MedPath

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

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Registration Number
NCT02172495
Lead Sponsor
Boehringer Ingelheim
Brief Summary

Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4700
Inclusion Criteria
  • Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease
Read More
Exclusion Criteria
  • Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Symptoms of COPDTiotropium bromidePatients with symptoms of COPD receiving Tiotropium bromide 18 micrograms
Primary Outcome Measures
NameTimeMethod
Occurrence of Adverse Events4 weeks
Change from baseline in breathlessness when walking/climbing stairsBaseline, after 4 weeks
Change from baseline in overall severity of the clinical pictureBaseline, after 4 weeks
Change from baseline in breathlessness during everyday activitiesBaseline, after 4 weeks
Change from baseline in breathlessness on physical exerciseBaseline, after 4 weeks
Change from baseline in breathlessness during houseworkBaseline, after 4 weeks
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath