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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182661
• Other study ID #: 54.562
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 10, 2014
• Start date: July 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 long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. primary completion date: May 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ba253BINEB

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events		30 weeks	No
Primary	Number of patients with abnormal changes in blood pressure and heart rate		Baseline, up to 28 weeks	No
Primary	Number of patients with abnormal changes in ECG (electrocardiogram)		Baseline, up to 28 weeks	No
Primary	Number of patients with abnormal changes in laboratory parameters		Baseline, up to 28 weeks	No
Secondary	Change from baseline in symptom score		Baseline, up to 28 weeks	No
Secondary	Change from baseline in treatment score		Baseline, up to 28 weeks	No
Secondary	Change from baseline in asthma score		Baseline, week 28	No
Secondary	Change from baseline in daily life score		Baseline, up to 28 weeks	No
Secondary	Change from baseline in nocturnal sleep score		Baseline, up to 28 weeks	No
Secondary	Change from baseline in Peak expiratory flow rate (PEFR)		Baseline, up to 28 weeks	No
Secondary	Physician's global evaluation (overall improvement and final overall improvement)		Baseline, up to 28 weeks	No
Secondary	Patient's impression		Week 28	No
Secondary	Change from baseline in FEV1 (Forced expiratory volume in one second)		Baseline, up to 28 weeks	No
Secondary	Change from baseline in FVC (Forced vital capacity)		Baseline, up to 28 weeks	No

External Links

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