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Clinical Trials/NCT02182635
NCT02182635CompletedPhase 3

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

Boehringer Ingelheim0 sites74 target enrollmentStarted: August 1998Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
74
Primary Endpoint
Number of Patients with Adverse Events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Ba253BINEB

Experimental

Intervention: Ba253BINEB (Drug)

Outcomes

Primary Outcomes

Number of Patients with Adverse Events

Time Frame: 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

Number of patients with abnormal changes from baseline in electrocardiogram (ECG)

Time Frame: Baseline, up to week 28

Number of patients wiht abnormal changes from baseline in laboratory tests

Time Frame: Baseline, up to week 28

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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