Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice (SKIRON)
|ClinicalTrials.gov Identifier: NCT03055793|
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : September 7, 2017
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|
|Asthma Quality of Life Satisfaction||Other: budesonide formoterol fixed combination|
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 Type :||Observational|
|Actual Enrollment :||1400 participants|
|Official Title:||A Real Life, on International, Multicenter Study to Assess the Efficacy and Quality of Life in Greek Asthmatic Patients Who Will be on Fixed Dose Bodesonide Formoterol Combination Treatment|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
- Other: budesonide formoterol fixed combination
Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.
- Efficacy (ACQ score) [ Time Frame: 3 months ]ACQ score
- Quality of Life (AQLQ score) [ Time Frame: 3 months ]AQLQ score
- Patient Satisfaction (FS1 -10 score) [ Time Frame: 3 months ]FS1 -10 score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055793
|7th Pulmonary Dept, Athens Chest Hospital|
|Athens, Mesogion Ave. 152, Greece, Athens 11527|