Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
|ClinicalTrials.gov Identifier: NCT01646424|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : October 16, 2012
|Condition or disease|
|Chronic Obstructive Pulmonary Disease (COPD)|
|Study Type :||Observational|
|Actual Enrollment :||446 participants|
|Official Title:||Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD|
|Study Start Date :||August 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||September 2012|
- Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population. [ Time Frame: 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.
- Socio-demographics profile [ Time Frame: 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 [ Time Frame: During 1 month, up to September 2012 ]Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
- Treatment-related information [ Time Frame: During 1 month, up to September 2012 ]Date of first prescription for Turbuhaler; Concomitant treatments for COPD
- Inhaler use [ Time Frame: 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 [ Time Frame: During 1 month, up to September 2012 ]Type of the hospital: state, university, private
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646424
|Study Director:||Mujgan Ates, DR||AZ MC Turkey|
|Principal Investigator:||Akin Kaya, PROF.DR.||Ankara University Faculty of Medicine, Chest Diseases Department|