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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01646424

First received: July 19, 2012

Last updated: October 15, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

October 15, 2012

Start Date ^ICMJE

August 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population. [ Time Frame: During 1 month, up to September 2012 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01646424 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Socio-demographics profile [ Time Frame: During 1 month, up to September 2012 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
Treatment-related information [ Time Frame: During 1 month, up to September 2012 ] [ Designated as safety issue: No ]
Date of first prescription for Turbuhaler; Concomitant treatments for COPD
Inhaler use [ Time Frame: During 1 month, up to September 2012 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Type of the hospital: state, university, private

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

446

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT01646424

Other Study ID Numbers ^ICMJE

NIS-RTR-XXX-2012/1

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Mujgan Ates, DR	AZ MC Turkey
Principal Investigator:	Akin Kaya, PROF.DR.	Ankara University Faculty of Medicine, Chest Diseases Department

Information Provided By

AstraZeneca

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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