Clinical trial NCT01646424: Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD,
Patient satisfaction,
fix combination,
NIS Turkey,
turbuhaler,
FSI-10
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 446
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes ≥ 40 years of age, diagnosed with COPD (according to ICD-10 criteria) and receiving budesonide/formoterol fix dose combination treatment by means of inhaler devices. The first prescription must be given at least 3 months prior to the study start and patient inclusion.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
timeFrame: During 1 month, up to September 2012
Secondary outcomes:
measure: Socio-demographics profile
timeFrame: During 1 month, up to September 2012
measure: Clinical characteristics
timeFrame: During 1 month, up to September 2012
measure: Treatment-related information
timeFrame: During 1 month, up to September 2012
measure: Inhaler use
timeFrame: During 1 month, up to September 2012
measure: Site characteristics
timeFrame: During 1 month, up to September 2012
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Research Site
city: Afyon
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ayd?n
country: Turkey
facility: Research Site
city: Balikesir
country: Turkey
facility: Research Site
city: Bartin
country: Turkey
facility: Research Site
city: Cankiri
country: Turkey
facility: Research Site
city: Elazig
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Rize
country: Turkey
facility: Research Site
city: Sakarya
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Yozgat
country: Turkey
facility: Research Site
Study officials:
affiliation: AZ MC Turkey
name: Mujgan Ates, DR
role: STUDY_DIRECTOR
affiliation: Ankara University Faculty of Medicine, Chest Diseases Department
name: Akin Kaya, PROF.DR.
role: PRINCIPAL_INVESTIGATOR
References: