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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172807
• Other study ID #: 205.226
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: December 2000

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 ß2 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 ß-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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium low
Tiotropium 18 µg inhalation capsule
• Tiotropium high
Tiotropium 36 µg inhalation capsule
• Placebo MDI
Placebo metered dose inhaler (MDI)
• Placebo inhalation capsule

• Oxitropium
Oxitropium MDI (100 µg/puff)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough forced expiratory volume in one second (FEV1.0) response		Day 1, week 2 and 4	No
Secondary	FEV1.0 response at 1 hour after administration		Day 1, week 2 and 4	No
Secondary	Trough forced vital capacity (FVC) response		Day 1, week 2 and 4	No
Secondary	FVC response at 1 hour after administration		Day 1, week 2 and 4	No
Secondary	Peak expiratory flow rate (PEF)		in the morning and at evening every day until week 4	No
Secondary	COPD symptom scores		until week 4	No
Secondary	Frequency of rescue use of ß2 stimulant		until week 4	No
Secondary	Patient's impression		week 4	No
Secondary	Physician's global evaluation		week 4	No
Secondary	Occurrence of Adverse Events		up to 4 weeks	No
Secondary	Change from baseline in blood pressure		Baseline, week 4	No
Secondary	Change from baseline in heart rate		Baseline, week 4	No
Secondary	Changes in ECG findings		Baseline, week 4	No
Secondary	Changes from baseline in laboratory values		Baseline, week 4	No

External Links

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