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Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) 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: NCT02182583
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 efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Ba253MDI Drug: Ba253BINEB Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
Study Start Date : October 1998
Actual Primary Completion Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Ba253BINEB Drug: Ba253BINEB
Active Comparator: Ba253MDI Drug: Ba253MDI
Other Name: Tersigan® aerosol

Primary Outcome Measures :
  1. Change in COPD daily symptom scores [ Time Frame: Baseline and up to 4 weeks after first drug administration ]

Secondary Outcome Measures :
  1. Change from baseline in times of cough [ Time Frame: Baseline, up to 4 weeks after first drug administration ]
  2. Change from baseline in peak expiratory flow rate (PEFR) [ Time Frame: Baseline, up to 4 weeks after first drug administration ]
  3. Number of Patients with Adverse Events [ Time Frame: Up to 4 weeks ]
  4. Number of patients with significant changes in vital sings (blood pressure, pulse rate) [ Time Frame: Baseline, week 4 ]
  5. Number of patients with abnormal changes in electrocardiogram (ECG) [ Time Frame: Baseline, week 4 ]
  6. Number of patients with abnormal changes in laboratory values [ Time Frame: Baseline, week 4 ]
  7. Physician's global evaluation [ Time Frame: 4 weeks after first drug administration ]
  8. Patient's impression [ Time Frame: 4 weeks after first drug administration ]
  9. Change from baseline in times and volume of sputum [ Time Frame: Baseline, up to 4 weeks after first drug administration ]
  10. Change from baseline in transition of nocturnal sleep [ Time Frame: Baseline, up to 4 weeks after first drug administration ]
  11. Change from baseline in FEV1 (Forced expiratory volume in one second) [ Time Frame: Baseline, week 4 ]
  12. Change from baseline in FVC (Forced vital capacity) [ Time Frame: Baseline, week 4 ]

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 whose symptoms are stable and have at least 4 symptomatic days a week
  2. Patients with FEV1.0/FVC of <= 70% in the screening test
  3. Patients aged >= 40 years or older
  4. Patients must be able to inhale the study drug via BINEB and MDI
  5. Patients must be able to understand the patient information form

Exclusion Criteria:

Those who correspond to the following shall be excluded from the subjects of study.

  1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
  2. Patients who are constantly administered oral steroid
  3. Patients with glaucoma
  4. Patients who have prostatic hypertrophy
  5. Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
  6. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
  7. Women who are pregnant or who may become pregnant, or nursing women
  8. Patients who are judged by the investigator as inappropriate as the subjects of the study

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Responsible Party: Boehringer Ingelheim Identifier: NCT02182583    
Other Study ID Numbers: 54.560
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