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

* 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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium Bromide

Drug

Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®

Other names: Spiriva®

Primary outcomes

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

Time frame: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale

Time frame: At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of physical functioning in every day life (PF-10)

Time frame: At baseline (visit 1) and after 4 weeks (visit 2)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
First posted: Jun 24, 2014
Registry last updated: Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed