Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed

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

• Registration Number: NCT02172482
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2003-10
• 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: 63127

Inclusion Criteria

• Men and women aged at least 40 years presenting with the symptoms of COPD

Exclusion Criteria

• Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptoms of COPD	Tiotropium bromide	Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms

Primary Outcome Measures

Name	Time	Method
Change from baseline in breathlessness when walking/climbing stairs	Baseline, after 4 weeks
Change from baseline in overall severity of the clinical picture	Baseline, after 4 weeks of treatment
Occurrence of Adverse Events	up to 4 weeks
Change from baseline in breathlessness on Physical exercise	Baseline, after 4 weeks
Change from baseline in breathlessness during housework	Baseline, after 4 weeks
Change from baseline in breathlessness during everyday activities	Baseline, after 4 weeks