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

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

Official Title
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Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population. | 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. | During 1 month, up to September 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographics profile | Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied. | During 1 month, up to September 2012 | 
| Clinical characteristics | Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis | During 1 month, up to September 2012 | 
| Treatment-related information | Date of first prescription for Turbuhaler; Concomitant treatments for COPD | During 1 month, up to September 2012 | 
| Inhaler use | 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. | During 1 month, up to September 2012 | 
| Site characteristics | Type of the hospital: state, university, private | During 1 month, up to September 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD,, Patient satisfaction,, fix combination,, NIS Turkey,, turbuhaler,, FSI-10