study of the comparability of ipratropium bromide hydrofluoroalkane (hfa)-134a inhalation aerosol to the market standard, atrovent® chlorofluorocarbon (cfc) inhalation aerosol, in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

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


Eligibility criteria:
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 exclusion criteria for patients with allergies * patients with active infectious rhinitis (common cold) as determined by history and physical * patients with upper or lower respiratory infection at screening