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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ba253BINEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182661

54.562

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

Ba253BINEB

Experimental group

Treatment:

Drug: Ba253BINEB