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

October 15, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • 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, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
Time Frame: 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.
During 1 month, up to September 2012

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographics profile
Time Frame: During 1 month, up to September 2012
Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied.
During 1 month, up to September 2012
Clinical characteristics
Time Frame: During 1 month, up to September 2012
Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
During 1 month, up to September 2012
Treatment-related information
Time Frame: During 1 month, up to September 2012
Date of first prescription for Turbuhaler; Concomitant treatments for COPD
During 1 month, up to September 2012
Inhaler use
Time Frame: 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.
During 1 month, up to September 2012
Site characteristics
Time Frame: During 1 month, up to September 2012
Type of the hospital: state, university, private
During 1 month, up to September 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 16, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RTR-XXX-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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