Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation
| NCT number | NCT02172521 |
| Other study ID # | 205.320 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | June 20, 2014 |
| Last updated | June 20, 2014 |
| Start date | January 2006 |
- 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.
| Status | Completed |
| Enrollment | 1536 |
| Est. completion date | |
| Est. primary completion date | October 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Primary | 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) | No | |
| Primary | Change from baseline for assessment of physical functioning in every day life (PF-10) | At baseline (visit 1) and after 4 weeks (visit 2) | No |
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