Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

July 10, 2014 updated by: Boehringer Ingelheim

A Phase III Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

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 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ba253BINEB
Drug: Ba253BINEB
Active Comparator: Ba253MDI
Drug: Ba253MDI
Other Names:
  • Tersigan® aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in COPD daily symptom scores
Time Frame: Baseline and up to 4 weeks after first drug administration
Baseline and up to 4 weeks after first drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in times of cough
Time Frame: Baseline, up to 4 weeks after first drug administration
Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)
Time Frame: Baseline, up to 4 weeks after first drug administration
Baseline, up to 4 weeks after first drug administration
Number of Patients with Adverse Events
Time Frame: Up to 4 weeks
Up to 4 weeks
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Time Frame: Baseline, week 4
Baseline, week 4
Number of patients with abnormal changes in electrocardiogram (ECG)
Time Frame: Baseline, week 4
Baseline, week 4
Number of patients with abnormal changes in laboratory values
Time Frame: Baseline, week 4
Baseline, week 4
Physician's global evaluation
Time Frame: 4 weeks after first drug administration
4 weeks after first drug administration
Patient's impression
Time Frame: 4 weeks after first drug administration
4 weeks after first drug administration
Change from baseline in times and volume of sputum
Time Frame: Baseline, up to 4 weeks after first drug administration
Baseline, up to 4 weeks after first drug administration
Change from baseline in transition of nocturnal sleep
Time Frame: Baseline, up to 4 weeks after first drug administration
Baseline, up to 4 weeks after first drug administration
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time Frame: Baseline, week 4
Baseline, week 4
Change from baseline in FVC (Forced vital capacity)
Time Frame: Baseline, week 4
Baseline, week 4

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

October 1, 1998

Primary Completion (Actual)

June 1, 2000

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

  • 54.560

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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