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Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00281567

Last Updated: 2013-11-01

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Brief Summary

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Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium

Intervention Type DRUG

Respimat SMI

Intervention Type DEVICE

HandiHaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD
* FEV1 \< 60% predicted
* FEV1 \< 70% of FVC
* Smoking history of 10 pack-years

Exclusion Criteria

* Significant other disease than COPD
* Recent history of MI (1 year or less)
* Cardiac arrhythmia requiring drug therapy
* History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
* Symptomatic prostatic hypertrophy or bladder neck obstruction
* Known narrow-angle glaucoma
* Abnormal baseline hematology, blood chemistry or urinalysis
* History of cancer within last 5 years
* Life-threatening pulmonary obstruction
* Cystic fibrosis or bronchiectasis
* Tuberculosis
* Pulmonary resection
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim KG

Locations

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Boehringer Ingelheim Investigational Site

Study Chairs Or Principal Investigators, , Belgium

Site Status

Boehringer Ingelheim Investigational Site

Study Chairs Or Principal Investigators, , Netherlands

Site Status

Countries

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Belgium Netherlands

Other Identifiers

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205.250

Identifier Type: -

Identifier Source: org_study_id