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

NCT02182583 | Completed Phase 3

• 1 other identifier: 54.560
• Study Type: interventional
• Target: 163
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change in COPD daily symptom scores

  Baseline and up to 4 weeks after first drug administration

Secondary Outcomes (12)

• Change from baseline in times of cough

  Baseline, up to 4 weeks after first drug administration

• Change from baseline in peak expiratory flow rate (PEFR)

  Baseline, up to 4 weeks after first drug administration

• Number of Patients with Adverse Events

  Up to 4 weeks

• Number of patients with significant changes in vital sings (blood pressure, pulse rate)

  Baseline, week 4

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

  Baseline, week 4

Study Arms (2)

Ba253BINEB

EXPERIMENTAL

Drug: Ba253BINEB

Ba253MDI

ACTIVE COMPARATOR

Drug: Ba253MDI

Interventions

Ba253MDI DRUG

Also known as: Tersigan® aerosol

Ba253MDI

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 whose symptoms are stable and have at least 4 symptomatic days a week
• Patients with FEV1.0/FVC of \<= 70% in the screening test
• Patients aged \>= 40 years or older
• Patients must be able to inhale the study drug via BINEB and MDI
• Patients must be able to understand the patient information form

You may not qualify if:

• Those who correspond to the following shall be excluded from the subjects of study.
• Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
• Patients who are constantly administered oral steroid
• Patients with glaucoma
• Patients who have prostatic hypertrophy
• Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
• 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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: October 1, 1998
• Primary Completion: June 1, 2000
• Last Updated: July 11, 2014

Record last verified: 2014-07