Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02182635

Last Updated: 2014-07-11

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Brief Summary

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The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ba253BINEB

Group Type EXPERIMENTAL

Ba253BINEB

Intervention Type DRUG

Interventions

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Ba253BINEB

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients with FEV1.0/FVC (Forced vital capacity) of \<= 70% in the screening test and whose symptoms are stable
2. Patients aged \>= 40 years or older
3. Patients must be able to understand the patient information form

Exclusion Criteria

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
4. Patients with glaucoma
5. Patients who have prostatic hypertrophy
6. Patients with hypersensitivity to anticholinergic drugs
7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
8. Women who are pregnant or who may become pregnant, or nursing women
9. 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

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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54.561

Identifier Type: -

Identifier Source: org_study_id

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