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

NCT02182661 | Completed Phase 3

• 1 other identifier: 54.562
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (1)

Ba253BINEB

EXPERIMENTAL

Drug: Ba253BINEB

Interventions

Ba253BINEB DRUG

Ba253BINEB

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with bronchial asthma and who satisfy the following criteria
• Patients aged \>= 20 years or older
• Patients with mild to moderate severity
• Patients must be able to understand the patient information form

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 1998
• Primary Completion: May 1, 2000
• Last Updated: July 11, 2014

Record last verified: 2014-07