Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01646424
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of this study is to describe patient preferences on budesonide/formoterol fix dose combination for the treatment of their COPD, and to find those factors more strongly associated to a better attitude to medication.

Detailed Description

Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD

Study Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-20
• Study Start: 2012-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Provision of subject informed consent and to be an outpatient
• Clinical diagnosis of COPD according to ICD-10 classification, females and males, aged ≥ 40 years
• To be prescribed a fixed dose combination of inhaled budesonide/formoterol fix combination at least 3 months before the study start

Exclusion Criteria

• Pregnancy for women
• Use of inhaled medication via a metered dose inhaler (pMDI)
• Currently participating in randomized clinical trials and being included in this study once

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.	During 1 month, up to September 2012	The FSI-10 is a self-completed 10-item questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled medications. Each of the 10 items has 5 response options from poorer to greater ease of use, scored 1 to 5, respectively. The minimum score is 10 whereas the maximum is 50.

Secondary Outcome Measures

Name	Time	Method
Socio-demographics profile	During 1 month, up to September 2012	Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied.
Clinical characteristics	During 1 month, up to September 2012	Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
Treatment-related information	During 1 month, up to September 2012	Date of first prescription for Turbuhaler; Concomitant treatments for COPD
Inhaler use	During 1 month, up to September 2012	Specifically for evaluating real-life patterns of use and usage knowledge of the dry-powder inhaler (Turbuhaler) that delivers budesonide / formoterol fix combination, a specific checklist of the key features of the inhalation technique.Preference with the inhaler she/he is using will be assessed based on patient reported outcomes.
Site characteristics	During 1 month, up to September 2012	Type of the hospital: state, university, private

Trial Locations

Locations (1)

Research Site; 🇹🇷 Yozgat, Turkey