times a day (QID)
Combivent Respimat 20/100 mcgDrug
Open label randomized parallel
Atrovent HFA 42 mcg + Albuterol HFA 200 mcgDrug
Open label randomized parallel
| Study group | Role | What they receive |
|---|---|---|
| Combivent Respimat 20/100 microgram(mcg) | Experimental | patient to take 1 inhalation 4 times a day Receives: Drug: Combivent Respimat 20/100 mcg |
| Combivent CFC-MDI 36/206 microgram-mcg | Active comparator | patient to take 2 inhalations 4 times a day Receives: Drug: Combivent CFC-MDI |
| Atrovent HFA 42 mcg + Albuterol HFA | Active comparator | patient to take 2 inhalations of each 4 times a day Receives: Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Measured: 48 weeks
Secondary outcomes (38)
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Measured: 3 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Measured: 12 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Measured: 24 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
Measured: 36 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 0 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 3 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 12 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 24 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 36 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).
Measured: 48 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 0 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 3 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 12 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 24 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 36 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).
Measured: 48 weeks
Physician's Global Evaluation at Week 0
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 0 weeks
Physician's Global Evaluation at Week 3
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 3 weeks
Physician's Global Evaluation at Week 12
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 12 weeks
Physician's Global Evaluation at Week 24
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 24 weeks
Physician's Global Evaluation at Week 36
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 36 weeks
Physician's Global Evaluation at Week 48
Physicians evaluated the patient's overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).
Measured: 48 weeks
Change From Baseline in FEV1 at Day 1
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.
Measured: baseline, day 1
Change From Baseline in FEV1 at Week 12
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12
Measured: baseline, 12 weeks
Change From Baseline in FEV1 at Week 24
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24
Measured: baseline, 24 weeks
Change From Baseline in FEV1 at Week 48
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48
Measured: baseline, 48 weeks
Change From Baseline in FVC at Day 1
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.
Measured: baseline, day 1
Change From Baseline in FVC at Week 12
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12
Measured: baseline, 12 weeks
Change From Baseline in FVC at Week 24
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24
Measured: baseline, 24 weeks
Change From Baseline in FVC at Week 48
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48
Measured: baseline, 48 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0
Measured: 0 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3
Measured: 3 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12
Measured: 12 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24
Measured: 24 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36
Measured: 36 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48
Measured: 48 weeks
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Measured: 48 weeks
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019694
- Sponsor's protocol ID
- 1012.62
- Status last verified
- Oct 2014
- First submitted
- 16 Nov 2009
- Last updated
- 23 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.
PubMed 23658479
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01019694
- Acronym / sponsor ID
- 1012.62
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 1 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combivent Respimat 20/100 microgram(mcg) | Experimental | Drug: Combivent Respimat 20/100 mcgpatient to take 1 inhalation 4 times a day |
| Combivent CFC-MDI 36/206 microgram-mcg | Active comparator | Drug: Combivent CFC-MDIpatient to take 2 inhalations 4 times a day |
| Atrovent HFA 42 mcg + Albuterol HFA | Active comparator | Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcgpatient to take 2 inhalations of each 4 times a day |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must sign an informed consent consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation in the trial.
- Male or female patients 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack
- All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) < 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x [height (inches) / 39.37]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x [height (inches) / 39.37]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x [height (meters)] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x [height (meters)] - 0.025 x age (years) - 2.60
- Patients must be able to perform all study related procedures and maintain study records during the study period as required in the protocol.
Key exclusion criteria (20 listed)
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- Patients with a recent history (i.e., one year or less) of myocardial infarction.
- Patients who have been hospitalized or being treated for heart failure within the past year.
- Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year.
- Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed).
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 |
|---|---|---|
| Combivent CFC-MDI36/206 mcg Four times a day (QID) | Drug | Combivent CFC-MDI 36/206 microgram-mcg |
| Combivent Respimat 20/100 mcgOpen label randomized parallel | Drug | Combivent Respimat 20/100 microgram(mcg) |
| Atrovent HFA 42 mcg + Albuterol HFA 200 mcgOpen label randomized parallel | Drug | Atrovent HFA 42 mcg + Albuterol HFA |
Primary outcome
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Time frame: 48 weeks
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).
38 secondary outcomes
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Time frame: 3 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Time frame: 12 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Time frame: 24 weeks
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Time frame: 36 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0
Time frame: 0 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3
Time frame: 3 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12
Time frame: 12 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24
Time frame: 24 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36
Time frame: 36 weeks
Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48
Time frame: 48 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0
Time frame: 0 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3
Time frame: 3 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12
Time frame: 12 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24
Time frame: 24 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36
Time frame: 36 weeks
Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48
Time frame: 48 weeks
Physician's Global Evaluation at Week 0
Time frame: 0 weeks
Physician's Global Evaluation at Week 3
Time frame: 3 weeks
Physician's Global Evaluation at Week 12
Time frame: 12 weeks
Physician's Global Evaluation at Week 24
Time frame: 24 weeks
Physician's Global Evaluation at Week 36
Time frame: 36 weeks
Physician's Global Evaluation at Week 48
Time frame: 48 weeks
Change From Baseline in FEV1 at Day 1
Time frame: baseline, day 1
Change From Baseline in FEV1 at Week 12
Time frame: baseline, 12 weeks
Change From Baseline in FEV1 at Week 24
Time frame: baseline, 24 weeks
Change From Baseline in FEV1 at Week 48
Time frame: baseline, 48 weeks
Change From Baseline in FVC at Day 1
Time frame: baseline, day 1
Change From Baseline in FVC at Week 12
Time frame: baseline, 12 weeks
Change From Baseline in FVC at Week 24
Time frame: baseline, 24 weeks
Change From Baseline in FVC at Week 48
Time frame: baseline, 48 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0
Time frame: 0 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3
Time frame: 3 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12
Time frame: 12 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24
Time frame: 24 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36
Time frame: 36 weeks
Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48
Time frame: 48 weeks
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Time frame: 48 weeks
Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23658479Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combivent CFC-MDI, Combivent Respimat 20/100 mcg and Atrovent HFA 42 mcg + Albuterol HFA 200 mcg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 55 sites in United States.
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 6 inclusion and 20 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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 May 2012). 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?
Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 (time frame: 48 weeks). 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 NCT01019694, 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 23 Oct 2014.