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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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