protocolSection identificationModule nctId: NCT06272370, orgStudyIdInfo id: PLACER-2021C3-24737-IC, briefTitle: Individualizing Treatment for Asthma in Primary Care, acronym: iTREAT-PC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: DARTNet Institute, class: OTHER_GOV, collaborators name: Penn State University, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: University of Colorado, Denver, collaborators name: RAND, collaborators name: University of Washington, collaborators name: Rutgers University, collaborators name: University of North Carolina, collaborators name: Brigham and Women's Hospital, collaborators name: Reliant Medical Group, collaborators name: Kelsey Research Foundation, collaborators name: Wake Forest University Health Sciences, descriptionModule briefSummary: This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system., conditionsModule conditions: Asthma, conditions: Bronchial Diseases, conditions: Respiratory Tract Infections, conditions: Lung Diseases, Obstructive, conditions: Lung Diseases, conditions: Respiratory Hypersensitivity, conditions: Immune System Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: patient randomized trial of three different drug combinations, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Asthma Symptom Monitoring online tools, interventions name: Inhaled Steroids, interventions name: Azithromycin Pill, outcomesModule primaryOutcomes measure: The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids)., secondaryOutcomes measure: Asthma control as measured by the Asthma Control Test, secondaryOutcomes measure: Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire, secondaryOutcomes measure: Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DARTNet Insitute, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Brian K Manning, MPH, role: CONTACT, phone: 800-434-0278, phoneExt: 82, email: brian.manning@dartnet.info, contacts name: Joel Shields, MA, role: CONTACT, phone: 80004340278, phoneExt: 84, email: joel.shields@dartnet.info, contacts name: Michelle Hernandez, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kari Stephens, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: John Valenta, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Wisniveski, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lipika Samal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False