Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Oxitropium; Tiotropium Bromide

Criteria

Inclusion Criteria:

Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:

• Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)

• Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)

• Male or female patients 40 years of age or older

Exclusion Criteria:

• History of bronchial asthma

• History of an atopic disease such as allergic rhinitis

• Total blood eosinophil count ≥ 600/µL

• Patient treated with antiallergic drugs or anti-histamine drugs

• Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day

• Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)

• Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)

• Patients with known narrow-angle glaucoma

• Patients with known symptomatic prostatic hypertrophy

• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system

• Patients with significant diseases who in the opinion of the investigator were not eligible for the study

• Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded

• Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure

• Patients with any cardiac arrhythmia requiring drug therapy

• Patients who were treated with Patients who were treated with β-blockers-blockers

• Patients with regular use of daytime oxygen therapy

• Patients with known active tuberculosis or with obvious sequela of tuberculosis

• Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed

• Patients with a history of cystic fibrosis or bronchiectasis

• Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period

• Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit

• Pregnant or nursing women or women of childbearing potential

• Other than the above, patients who in the opinion of the investigator were not eligible for the study