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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Ba253BINEB

Group Type EXPERIMENTAL

Ba253BINEB

Intervention Type DRUG

Ba253MDI

Group Type ACTIVE_COMPARATOR

Ba253MDI

Intervention Type DRUG

Interventions

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Ba253MDI

Intervention Type DRUG

Ba253BINEB

Intervention Type DRUG

Other Intervention Names

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Tersigan® aerosol

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No