Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02182635 | Completed Phase 3

• 1 other identifier: 54.561
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

• Number of Patients with Adverse Events

  Up to 28 weeks

• Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)

  Baseline, up to week 28

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

  Baseline, up to week 28

• Number of patients wiht abnormal changes from baseline in laboratory tests

  Baseline, up to week 28

Secondary Outcomes (5)

• 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

• Patient's impression

  Week 28

• Physician's global evaluation (final improvement)

  Week 28

Study Arms (1)

Ba253BINEB

EXPERIMENTAL

Drug: Ba253BINEB

Interventions

Ba253BINEB DRUG

Ba253BINEB

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 1998
• Primary Completion: March 1, 1999
• Last Updated: July 11, 2014

Record last verified: 2014-07