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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

July 19, 2012
October 15, 2012
August 2012
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01646424 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Chronic Obstructive Pulmonary Disease (COPD)
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01646424
NIS-RTR-XXX-2012/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Mujgan Ates, DR AZ MC Turkey
Principal Investigator: Akin Kaya, PROF.DR. Ankara University Faculty of Medicine, Chest Diseases Department
AstraZeneca
October 2012

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