Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD
Verified date | October 2012 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 446 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Turkey | Research Site | Adana | |
Turkey | Research Site | Afyon | |
Turkey | Research Site | Ankara | |
Turkey | Research Site | Ayd?n | |
Turkey | Research Site | Balikesir | |
Turkey | Research Site | Bartin | |
Turkey | Research Site | Cankiri | |
Turkey | Research Site | Elazig | |
Turkey | Research Site | Gaziantep | |
Turkey | Research Site | Istanbul | |
Turkey | Research Site | Izmir | |
Turkey | Research Site | Kayseri | |
Turkey | Research Site | Kocaeli | |
Turkey | Research Site | Konya | |
Turkey | Research Site | Manisa | |
Turkey | Research Site | Mersin | |
Turkey | Research Site | Rize | |
Turkey | Research Site | Sakarya | |
Turkey | Research Site | Samsun | |
Turkey | Research Site | Yozgat |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Clinical characteristics | Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis | During 1 month, up to September 2012 | No |
Secondary | Treatment-related information | Date of first prescription for Turbuhaler; Concomitant treatments for COPD | During 1 month, up to September 2012 | No |
Secondary | 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 | No |
Secondary | Site characteristics | Type of the hospital: state, university, private | During 1 month, up to September 2012 | No |
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