Preference Tiotropium Respimat Study in COPD

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01810692
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

In COPD the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for COPD. This is a cross-sectional study where satisfaction, preference and handling of two different devices such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD patients

Detailed Description

Purpose:

Study Design:

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Results First Submitted: 2015-03-16
• Results First Submitted QC: 2015-03-16
• Last Update Submitted: 2015-03-16
• Results First Posted: 2015-03-26
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)	day 1	Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.

Secondary Outcome Measures

Name	Time	Method
Total Performance PASAPQ Score.	day 1	All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
Total Convenience PASAPQ Score	day 1	All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.
Overall Satisfaction Question	day 1	The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.

Trial Locations

Locations (15)

Boehringer Ingelheim Investigational Site 13; 🇪🇸 A Coruña, Spain

Boehringer Ingelheim Investigational Site 5; 🇪🇸 Barcelona, Spain

Boehringer Ingelheim Investigational Site 8; 🇪🇸 Barcelona, Spain

Boehringer Ingelheim Investigational Site 14; 🇪🇸 Galdako., Spain

Boehringer Ingelheim Investigational Site 6; 🇪🇸 Barcelona, Spain

Boehringer Ingelheim Investigational Site 12; 🇪🇸 Burgos, Spain

Boehringer Ingelheim Investigational Site 11; 🇪🇸 Laredo, Spain

Boehringer Ingelheim Investigational Site 1; 🇪🇸 Málaga, Spain

Boehringer Ingelheim Investigational Site 15; 🇪🇸 Palma de Mallorca., Spain

Boehringer Ingelheim Investigational Site 7; 🇪🇸 Sabadell, Spain

Boehringer Ingelheim Investigational Site 3; 🇪🇸 Mérida, Spain

Boehringer Ingelheim Investigational Site 2; 🇪🇸 Sevilla, Spain

Boehringer Ingelheim Investigational Site 4; 🇪🇸 Villanueva de la Serena, Spain

Boehringer Ingelheim Investigational Site 10; 🇪🇸 Torrelodones, Spain

Boehringer Ingelheim Investigational Site 9; 🇪🇸 Pozuelo de Alarcón, Spain