Phase 3
Completed N=470
Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01019694 ↗
Enrolled (actual)
470
Serious AEs
14.6%
Results posted
May 2012
Primary outcomePrimary: Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 — 87.9; 78.3; 81.7 unit on a scale — p=< 0.0001
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 Hydrofluoroalkane (HFA) inhalation aerosols.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 |
87.9; 78.3; 81.7 | < 0.0001 sig |
| SECONDARY Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 |
84.7; 79.4; 77.3 | 0.0006 sig |
| SECONDARY Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 |
85.9; 78.0; 76.3 | < 0.0001 sig |
| SECONDARY Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 |
86.6; 77.5; 78.9 | < 0.0001 sig |
| SECONDARY Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 |
88.2; 76.9; 80.5 | < 0.0001 sig |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0 |
5.8; 5.9; 5.8 | — |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3 |
6.2; 6.1; 5.9 | 0.1167 |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12 |
6.2; 6.0; 5.8 | 0.2826 |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24 |
6.3; 6.0; 5.8 | 0.0023 sig |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36 |
6.4; 6.0; 5.9 | 0.0006 sig |
| SECONDARY Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48 |
6.3; 6.1; 6.0 | 0.0673 |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0 |
2.8; 2.7; 2.8 | — |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3 |
2.7; 2.7; 2.8 | 0.5695 |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12 |
2.8; 2.9; 2.8 | 0.3578 |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24 |
2.7; 2.8; 2.8 | 0.524 |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36 |
2.7; 2.8; 2.7 | 0.2499 |
| SECONDARY Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48 |
2.8; 2.7; 2.9 | 0.5142 |
| SECONDARY Physician's Global Evaluation at Week 0 |
5.1; 4.9; 4.9 | — |
| SECONDARY Physician's Global Evaluation at Week 3 |
5.0; 5.1; 5.1 | 0.6236 |
| SECONDARY Physician's Global Evaluation at Week 12 |
5.1; 5.2; 5.0 | 0.1884 |
| SECONDARY Physician's Global Evaluation at Week 24 |
5.1; 5.2; 5.2 | 0.4197 |
| SECONDARY Physician's Global Evaluation at Week 36 |
5.1; 5.2; 5.2 | 0.299 |
| SECONDARY Physician's Global Evaluation at Week 48 |
5.2; 5.3; 5.1 | 0.463 |
| SECONDARY Change From Baseline in FEV1 at Day 1 |
0.22; 0.21; 0.21 | 0.8282 |
| SECONDARY Change From Baseline in FEV1 at Week 12 |
0.23; 0.19; 0.20 | 0.1185 |
| SECONDARY Change From Baseline in FEV1 at Week 24 |
0.20; 0.21; 0.21 | 0.5852 |
| SECONDARY Change From Baseline in FEV1 at Week 48 |
0.22; 0.16; 0.23 | 0.0328 sig |
| SECONDARY Change From Baseline in FVC at Day 1 |
0.37; 0.34; 0.36 | 0.402 |
| SECONDARY Change From Baseline in FVC at Week 12 |
0.38; 0.31; 0.35 | 0.0893 |
| SECONDARY Change From Baseline in FVC at Week 24 |
0.33; 0.35; 0.35 | 0.6396 |
| SECONDARY Change From Baseline in FVC at Week 48 |
0.35; 0.30; 0.37 | 0.2596 |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0 |
2.1; 1.5; 1.9 | — |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3 |
1.7; 1.8; 1.7 | 0.476 |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12 |
1.9; 1.9; 1.7 | 0.9506 |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24 |
2.1; 2.0; 1.6 | 0.5645 |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36 |
1.9; 2.1; 1.8 | 0.4339 |
| SECONDARY Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48 |
2.0; 2.1; 1.8 | 0.7637 |
| SECONDARY Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
118; 113; 110; 27; 32; 37 | — |
| SECONDARY Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization |
147; 148; 146; 9; 6; 8 | — |
Eligibility Criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
- 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 b
Data sourced from ClinicalTrials.gov (NCT01019694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.