Preference Tiotropium Respimat Study in COPD

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Group1:Spiriva® Respimat®; Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®

Study type: Observational

Funder types: Industry

Identifiers

NCT01810692

205.514

Details and patient eligibility

About

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

Full description

Purpose:

Study Design:

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®).

Trial design

150 participants in 2 patient groups

Group 1

Treatment:

Device: Group1:Spiriva® Respimat®

Group 2

Treatment:

Device: Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®