Preference Tiotropium Respimat Study in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810692
• Other study ID #: 205.514
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 16, 2015
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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

Description:

Purpose:

Study Design:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the study and conducting any study procedures.

2. Adult male or female patients with chronic obstructive pulmonary disease (COPD) for less than a year who follow usual clinical practice of the participant sites and who are on treatment with Spiriva® Respimat®, Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler® for at least of 3 months but not more than maximum of 6 months before the informed consent date.

Exclusion criteria:

1. Previously included in this study or currently participating in another interventional study.

2. Visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire.

3. Patients who are treated simultaneously with both respiratory medications (Spiriva® Respimat® and Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler®).

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Group1:Spiriva® Respimat®
COPD patients using Respimat®
• Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®
COPD patients using Breezhaler®®

Locations

Country	Name	City	State
Spain	Boehringer Ingelheim Investigational Site 13	A Coruña
Spain	Boehringer Ingelheim Investigational Site 5	Barcelona
Spain	Boehringer Ingelheim Investigational Site 6	Barcelona
Spain	Boehringer Ingelheim Investigational Site 8	Barcelona
Spain	Boehringer Ingelheim Investigational Site 12	Burgos
Spain	Boehringer Ingelheim Investigational Site 14	Galdako.
Spain	Boehringer Ingelheim Investigational Site 11	Laredo
Spain	Boehringer Ingelheim Investigational Site 1	Málaga
Spain	Boehringer Ingelheim Investigational Site 3	Mérida
Spain	Boehringer Ingelheim Investigational Site 15	Palma de Mallorca.
Spain	Boehringer Ingelheim Investigational Site 9	Pozuelo de Alarcón
Spain	Boehringer Ingelheim Investigational Site 7	Sabadell
Spain	Boehringer Ingelheim Investigational Site 2	Sevilla
Spain	Boehringer Ingelheim Investigational Site 10	Torrelodones
Spain	Boehringer Ingelheim Investigational Site 4	Villanueva de la Serena

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)	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.	day 1	No
Secondary	Total Performance PASAPQ Score.	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.	day 1	No
Secondary	Total Convenience PASAPQ Score	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.	day 1	No
Secondary	Overall Satisfaction Question	The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.	day 1	No

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