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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium low; Drug: Tiotropium high; Drug: Placebo inhalation capsule; Drug: Placebo MDI; Drug: Oxitropium

• Registration Number: NCT02172807
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2001-09
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium low & Placebo	Tiotropium low	Tiotropium 18 µg inhalation capsule and Placebo MDI
Tiotropium low & Placebo	Placebo MDI	Tiotropium 18 µg inhalation capsule and Placebo MDI
Tiotropium high & Placebo	Tiotropium high	Tiotropium 36 µg inhalation capsule and Placebo MDI
Tiotropium high & Placebo	Placebo MDI	Tiotropium 36 µg inhalation capsule and Placebo MDI
Oxitropium & Placebo	Placebo inhalation capsule	Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules
Oxitropium & Placebo	Oxitropium	Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules

Primary Outcome Measures

Name	Time	Method
Trough forced expiratory volume in one second (FEV1.0) response	Day 1, week 2 and 4

Secondary Outcome Measures

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