N/A
Completed N=154
Preference Tiotropium Respimat Study in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01810692 ↗
Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) — 80.71; 79.92 units on a scale
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
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 | — |
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. Informational only — not medical advice.