Clinical trial NCT02172807: Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 201
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Trough forced expiratory volume in one second (FEV1.0) response
timeFrame: Day 1, week 2 and 4
Secondary outcomes:
measure: FEV1.0 response at 1 hour after administration
timeFrame: Day 1, week 2 and 4
measure: Trough forced vital capacity (FVC) response
timeFrame: Day 1, week 2 and 4
measure: FVC response at 1 hour after administration
timeFrame: Day 1, week 2 and 4
measure: Peak expiratory flow rate (PEF)
timeFrame: in the morning and at evening every day until week 4
measure: COPD symptom scores
timeFrame: until week 4
measure: Frequency of rescue use of β2 stimulant
timeFrame: until week 4
measure: Patient's impression
timeFrame: week 4
measure: Physician's global evaluation
timeFrame: week 4
measure: Occurrence of Adverse Events
timeFrame: up to 4 weeks
measure: Change from baseline in blood pressure
timeFrame: Baseline, week 4
measure: Change from baseline in heart rate
timeFrame: Baseline, week 4
measure: Changes in ECG findings
timeFrame: Baseline, week 4
measure: Changes from baseline in laboratory values
timeFrame: Baseline, week 4
Other outcomes:
Locations:
Study officials:
References: