Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive Read More

Inclusion Criteria:

• All patients must have a diagnosis of COPD and the following spirometric criteria:

  • Visit 1 (Screening) and Visit 2: Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤65% of predicted normal and FEV1 ≤70% of FVC
• Male or female patients 40 years of age or older
• Patients must have 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
• Patients must be able to perform pulmonary function tests 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 MDI (metered dose inhaler) and the Respimat® inhaler
• All patients must sign an Informed Consent Form prior to participation in the trial

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 which may influence the results of the study or the patient's ability to participate in the study
• 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 a SGOT (serum glutamic oxaloacetic transaminase) >80 IU/L, SGPT (serum glutamic pyruvic transaminase) >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL will be excluded regardless of the clinical condition
• Patients who have a total blood eosinophil count ≥600/mm3
• 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 or patients with any cardiac arrhythmia requiring drug therapy
• 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 clinically evident bronchiectasis
• Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
• Patients with a history of asthma or allergic rhinitis
• Patients with a history of and/or active alcohol or drug abuse
• Patients with known active tuberculosis
• Patients with an upper or lower 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 symptomatic prostatic hypertrophy or bladder neck obstruction
• Patients with known narrow-angle glaucoma
• Patients with current significant psychiatric disorders
• Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy
• Patients who are being treated with cromolyn sodium or nedocromil sodium
• Patients who are being treated with antihistamines for any excluded allergic conditions
• Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 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 initiated use of an inhaled steroid or changed doses less than 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period
• Patients who are being treated with beta-blocker medications, MAO (monoamine oxidase) inhibitors or tricyclic antidepressants. Beta blocker eye medications (e.g., Betoptic) for treatment of non-narrow angle glaucoma are allowed
• Patients who have had changes in their therapeutic plan within the last 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
• Patients with known hypersensitivity to anticholinergic drugs or any component of the ipratropium bromide/salbutamol Respimat® solution (including BAC (Benzalkonium chloride) and EDTA (Ethylenediaminetetraacetic acid)) or the ipratropium bromide/salbutamol MDI components
• Previous participation in this study
• Patients who are currently participating in another study