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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182661
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ba253BINEB Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Long-term Study of Ba253BINEB in Patients With Bronchial Asthma
Study Start Date : July 1998
Actual Primary Completion Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Ba253BINEB Drug: Ba253BINEB



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 30 weeks ]
  2. Number of patients with abnormal changes in blood pressure and heart rate [ Time Frame: Baseline, up to 28 weeks ]
  3. Number of patients with abnormal changes in ECG (electrocardiogram) [ Time Frame: Baseline, up to 28 weeks ]
  4. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline, up to 28 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in symptom score [ Time Frame: Baseline, up to 28 weeks ]
  2. Change from baseline in treatment score [ Time Frame: Baseline, up to 28 weeks ]
  3. Change from baseline in asthma score [ Time Frame: Baseline, week 28 ]
  4. Change from baseline in daily life score [ Time Frame: Baseline, up to 28 weeks ]
  5. Change from baseline in nocturnal sleep score [ Time Frame: Baseline, up to 28 weeks ]
  6. Change from baseline in Peak expiratory flow rate (PEFR) [ Time Frame: Baseline, up to 28 weeks ]
  7. Physician's global evaluation (overall improvement and final overall improvement) [ Time Frame: Baseline, up to 28 weeks ]
  8. Patient's impression [ Time Frame: Week 28 ]
  9. Change from baseline in FEV1 (Forced expiratory volume in one second) [ Time Frame: Baseline, up to 28 weeks ]
  10. Change from baseline in FVC (Forced vital capacity) [ Time Frame: Baseline, up to 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182661    
Other Study ID Numbers: 54.562
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Oxitropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs