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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Ba253BINEB; Drug: Ba253MDI

• Registration Number: NCT02182583
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Primary Completion: 2000-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ba253BINEB	Ba253BINEB	-
Ba253MDI	Ba253MDI	-

Primary Outcome Measures

Name	Time	Method
Change in COPD daily symptom scores	Baseline and up to 4 weeks after first drug administration

Secondary Outcome Measures

Name	Time	Method
Number of Patients with Adverse Events	Up to 4 weeks
Number of patients with abnormal changes in laboratory values	Baseline, week 4
Physician's global evaluation	4 weeks after first drug administration
Change from baseline in times and volume of sputum	Baseline, up to 4 weeks after first drug administration
Change from baseline in FVC (Forced vital capacity)	Baseline, week 4
Change from baseline in times of cough	Baseline, up to 4 weeks after first drug administration
Number of patients with significant changes in vital sings (blood pressure, pulse rate)	Baseline, week 4
Change from baseline in transition of nocturnal sleep	Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)	Baseline, up to 4 weeks after first drug administration
Number of patients with abnormal changes in electrocardiogram (ECG)	Baseline, week 4
Patient's impression	4 weeks after first drug administration
Change from baseline in FEV1 (Forced expiratory volume in one second)	Baseline, week 4