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Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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. Identifier: NCT02182635
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 11, 2014
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
Pulmonary Disease, Chronic Obstructive Drug: Ba253BINEB Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 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 COPD
Study Start Date : August 1998
Actual Primary Completion Date : March 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Ba253BINEB Drug: Ba253BINEB

Primary Outcome Measures :
  1. Number of Patients with Adverse Events [ Time Frame: Up to 28 weeks ]
  2. Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate) [ Time Frame: Baseline, up to week 28 ]
  3. Number of patients with abnormal changes from baseline in electrocardiogram (ECG) [ Time Frame: Baseline, up to week 28 ]
  4. Number of patients wiht abnormal changes from baseline in laboratory tests [ Time Frame: Baseline, up to week 28 ]

Secondary Outcome Measures :
  1. Change from baseline in FEV1 (Forced expiratory volume in one second) [ Time Frame: Baseline, up to week 28 ]
  2. Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep) [ Time Frame: Baseline, up to week 28 ]
  3. Physician's global evaluation (overall improvement) [ Time Frame: Up to week 28 ]
  4. Patient's impression [ Time Frame: Week 28 ]
  5. Physician's global evaluation (final improvement) [ Time Frame: Week 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

  1. Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
  2. Patients aged >= 40 years or older
  3. Patients must be able to understand the patient information form

Exclusion Criteria:

  1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
  2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
  3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
  4. Patients with glaucoma
  5. Patients who have prostatic hypertrophy
  6. Patients with hypersensitivity to anticholinergic drugs
  7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
  8. Women who are pregnant or who may become pregnant, or nursing women
  9. Patients who are judged by the investigator as inappropriate as the subjects of the study

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Responsible Party: Boehringer Ingelheim Identifier: NCT02182635    
Other Study ID Numbers: 54.561
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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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs