Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients
Interventions
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
All patients must have a diagnosis of COPD and must meet the following spirometric criteria: * Patients must have stable, moderate to severe airway obstruction with an FEV 1 (forced expiratory volume in the first second) \<=65% of predicted normal and FEV1 \<=70% of FVC (Forced Vital Capacity) * Males: Predicted normal FEV1=0.093 (height in inches) - 0.032(Age) - 1.343 * Females: Predicted normal FEV1=0.085 (height in inches) - 0.025(Age) - 1.692 * Male or female patients 40 years of age or older * Patients must have a smoking history of more than ten pack-years * Patients must be able to demonstrate an improvement in FEV1 \>=015% within one hour after inhalation of two puffs of Atrovent® inhalation aerosol (21 mcg per puff) * Patients must be able to satisfactorily administer the medication, perform pulmonary function test and maintain records during the study period as required in the protocol * All patients must sign an informed consent form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)
Exclusion criteria
* Patients with significant disease other than COPD were 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 clinical relevant baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded * All patients with serum glutamic oxaloacetic transaminase (SGOT) \>80 IU/L; serum glutamic pyruvic transaminase (SGPT) \>80 IU/L, bilirubin \>2.0 mg/dL, or creatinine \>2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not to be conducted in these patients * Patients with a history of asthma, allergic rhinitis or atopy or have a blood eosinophil count above 600/mm³. A repeat eosinophil count will not to be conducted in these patients * Patients with a recent history (i.e., one year or less) of myocardial infarction * Patients with a recent history (i.e., three years or less) of heart failure, patients with any cardiac arrhythmia requiring therapy, patients receiving any systemic beta blocker and patients on chronic daytime oxygen therapy * Patients with known active tuberculosis * Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed * Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis * Patients who have undergone thoracotomy with pulmonary resection. Patients with a history or a thoracotomy for other reasons be evaluated as per exclusion criterion No. 1 * Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit (vist1) or during the baseline period * Patients with known hypersensitivity to anticholinergic drugs * Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction * Patients with known narrow-angle glaucoma * Patients who are on cromolyn sodium or nedocromil sodium * Patients who are on antihistamines * Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptives, intrauterine devices, diaphragm or Norplant®) * Patients who have taken an investigational drug within one month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in other research study * Patients with a history of and/or active alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6) | After each drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Onset of therapeutic FEV1 response | After each drug administration |
| Duration of therapeutic FEV1 response | After each drug administration |
| Time to peak FEV1 response | After each drug administration |
| Forced Vital Capacity (FVC) AUC0-6 | After each drug administration |
| Changes in peak FEV1 response | Baseline and after each drug administration |
| Number of patients with adverse events | Up to 5 month after first drug administration |
| Peak FVC response | After each drug administration |
| Changes from baseline in FVC | Baseline and after each drug administration |
| Changes from baseline in FEV1 | Baseline and after each drug administration |
Outcome results
None listed