Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01036763
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.

Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).

Detailed Description

Study Design:

observational

Study Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Study Start: 2010-01
• Primary Completion: 2010-08
• Results First Submitted: 2012-02-15
• Results First Submitted QC: 2012-02-15
• Results First Posted: 2012-03-22
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of Treatment With Tiotropium According to Physician's Assessment	6 - 12 weeks	Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
Assessment of Efficacy According to Physician	6 - 12 weeks	Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Assessment of Tolerability According to Physician	6 - 12 weeks	Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Assessment of Efficacy According to Patient	6 - 12 weeks	patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Assessment of Tolerability According to Patient	6 - 12 weeks	Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

Secondary Outcome Measures

Name	Time	Method
Physician's Global Evaluation at Visit 1	0 weeks	Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.
Physician's Global Evaluation at Visit 2	after 6 - 12 weeks	Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.

Trial Locations

Locations (352)

Boehringer Ingelheim Investigational Site 1; 🇩🇪 Ahrensburg, Germany

Boehringer Ingelheim Investigational Site 2; 🇩🇪 Amberg, Germany

Boehringer Ingelheim Investigational Site 3; 🇩🇪 Arnstadt, Germany

Boehringer Ingelheim Investigational Site 4; 🇩🇪 Auerbach, Germany

Boehringer Ingelheim Investigational Site 10; 🇩🇪 Augsburg, Germany

Boehringer Ingelheim Investigational Site 5; 🇩🇪 Augsburg, Germany

Boehringer Ingelheim Investigational Site 6; 🇩🇪 Augsburg, Germany

Boehringer Ingelheim Investigational Site 7; 🇩🇪 Augsburg, Germany

Boehringer Ingelheim Investigational Site 8; 🇩🇪 Augsburg, Germany

Boehringer Ingelheim Investigational Site 9; 🇩🇪 Augsburg, Germany

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