NCT07052942 · DARTNet Institute
Individualizing Treatment for Asthma in Primary Care (Full Study)
(iTREAT-PC)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Inhaled corticosteroid (ICS)
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.
DRUG
Azithromycin
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.
OTHER
Asthma Symptom Monitoring Web-based Application
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).
Primary outcome measures
Rate of Asthma Exacerbations Per Year
Time frame: Follow-up is up to 16 months.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A clinical asthma diagnosis for at least 1 year; 2. 13-75 years of age; 3. 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; 4. 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; 5. 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.); 6. 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. 7. Patients on medi
Where
- Aurora, Colorado
- Orlando, Florida
- Kansas City, Kansas
- Worcester, Massachusetts
- Columbia, Missouri
- New Brunswick, New Jersey
- New York, New York
- Chapel Hill, North Carolina
- Charlotte, North Carolina
- Fort Worth, Texas
- Houston, Texas
- Seattle, Washington
Collaborators
Penn State University, Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, RAND, University of Washington, University of North Carolina, Reliant Medical Group, Kelsey Research Foundation, University of Kansas, University of Missouri-Columbia, John Peter Smith Health Network, Rutgers University, AdventHealth, Wake Forest University Health Sciences
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations