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

June 20, 2014 updated by: Boehringer Ingelheim

Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptoms of COPD
Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms
Drug: Tiotropium bromide
Tiotropium bromide18 micrograms (capsule with powder for inhalation)
Other Names:
  • Spiriva®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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