A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Ba253BINEB

• Registration Number: NCT02182661
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07
• Primary Completion: 2000-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• 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: 88

Inclusion Criteria

The patients with bronchial asthma and who satisfy the following criteria

1. Patients aged >= 20 years or older
2. Patients with mild to moderate severity
3. Patients must be able to understand the patient information form

Exclusion Criteria

1. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the screening test
2. Patients using corticosteroid medication( p.o./ i.h.) at a dose in excess of the equivalent 10 mg/day of prednisolone
3. Patients with glaucoma
4. Patients who have prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs
6. Patients who began treatment with hyposensitization or immunoregulator therapy within 3 month before the screening test
7. Patients complicated with chronic bronchitis, emphysema or bronchiectasis, making the assessment of drug efficacy against bronchial asthma difficult
8. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
9. Women who are pregnant or who may become pregnant, or nursing women
10. Patients who are judged by the investigator as inappropriate as the subjects of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ba253BINEB	Ba253BINEB	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	30 weeks
Number of patients with abnormal changes in blood pressure and heart rate	Baseline, up to 28 weeks
Number of patients with abnormal changes in ECG (electrocardiogram)	Baseline, up to 28 weeks
Number of patients with abnormal changes in laboratory parameters	Baseline, up to 28 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in symptom score	Baseline, up to 28 weeks
Change from baseline in treatment score	Baseline, up to 28 weeks
Change from baseline in asthma score	Baseline, week 28
Change from baseline in daily life score	Baseline, up to 28 weeks
Change from baseline in nocturnal sleep score	Baseline, up to 28 weeks
Change from baseline in Peak expiratory flow rate (PEFR)	Baseline, up to 28 weeks
Physician's global evaluation (overall improvement and final overall improvement)	Baseline, up to 28 weeks
Patient's impression	Week 28
Change from baseline in FEV1 (Forced expiratory volume in one second)	Baseline, up to 28 weeks
Change from baseline in FVC (Forced vital capacity)	Baseline, up to 28 weeks