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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Tiotropium bromide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

Official title: Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score

Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale

Change from baseline for assessment of physical functioning in every day life (PF-10)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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. Exclusion Criteria:

- Patients who presenting the general and specific contraindications mentioned in the

Patient Information and Prescribing Information

Locations and Contacts

Additional Information

Starting date: January 2006
Last updated: June 20, 2014

Page last updated: August 23, 2015

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