Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in 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

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.

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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

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