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

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 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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Tiotropium low; Drug: Placebo MDI; Drug: Tiotropium high; Drug: Placebo inhalation capsule; Drug: Oxitropium

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium low & Placebo; Tiotropium 18 µg inhalation capsule and Placebo MDI	Drug: Tiotropium low; Tiotropium 18 µg inhalation capsule; Drug: Placebo MDI; Placebo metered dose inhaler (MDI)
Experimental: Tiotropium high & Placebo; Tiotropium 36 µg inhalation capsule and Placebo MDI	Drug: Placebo MDI; Placebo metered dose inhaler (MDI); Drug: Tiotropium high; Tiotropium 36 µg inhalation capsule
Active Comparator: Oxitropium & Placebo; Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules	Drug: Placebo inhalation capsule; Drug: Oxitropium; Oxitropium MDI (100 µg/puff); Other Names: Tersigan®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Adverse Events	up to 4 weeks
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
Patient's impression	week 4
Physician's global evaluation	week 4
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): September 1, 2001

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Oxitropium
• Other Study ID Numbers: 205.226