Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation

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

Total Enrollment

1536 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Brief Summary

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* Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
* Secondary objective was to obtain safety data regarding adverse events.

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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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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD and proven hyperinflation

Patients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram

Tiotropium bromide

Intervention Type DRUG

Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®

Interventions

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Tiotropium bromide

Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®

Intervention Type DRUG

Other Intervention Names

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Spiriva®

Eligibility Criteria

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Inclusion Criteria

* Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) \> = 120% as measured by body plethysmography
* Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.