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

Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01646424

Enrollment

446

Registered

2012-07-20

Start date

2012-08-31

Completion date

2012-09-30

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD,, Patient satisfaction,, fix combination,, NIS Turkey,, turbuhaler,, FSI-10

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.	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.

Secondary

Measure	Time frame	Description
Socio-demographics profile	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	During 1 month, up to September 2012	Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
Treatment-related information	During 1 month, up to September 2012	Date of first prescription for Turbuhaler; Concomitant treatments for COPD
Inhaler use	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	During 1 month, up to September 2012	Type of the hospital: state, university, private

Countries

Turkey (Türkiye)

Outcome results