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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01646424
First received: July 19, 2012
Last updated: October 15, 2012
Last verified: October 2012
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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 |
|---|
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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) |
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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013