Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT02983994
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of inhaler management.', 'timeFrame': 'two months', 'description': 'The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma, devices'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. Finally, we also want to study the degree of patient satisfaction with each of the inhalers studied'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as asthma with indication for treatment with an inhaled steroid (IC) and long-acting beta agonist (LABA), over 18 years of age, will be consecutively included according to the criteria of the GINA 2015 (Global Strategy for Asthma Management and Prevention), who have never used dry-powder inhalers, and whose doctor has prescribed one of the inhalation systems to be studied in the normal practice of the consultation. Patients will be recruited consecutively to complete the sample size established with each type of device, in each of the participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device.\n* Over 18 years.\n* Patient in stable phase without having had exacerbations in the 3 months previous to the Inclusion in the study\n\nExclusion Criteria:\n\n* Presence of relevant respiratory disease other than asthma (including COPD).\n* Refusal to participate in the study and sign informed consent or inability to To give informed consent.\n* Patients who have previously been treated with inhaled dust devices dry.'}, 'identificationModule': {'nctId': 'NCT02983994', 'briefTitle': 'Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Andalusian Network for Design and Translation of Advanced Therapies'}, 'officialTitle': 'Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma', 'orgStudyIdInfo': {'id': 'FPS-INH-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with asthma with an inhaled steroid', 'description': 'Patients with a diagnosis of asthma with indication of Treatment with an inhaled steroid (CI)', 'interventionNames': ['Device: TURBUHALER®']}, {'label': 'Patients with asthma with an inhaled Beta agonist', 'description': 'Patients with a diagnosis of asthma with indication of Treatment with an inhaled Beta agonist (LABA)', 'interventionNames': ['Device: SPIROMAX®']}], 'interventions': [{'name': 'TURBUHALER®', 'type': 'DEVICE', 'armGroupLabels': ['Patients with asthma with an inhaled steroid']}, {'name': 'SPIROMAX®', 'type': 'DEVICE', 'armGroupLabels': ['Patients with asthma with an inhaled Beta agonist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41092', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza Progreso y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}