Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182583
• Other study ID #: 54.560
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 10, 2014
• Start date: October 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients whose symptoms are stable and have at least 4 symptomatic days a week

2. Patients with FEV1.0/FVC of <= 70% in the screening test

3. Patients aged >= 40 years or older

4. Patients must be able to inhale the study drug via BINEB and MDI

5. Patients must be able to understand the patient information form

Exclusion Criteria:

Those who correspond to the following shall be excluded from the subjects of study.

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult

2. Patients who are constantly administered oral steroid

3. Patients with glaucoma

4. Patients who have prostatic hypertrophy

5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.

6. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study

7. Women who are pregnant or who may become pregnant, or nursing women

8. Patients who are judged by the investigator as inappropriate as the subjects of the study

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ba253MDI

• Ba253BINEB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in COPD daily symptom scores		Baseline and up to 4 weeks after first drug administration	No
Secondary	Change from baseline in times of cough		Baseline, up to 4 weeks after first drug administration	No
Secondary	Change from baseline in peak expiratory flow rate (PEFR)		Baseline, up to 4 weeks after first drug administration	No
Secondary	Number of Patients with Adverse Events		Up to 4 weeks	No
Secondary	Number of patients with significant changes in vital sings (blood pressure, pulse rate)		Baseline, week 4	No
Secondary	Number of patients with abnormal changes in electrocardiogram (ECG)		Baseline, week 4	No
Secondary	Number of patients with abnormal changes in laboratory values		Baseline, week 4	No
Secondary	Physician's global evaluation		4 weeks after first drug administration	No
Secondary	Patient's impression		4 weeks after first drug administration	No
Secondary	Change from baseline in times and volume of sputum		Baseline, up to 4 weeks after first drug administration	No
Secondary	Change from baseline in transition of nocturnal sleep		Baseline, up to 4 weeks after first drug administration	No
Secondary	Change from baseline in FEV1 (Forced expiratory volume in one second)		Baseline, week 4	No
Secondary	Change from baseline in FVC (Forced vital capacity)		Baseline, week 4	No

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