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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646424
• Other study ID #: NIS-RTR-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: October 15, 2012
• Start date: August 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Turkey, 

Outcome

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