Clinical trial NCT01810692: Preference Tiotropium Respimat Study in COPD
Official title: Cross-sectional Study to Assess the Handling , Patient Satisfaction, and Preference for Inhalation Devices in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: COPD

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:

Eligibility criteria: 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®).

Primary outcomes:
measure: Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)
timeFrame: day 1
Secondary outcomes:
measure: Total Performance PASAPQ Score.
timeFrame: day 1
measure: Total Convenience PASAPQ Score
timeFrame: day 1
measure: Overall Satisfaction Question
timeFrame: day 1
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Boehringer Ingelheim Investigational Site 13
city: Barcelona
country: Spain
facility: Boehringer Ingelheim Investigational Site 5
city: Barcelona
country: Spain
facility: Boehringer Ingelheim Investigational Site 6
city: Barcelona
country: Spain
facility: Boehringer Ingelheim Investigational Site 8
city: Burgos
country: Spain
facility: Boehringer Ingelheim Investigational Site 12
city: Galdako.
country: Spain
facility: Boehringer Ingelheim Investigational Site 14
city: Laredo
country: Spain
facility: Boehringer Ingelheim Investigational Site 11
city: Málaga
country: Spain
facility: Boehringer Ingelheim Investigational Site 1
city: Mérida
country: Spain
facility: Boehringer Ingelheim Investigational Site 3
city: Palma de Mallorca.
country: Spain
facility: Boehringer Ingelheim Investigational Site 15
city: Pozuelo de Alarcón
country: Spain
facility: Boehringer Ingelheim Investigational Site 9
city: Sabadell
country: Spain
facility: Boehringer Ingelheim Investigational Site 7
city: Sevilla
country: Spain
facility: Boehringer Ingelheim Investigational Site 2
city: Torrelodones
country: Spain
facility: Boehringer Ingelheim Investigational Site 10
city: Villanueva de la Serena
country: Spain
facility: Boehringer Ingelheim Investigational Site 4
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: