Clinical trial NCT02182661: A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
Official title: A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 30 weeks
measure: Number of patients with abnormal changes in blood pressure and heart rate
timeFrame: Baseline, up to 28 weeks
measure: Number of patients with abnormal changes in ECG (electrocardiogram)
timeFrame: Baseline, up to 28 weeks
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: Baseline, up to 28 weeks
Secondary outcomes:
measure: Change from baseline in symptom score
timeFrame: Baseline, up to 28 weeks
measure: Change from baseline in treatment score
timeFrame: Baseline, up to 28 weeks
measure: Change from baseline in asthma score
timeFrame: Baseline, week 28
measure: Change from baseline in daily life score
timeFrame: Baseline, up to 28 weeks
measure: Change from baseline in nocturnal sleep score
timeFrame: Baseline, up to 28 weeks
measure: Change from baseline in Peak expiratory flow rate (PEFR)
timeFrame: Baseline, up to 28 weeks
measure: Physician's global evaluation (overall improvement and final overall improvement)
timeFrame: Baseline, up to 28 weeks
measure: Patient's impression
timeFrame: Week 28
measure: Change from baseline in FEV1 (Forced expiratory volume in one second)
timeFrame: Baseline, up to 28 weeks
measure: Change from baseline in FVC (Forced vital capacity)
timeFrame: Baseline, up to 28 weeks
Other outcomes:
Locations:
Study officials:
References: