Individualizing Treatment for Asthma in Primary Care (Full Study)
iTREAT-PC
1 other identifier
interventional
3,200
1 country
13
Brief Summary
While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Aug 2025
Longer than P75 for phase_4 asthma
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 8, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2029
October 29, 2025
October 1, 2025
4.3 years
June 30, 2025
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Asthma Exacerbations Per Year
The primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year, monthly through study completion.
Follow-up is up to 16 months.
Secondary Outcomes (3)
Asthma Control as Measured by the Asthma Control Test (ACT)
Follow-up is up to 16 months.
Asthma Quality of Life Questionnaire (AQLQ) as Measured by the Juniper Mini Asthma Quality of Life Questionnaire
Follow-up is up to 16 months.
Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma
Follow-up is up to 16 months.
Study Arms (4)
Inhaled corticosteroids as part of rescue therapy (R-ICS)
ACTIVE COMPARATORMaintenance And Reliever Therapy (MART), or Patient Activated Reliever Triggered Inhaled Corticosteroids (PARTICS) - this includes budesonide-albuterol (AirSupra)
Azithromycin (AZ)
ACTIVE COMPARATORAzithromycin - 500mg three times per week. Can be reduced to 250 mg three times per week for side effects.
Enhanced Usual Care
OTHERParticipants will be asked to use an online Asthma Symptom Monitoring (ASM) tool to enhance communication with the medical team as well as self-awareness of their asthma symptoms. There are no "study drugs" in this intervention.
Inhaled corticosteroids as part of rescue therapy (R-ICS) + Azithromycin
ACTIVE COMPARATORR-ICS either as MART therapy or PARTICS + Azithromycin
Interventions
Participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid (beclomethasone, budesonide, fluticasone, mometasone, ciclesodine) of their choice with their current reliever therapy or be converted to budesonide/albuterol as rescue therapy.
Participants will take 500mg of azithromycin three times a week or 10mg/kg if under 50Kg which may be reduced to 250mg/Kg for side effects.
All participants will be provided access to the Asthma Symptom Monitoring (ASM) tools. ASM can be integrated with electronic health records (EHR) or used as a stand alone application. Participants will answer 5 questions about their asthma each week. If symptoms are problematic, participants can request a call back from a person on their care team. Participants can view a graph of their data, watch videos, and record peak flows. Clinicians and members of the care team can view data in the EHR (not for stand alone web app).
Eligibility Criteria
You may qualify if:
- A clinical asthma diagnosis for at least 1 year;
- years of age;
- A prescription for an ICS either used regularly, or on an as needed controller, not reliever, schedule - ICS or ICS + LABA or ICS+LABA+LAMA;
- A current ACT total score of \<20 OR an exacerbation requiring 72 hours or more of systemic steroids or a hospitalization of at least 24 hours \> 30 days and \< 365 days prior to enrollment;
- Patients with a coexisting clinical diagnosis of COPD are eligible if they meet any one of the following criteria:
- (i) Never smoker without secondary lung disease causing airway obstruction. (ii) Current or former smoker with obstruction on PFTs, but normal diffusing capacity of the lungs for carbon monoxide (DLCO) in the past 24 months.
- Patients on medications that may interact with azithromycin but are not totally excluded may be enrolled if they agree to a cardiac rhythm strip after consent and prior to randomization (or have an ECG within the prior 24 months as a baseline assessment) and a repeat rhythm strip after one week if randomized to one of the azithromycin arms of the study.
You may not qualify if:
- Another family member living in the same household already enrolled in study;
- Life expectancy \<1 year (operationalized by the question to the patient's asthma care clinician "Would you be surprised if this person died in the next 12 months? If yes - include, if no - exclude);
- No ICS prescribed for the individual (does not have to be using the ICS inhaler);
- Active treatment for hematological or solid organ cancer other than basal cell or skin squamous cell cancer (if participant is \> 12 months out from original therapy and may be on a cancer maintenance drug that is not otherwise contraindicated they are eligible for the study);
- Allergy to macrolides or conditions for which macrolide administration may possibly be hazardous (e.g., acute or chronic hepatitis, cirrhosis, or other liver disease; end-stage renal disease; uncorrected hypokalemia or hypomagnesemia; clinically significant bradycardia; or history of prolonged cardiac repolarization and QT interval or evidence of prolonged cardiac repolarization on rhythm strip and QT interval or torsades de pointes);
- On daily or every other day oral steroids for any reason;
- A course of systemic steroids for an asthma exacerbation or an overnight hospitalization for an asthma exacerbation in the past month (can wait and re-check eligibility after one month);
- Currently on R-ICS or any antibiotic therapy expected to last more than 30 days. If on antibiotics less than 30 days, individual can enroll after they have stopped their current antibiotic for 72 hours. Individuals on biologics can be enrolled if they have been on a stable dose for \> 6 months and meet the ACT or exacerbation criteria as well as all other criteria after being on the stable does of the biologic.
