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Completed

NCT Number: NCT01646424

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Behavior Chronic Disease Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Adana, Turkey (Türkiye)

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Clinical characteristics

    Time frame: During 1 month, up to September 2012

    Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis

  3. Treatment-related information

    Time frame: During 1 month, up to September 2012

    Date of first prescription for Turbuhaler; Concomitant treatments for COPD

  4. 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.

  5. Site characteristics

    Time frame: During 1 month, up to September 2012

    Type of the hospital: state, university, private

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2012
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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