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

Boehringer Ingelheim1,536 enrolled

Overview

* 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.

Study Type

OBSERVATIONAL

Enrollment

1,536

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium bromideDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.