study to assess the safety of ipratropium bromide, in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the respimat® device and as determined by 24 hours ambulatory ecg monitoring in copd patients. to assess the overall safety of the two doses of ipratropium bromide as delivered by the respimat® device when administered over a two-week period.


Eligibility criteria:
inclusion criteria: all patients must have a diagnosis of copd and must meet the following spirometric criteria: * patients must have relatively stable, moderate to severe airway obstruction with an fev1 \<=65% of predicted normal and fev1 \<=70% of forced vital capacity (fvc). predicted normal value will be calculated according to morris * males: fev1 = 0.093 (height in inches)-0.032 (age)-1.343 * females: 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 10 pack-years. a pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year * patients must be able to perform pulmonary function tests (pfts) and maintain records during the study period as required in the protocol * patients must be able to be trained in the proper use of an inhalation aerosol and the respimat™ device * patients must have a baseline electrocardiogram (ecg) with no clinical relevant arrhythmias or conduction system disease (e.g. right or left bundle branch block, second degree av block or higher) * patients must have an oxygen saturation of \>=90% for \>=92% of the recording time on overnight oximetry * all patients must sign an informed consent form prior to participation in the trial (i.e., at least 24 hours (h) prior to the screening visit (visit 1)) exclusion criteria: * patients with clinically relevant diseases other than copd will be excluded. a clinically relevant 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 patient's ability to participate in the study * patients with a recent history (i.e. one year or less) of myocardial infarction * patients with a recent history (i.e. one year or less) of heart failure or patients with any past history or active cardiac arrhythmia requiring drug therapy * patients who have a pacemaker * patients with clinically relevant abnormal 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 / aspartate aminotransferase (sgot/ast) \>80 iu/l, serum glutamic pyruvic transaminase / alanine transaminase (sgpt/alt) \>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 subjects * patients who have a blood eosinophil count \>=600/mm3. a repeat eosinophil count will be not be conducted in these patients * patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years * 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 a history of asthma, allergic rhinitis or atopy * patients with a history of and/or active alcohol or drug abuse * patients with known active tuberculosis * patients with an upper respiratory tract infection or copd exacerbation in the past 6 weeks prior to the screening visit (visit 1) or during the baseline period * patients with known symptomatic prostatic hypertrophy or bladder neck obstruction * patients with known narrow-angle glaucoma * patients with current significant psychiatric disorders * patients with regular use of daytime oxygen therapy * patients who are being treated with cromolyn sodium or nedocromil sodium * patients who are being treated with antihistamines * patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day * patients who are being treated with beta-blocker medication * patients who have had changes in their therapeutic plan within the last six weeks prior to the screening visit (visit 1) * pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or norplant®) * patients with known hypersensitivity to ant cholinergic drugs or any other components of the atrovent® respimat™ solution including bacteriostatic agent benzalkonium chlorid (bac) and edetic acid (edta) * patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) prior to the screening visit (visit1) * previous participation in this study