Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.
Interventions
DRUGCombivent® HFA inhalation aerosol
DRUGCombivent® CFC inhalation aerosol
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients 40 years of age or older 2. A diagnosis of COPD as defined by American Thoracic Society (ATS) criteria. Patients must have relatively stable, moderate to severe airway obstruction with a baseline FEV 1 \<=65% of predicted normal and FEV1/FVC \>=70%. 3. A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year 4. Able to perform technical satisfactory pulmonary function test 5. Able to be trained in the proper use of a MDI 6. Having signed an informed consent from prior to participation in the trial 7. Affiliation to the French social security system or beneficiary of such a system
Exclusion criteria
1. Significant disease other than COPD. 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 2. Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded 3. Serum glutamic oxaloacetic transaminase (SGOT) \>80 IU/L; serum glutamic pyruvic transaminase (SGPT) \>80IU/L, bilirubin \>2.0mg/dL or creatinine \>2.0mg/dL 4. Serum potassium level above or below the normal range 5. Total blood eosinophil count \>=600/mm³ 6. Recent history (i.e., one year or less) of myocardial infarction 7. Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy 8. History of cancer, other than treated basal cell carcinoma, within the last five years 9. History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis 10. History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with clinically significant changes from baseline in physical examination | Baseline, 8 days after last treatment day |
| Number of patients with clinically significant changes from baseline in clinical laboratory evaluations | Baseline, 8 days after last treatment day |
| Number of patients with adverse events including paradoxical bronchospasm | Up to 8 days after last treatment day |
| Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals) | Baseline, up to 8 days after last treatment day |
| Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate) | Baseline, up to 8 days after last treatment day |
| Changes in intra ocular pressure (IOP) | Baseline, up to 30 min after last drug administration |
| Changes in serum potassium levels | Baseline, up to 180 min after last drug administration |
| Changes in serum glucose levels | Baseline, up to 60 min after last drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Change in FVC (forced vital capacity) | Baseline, up to 180 min after last drug administration |
| Change in FEV1 (forced expiratory volume in one second) | Baseline, up to 180 min after last drug administration |
Outcome results
None listed