Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-24 @ 8:47 AM
Study NCT ID:
NCT03055793
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2017-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy (ACQ score)', 'timeFrame': '3 months', 'description': 'ACQ score'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (AQLQ score)', 'timeFrame': '3 months', 'description': 'AQLQ score'}, {'measure': 'Patient Satisfaction (FS1 -10 score)', 'timeFrame': '3 months', 'description': 'FS1 -10 score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Quality of Life', 'Satisfaction']}, 'descriptionModule': {'briefSummary': '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).\n\nFixed 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.', 'detailedDescription': "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.\n\nData 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asthmatic patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women patients with asthma over 18 years\n* Compliant to treatment\n* Compliant to the study procedures\n* Signed consent form after written study information\n* 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:\n* patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting or\n* 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.\n\nExclusion Criteria:\n\n* Men or women with Asthma patients under 18 years\n* Non-compliance to treatment\n* Non-compliance to study procedures\n* Do not signed patient consent\n* Incorrect use of inhaled therapies\n* Patients with COPD (any stage)\n* Patients already receiving any combination ICS / LABA at entry into the study"}, 'identificationModule': {'nctId': 'NCT03055793', 'acronym': 'SKIRON', 'briefTitle': 'Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elpen Pharmaceutical Co. Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2017-HAL-EL-70'}}, 'armsInterventionsModule': {'interventions': [{'name': 'budesonide formoterol fixed combination', 'type': 'OTHER', 'description': 'Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Athens 11527', 'city': 'Athens', 'state': 'Mesogion Ave. 152', 'country': 'Greece', 'facility': '7th Pulmonary Dept, Athens Chest Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elpen Pharmaceutical Co. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}