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) scoreChange 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
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