- On a medication with known risk (i.e., that is associated with prolonged QT and associated with torsades de pointes even when taken as recommended)- absolute contraindication to eligibility- Full lists in Appendix B;
- Specified medications for which close monitoring has been recommended in the setting of macrolide administration (digoxin, warfarin, theophylline, ergotamine or dihydroergotamine, cyclosporine, hexobarbital, phenytoin or nelfinavir).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DARTNet Institutelead
- Penn State Universitycollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- University of Colorado, Denvercollaborator
- RANDcollaborator
- University of Washingtoncollaborator
- University of North Carolinacollaborator
- Reliant Medical Groupcollaborator
- Kelsey Research Foundationcollaborator
- University of Kansascollaborator
- University of Missouri-Columbiacollaborator
- John Peter Smith Health Networkcollaborator
- Rutgers Universitycollaborator
- AdventHealthcollaborator
- Wake Forest University Health Sciencescollaborator
Study Sites (13)
DARTNet Institute
Aurora, Colorado, 80045, United States
University Colorado-Denver
Aurora, Colorado, 80045, United States
AdventHealth
Orlando, Florida, 32803, United States
University of Kansas
Kansas City, Kansas, 66160, United States
Reliant Medical Group
Worcester, Massachusetts, 01608, United States
University of Missouri
Columbia, Missouri, 65211, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
University North Carolina
Chapel Hill, North Carolina, 27599, United States
Atrium Health
Charlotte, North Carolina, 28207, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Kelsey Research Foundation
Houston, Texas, 77005, United States
University of Washington
Seattle, Washington, 98105, United States
Related Publications (5)
Global Initiative for Asthma. Global strategy for asthma management and prevention 2023 report. Accessed February 10, 2024. https://ginasthma.org/2023-gina-main-report/
BACKGROUNDCalmes D, Huynen P, Paulus V, Henket M, Guissard F, Moermans C, Louis R, Schleich F. Chronic infection with Chlamydia pneumoniae in asthma: a type-2 low infection related phenotype. Respir Res. 2021 Feb 26;22(1):72. doi: 10.1186/s12931-021-01635-w.
PMID: 33637072BACKGROUNDWenzel SE. Severe Adult Asthmas: Integrating Clinical Features, Biology, and Therapeutics to Improve Outcomes. Am J Respir Crit Care Med. 2021 Apr 1;203(7):809-821. doi: 10.1164/rccm.202009-3631CI.
PMID: 33326352BACKGROUNDRay A, Camiolo M, Fitzpatrick A, Gauthier M, Wenzel SE. Are We Meeting the Promise of Endotypes and Precision Medicine in Asthma? Physiol Rev. 2020 Jul 1;100(3):983-1017. doi: 10.1152/physrev.00023.2019. Epub 2020 Jan 9.
PMID: 31917651BACKGROUNDIsrael E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26.
PMID: 35213105BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilson D Pace, MD, FAAFP
DARTNet Institute
- PRINCIPAL INVESTIGATOR
Dave Mauger, PhD
Penn State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 8, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
November 15, 2029
Study Completion (Estimated)
November 15, 2029
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Anticipated date is no later than 6/31/31.
- Access Criteria
- Users interested in obtaining study data will need to complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.
Analyzable data set will be submitted to PCORI at the conclusion of the study. This will include the final cleaned and locked data set that contains all the data used in conducting the analyses reported in the PCORI Final Research Report and is de-identified in accordance with the HIPAA Privacy. Rule (45 C.F.R. § 164.514(b)).