Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00615992
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2008-04
• Results First Submitted: 2009-06-30
• Results First Submitted QC: 2009-11-17
• Results First Posted: 2009-12-24
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 754

Inclusion Criteria

• Patients with suspected chronic obstructive pulmonary disease (COPD)
• 3 or more positive answers in COPD questionnaire
• Age over 40 years

Exclusion Criteria

• Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
• Patient treated with Spiriva in the past year
• Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

Secondary Outcome Measures

Name	Time	Method
Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Global Assessment of Efficacy by Patient	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Tolerability by Patient	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Efficacy by Physician	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Tolerability by Physician	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇦🇹 Wolkersdorf, Austria