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
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 446
Study Start Date: August 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646424

Locations
Turkey
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mujgan Ates, DR AZ MC Turkey
Principal Investigator: Akin Kaya, PROF.DR. Ankara University Faculty of Medicine, Chest Diseases Department
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01646424     History of Changes
Other Study ID Numbers: NIS-RTR-XXX-2012/1
Study First Received: July 19, 2012
Last Updated: October 15, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by AstraZeneca:
COPD,
Patient satisfaction,
fix combination,
NIS Turkey,
turbuhaler,
FSI-10

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014