SKIRON: Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice
Study Details
Study Description
Brief Summary
The greater efficacy of combination therapy led to the development of fixed combination devices which simultaneously carry both glucocorticosteroid and a LABA (eg stable combinations of fluticasone-salmeterol, budesonide-formoterol).
Fixed combinations are easier to use for patients, potentially increasing compliance, and ensure that the LABA always accompanied by glycocorticosteroeides1. From the available combinations of the combination of budesonide-formoterol can be used both in maintenance therapy and for the relief of symptoms due to the rapid onset of action of formoterol compared with salmeterol. Both components of budesonide-formoterol combination when administered on demand contribute to strengthening protection from severe exacerbations in patients receiving combination therapy for maintenance, and enable improvement of asthma control at relatively low doses of ICS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This prospective observational study of the Greek population to approximately 2,500 patients suffering from asthma, aims to collect the characteristics of patients that were selected to obtain an inhaled combination of budesonide and formoterol fumarate dihydrate in any of portions 100 / 6mcg, 200 / 6mcg, 400/12 mcg (Pulmoton®), and to collect data on the quality of life to such an inhaled combination through Elpenhaler® device.
Data will be collected for a period of three months from patients diagnosed with asthma not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Data will be collected during the period of one (1) to three (3) months (± 2 weeks) from the initiation of treatment with inhaled combination include ACQ checklist questionnaire mini AQLQ, questionnaire FSI 10, and data any existing comorbidities.
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy (ACQ score) [3 months]
ACQ score
Secondary Outcome Measures
- Quality of Life (AQLQ score) [3 months]
AQLQ score
- Patient Satisfaction (FS1 -10 score) [3 months]
FS1 -10 score
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men or women patients with asthma over 18 years
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Compliant to treatment
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Compliant to the study procedures
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Signed consent form after written study information
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Patients with Asthma to start treatment with the inhaled combination of budesonide / formoterol at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through Elpenhaler® device may be included in the study. Under current SPC, the drug Pulmoton® indicated in the regular treatment of asthma, wherein the administration of the combination (inhaled corticosteroid and long-action beta2-agonist) is appropriate, namely in patients:
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patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting or
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already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists Note: Pulmoton® 100/6 micrograms / dose is not suitable for patients with severe asthma.
Exclusion Criteria:
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Men or women with Asthma patients under 18 years
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Non-compliance to treatment
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Non-compliance to study procedures
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Do not signed patient consent
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Incorrect use of inhaled therapies
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Patients with COPD (any stage)
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Patients already receiving any combination ICS / LABA at entry into the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 7th Pulmonary Dept, Athens Chest Hospital | Athens | Mesogion Ave. 152 | Greece | Athens 11527 |
Sponsors and Collaborators
- Elpen Pharmaceutical Co. Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-HAL-EL-70