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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02172521

Enrollment

1536

Registered

2014-06-24

Start date

2006-01-31

Completion date

Unknown

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief 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.

Interventions

DRUGTiotropium bromide

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score	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	At baseline (visit 1) and after 4 weeks (visit 2)
Change from baseline for assessment of physical functioning in every day life (PF-10)	At baseline (visit 1) and after 4 weeks (visit 2)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026