N/A
N=154
Preference Tiotropium Respimat Study in COPD
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01810692 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) — 80.71; 79.92 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Group1:Spiriva® Respimat® (Device); Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) |
80.71; 79.92 | — |
| SECONDARY Total Performance PASAPQ Score. |
82.50; 78.20 | — |
| SECONDARY Total Convenience PASAPQ Score |
78.62; 81.93 | — |
| SECONDARY Overall Satisfaction Question |
5.96; 5.90 | — |
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
Eligibility Criteria
Inclusion criteria
- 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.
- 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
- Previously included in this study or currently participating in another interventional study.
- Visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire.
- Patients who are treated simultaneously with both respiratory medications (Spiriva® Respimat® and Hirobriz® Breezhaler® / Onbrez® Breezhaler® / Oslif® Breezhaler®).
Data sourced from ClinicalTrials.gov (NCT01810692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.