Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

July 10, 2014 updated by: Boehringer Ingelheim

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Drug: Ba253BINEB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Adverse Events
Time Frame: Up to 28 weeks
Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Time Frame: Baseline, up to week 28
Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Time Frame: Baseline, up to week 28
Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests
Time Frame: Baseline, up to week 28
Baseline, up to week 28

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

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

August 1, 1998

Primary Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 7, 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

Other Study ID Numbers

  • 54.561

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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