Chronic Obstructive Pulmonary Disease (COPD)NCT01646424
Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 20 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 446 participants
- Where
- 20 sitesTurkey (Türkiye)
- Study dates
- Aug 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Turkey (Türkiye)20 sites
Research Site
Adana
Research Site
Afyonkarahisar
Research Site
Ankara
Research Site
Aydin
Research Site
Balıkesir
Research Site
Bartın
Research Site
Çankırı
Research Site
Elâzığ
Research Site
Gaziantep
Research Site
Istanbul
Research Site
Izmir
Research Site
Kayseri
Research Site
Kocaeli
Research Site
Konya
Research Site
Manisa
Research Site
Mersin
Research Site
Rize
Research Site
Sakarya
Research Site
Samsun
Research Site
Yozgat
About this study
Official title: 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.
Read the detailed description
Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD
- Keywords
- COPD,, Patient satisfaction,, fix combination,, NIS Turkey,, turbuhaler,, FSI-10
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 1 month, up to September 2012
Secondary outcomes (5)
Socio-demographics profile
Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied.
Measured: During 1 month, up to September 2012
Clinical characteristics
Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis
Measured: During 1 month, up to September 2012
Treatment-related information
Date of first prescription for Turbuhaler; Concomitant treatments for COPD
Measured: During 1 month, up to September 2012
Inhaler use
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.
Measured: During 1 month, up to September 2012
Site characteristics
Type of the hospital: state, university, private
Measured: During 1 month, up to September 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mujgan Ates, DR, Study director, AZ MC TurkeyAkin Kaya, PROF.DR., Principal investigator, Ankara University Faculty of Medicine, Chest Diseases Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646424
- Sponsor's protocol ID
- NIS-RTR-XXX-2012/1
- Status last verified
- Oct 2012
- First submitted
- 19 Jul 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD
- ClinicalTrials.gov ID
- NCT01646424
- Acronym / sponsor ID
- NIS-RTR-XXX-2012/1
- Keywords
- COPD,, Patient satisfaction,, fix combination,, NIS Turkey,, turbuhaler,, FSI-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Socio-demographics profile
Time frame: During 1 month, up to September 2012
Clinical characteristics
Time frame: During 1 month, up to September 2012
Treatment-related information
Time frame: During 1 month, up to September 2012
Inhaler use
Time frame: During 1 month, up to September 2012
Site characteristics
Time frame: During 1 month, up to September 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujgan Ates, DR study director
AZ MC Turkey
Akin Kaya, PROF.DR. principal investigator
Ankara University Faculty of Medicine, Chest Diseases Department
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 20 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population. (time frame: During 1 month, up to September 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.