- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02182661
A Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
July 10, 2014 updated by: Boehringer Ingelheim
A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
The objective of this study is to investigate the long-term safety of Ba253BINEB.
Secondarily the long-term efficacy of Ba253BINEB is also investigated.
Study Overview
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ba253BINEB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: 30 weeks
|
30 weeks
|
Number of patients with abnormal changes in blood pressure and heart rate
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Number of patients with abnormal changes in ECG (electrocardiogram)
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Number of patients with abnormal changes in laboratory parameters
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient's impression
Time Frame: Week 28
|
Week 28
|
Change from baseline in symptom score
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in treatment score
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in asthma score
Time Frame: Baseline, week 28
|
Baseline, week 28
|
Change from baseline in daily life score
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in nocturnal sleep score
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in Peak expiratory flow rate (PEFR)
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Physician's global evaluation (overall improvement and final overall improvement)
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Change from baseline in FVC (Forced vital capacity)
Time Frame: Baseline, up to 28 weeks
|
Baseline, up to 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Primary Completion (Actual)
May 1, 2000
Study Registration Dates
First Submitted
July 2, 2014
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 11, 2014
Last Update Submitted That Met QC Criteria
July 10, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Oxitropium
Other Study ID Numbers
- 54.562
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Ba253BINEB
-
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