Preference Tiotropium Respimat Study in COPD

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Group1:Spiriva® Respimat®; Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

Detailed Description

Purpose:

Study Design:

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COPD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Device: Group1:Spiriva® Respimat®; COPD patients using Respimat®
Group 2	Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®; COPD patients using Breezhaler®®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall Satisfaction Question	The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.	day 1

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (ESTIMATE): March 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 205.514