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Completed

NCT Number: NCT02182635

Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

  • Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
  • Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
  • Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
  • Patients with glaucoma
  • Patients who have prostatic hypertrophy
  • Patients with hypersensitivity to anticholinergic drugs
  • 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

Treatment and study plan

Ba253BINEB

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase III Long-term Study of Ba253BINEB in Patients With COPD

Important dates

Study start
1998
Primary completion
1999
First posted
Jul 8, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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