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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium bromide

• Registration Number: NCT02172521
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1536

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.

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Exclusion Criteria

• Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing Information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD and proven hyperinflation	Tiotropium bromide	Patients with COPD and proven hyperinflation receiving tiotropium bromide 18 microgram

Primary Outcome Measures

Name	Time	Method
Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale	At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score	At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of physical functioning in every day life (PF-10)	At baseline (visit 1) and after 4 weeks (visit 2)