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

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide hfa-134a inhalation aerosol and 84 µg 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 a stable, moderate to severe airway obstruction with an forced expiratory volume in one second (fev1) \<=65% of predicted normal and fev1 \<=70% of forced vital capacity (fvc) * 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 age 40 years or older * patients must have a smoking history of more than 10 pack-years. a pack-year is defined as the equivalent of smoking one pack of cigarettes (20 cigarettes) per day for a year * patients must be able to satisfactorily administer the medication, perform pulmonary function tests (pfts) 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 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 with may influence the results of the study or patients ability to participate in the study * patients with clinically 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 be not be conducted in these patients * patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm3. a repeat eosinophil count will be not be conducted in these patients * patients with a recent (i.e., one year or less) history of myocardial infarction * patients with a recent history (i.e., three years or less) of cardiac failure, patients with cardiac arrhythmia requiring therapy, patients receiving any systemic beta-blockers and patients on chronic daytime oxygen therapy * patients with known active tuberculosis * patients with a history of cancer within the last 5 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 of thoracotomy for other reason should be evaluated per exclusion criterion no.1 * patients with an upper respiratory tract infection or copd exacerbation in the 6 weeks prior to the screening visit (visit 1) 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 and women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or norplant®) * patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in another research study * patients with a history of and/or active alcohol or drug abuse