Fact CheckerSign in

NCT07052942RecruitingPhase 4

Individualizing Treatment for Asthma in Primary Care (Full Study)

Source: ClinicalTrials.gov · Last updated 29 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
3200 (estimated)
First submitted
30 Jun 2025
Start date
1 Aug 2025
Primary completion date
15 Nov 2029
Lead sponsor
DARTNet Institute
Diseases
Asthma
NCT number
NCT07052942

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 3200
  • From 1 Aug 2025 to the primary completion date, 15 Nov 2029
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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).

Other illness

  • 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);

Lab values

  • 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 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;

Other

  • 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);

Who the study is looking for

  • A clinical asthma diagnosis for at least 1 year;
  • 13-75 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;
  • Able to provide consent (adolescents: assent) in English or Spanish; (i.e., cognitively impaired individuals are deemed not to be able to provide consent and thus do not meet inclusion criteria.);
  • 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.

Age in the registry: 13 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Colorado-Denver
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
DARTNet Institute
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
University North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Atrium Health
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
University of Missouri
Coordinator of this site? Confirm its status
ColumbiaUnited StatesNot yet recruiting
JPS Health Network
Coordinator of this site? Confirm its status
Fort WorthUnited StatesNot yet recruiting
Kelsey Research Foundation
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
University of Kansas
Coordinator of this site? Confirm its status
Kansas CityUnited StatesNot yet recruiting
Rutgers, Robert Wood Johnson Medical School
Coordinator of this site? Confirm its status
New BrunswickUnited StatesRecruiting
Mt. Sinai School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
AdventHealth
Coordinator of this site? Confirm its status
OrlandoUnited StatesNot yet recruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesNot yet recruiting
Reliant Medical Group
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.