Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Spiriva

• Registration Number: NCT02172547
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-01
• 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: 10821

Inclusion Criteria

• Patients with COPD
• Smoker at start

Exclusion Criteria

• Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients who stopped smoking during treatment	Spiriva	-

Primary Outcome Measures

Name	Time	Method
Changes in health related quality of life	6 weeks

Secondary Outcome Measures

Name	Time	Method
Occurrence of Adverse events	6 weeks