Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
observational
446
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedOctober 16, 2012
October 1, 2012
1 month
July 19, 2012
October 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
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 Outcomes (5)
Socio-demographics profile
During 1 month, up to September 2012
Clinical characteristics
During 1 month, up to September 2012
Treatment-related information
During 1 month, up to September 2012
Inhaler use
During 1 month, up to September 2012
Site characteristics
During 1 month, up to September 2012
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Adana, Turkey (Türkiye)
Research Site
Afyonkarahisar, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ayd?n, Turkey (Türkiye)
Research Site
Balıkesir, Turkey (Türkiye)
Research Site
Bartın, Turkey (Türkiye)
Research Site
Çankırı, Turkey (Türkiye)
Research Site
Elâzığ, Turkey (Türkiye)
Research Site
Gaziantep, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Kayseri, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Konya, Turkey (Türkiye)
Research Site
Manisa, Turkey (Türkiye)
Research Site
Mersin, Turkey (Türkiye)
Research Site
Rize, Turkey (Türkiye)
Research Site
Sakarya, Turkey (Türkiye)
Research Site
Samsun, Turkey (Türkiye)
Research Site
Yozgat, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mujgan Ates, DR
AZ MC Turkey
- PRINCIPAL INVESTIGATOR
Akin Kaya, PROF.DR.
Ankara University Faculty of Medicine, Chest Diseases Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2012
First Posted
July 20, 2012
Study Start
August 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
October 16, 2012
Record last verified: 2012-10