Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
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|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|
|Actual Primary Completion Date :||September 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|