Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-01 @ 1:25 PM
Study NCT ID:
NCT01644357
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a 12-month Pharmaceutical Care Program on Control of Severe 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010593', 'term': 'Pharmaceutical Services'}], 'ancestors': [{'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung function improvement', 'timeFrame': '12 months', 'description': 'Measured by spirometry'}, {'measure': 'Quality of life improvement', 'timeFrame': '12 months', 'description': 'Measured by Asthma Quality of Life questionnaire'}], 'primaryOutcomes': [{'measure': 'asthma control of symptoms', 'timeFrame': '12 months', 'description': 'Measured by Asthma Control Questionnaire and medical evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma.\n\nThe objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe/refractory asthma presenting other respiratory disease,\n* ≥ 18 years of age,\n* using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent)\n* FEV1\\<60%,\n* regular visitor of the pharmacy and the physicians.\n\nExclusion Criteria:\n\n* participation in other intervention study during this study,\n* living in other cities,\n* could not participate in all visits of the study'}, 'identificationModule': {'nctId': 'NCT01644357', 'briefTitle': 'Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': 'Effect of a 12-month Pharmaceutical Care Program on Severe Asthma Patient. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ATENFAR-PROAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Dispensing only', 'description': 'Non clinical pharmacists will dispense drugs to patients and usual care will be offered.'}, {'type': 'EXPERIMENTAL', 'label': 'Pharmaceutical care', 'description': 'Patients on experimental group will receive counseling and education on the asthma condition, medication and lifestyle issues. In all visits, the inhaler technique will be reviewed, adherence to treatment and drug related problems were checked. If necessary the patient will be referred to the respiratory specialist to change the medication or to prescribe dose adjustment. Pharmacists document their initial and monthly follow up encounters using a specified form.', 'interventionNames': ['Other: Pharmaceutical care']}], 'interventions': [{'name': 'Pharmaceutical care', 'type': 'OTHER', 'description': 'Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.', 'armGroupLabels': ['Pharmaceutical care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40060-330', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Program for Asthma Control (ProAR) of the Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Pablo M Santos, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Bahia'}, {'name': 'Álvaro A Cruz, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Bahia'}, {'name': 'Lúcia B Noblat, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Bahia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publish a paper in a cientific journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Pablo de Moura Santos', 'investigatorAffiliation': 'Federal University of Bahia'}}}}