Individualizing Treatment for Asthma in Primary Care

Completed · Phase 4

Conditions studied: Asthma, Bronchial Diseases, Respiratory Tract Infections, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Immune System Diseases

In brief

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.

Key facts

Study ID

NCT06272370

Run by

DARTNet Institute

People needed

103

Starts

2024-02-01

Expected to finish

2024-12-31

Last updated by the study team

2025-04-20

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical asthma diagnosis for at least 1 year;
• 12-75 years of age;
• A current ACT total score of <20 OR an exacerbation requiring 72 hours or more of parenteral 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.

You may not qualify if…

• 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;
• 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 torsades de pointes);
• On daily or every other day oral steroids for any reason;
• Currently on R-ICS or AZ therapy. 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.
• 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) or possible risk (i.e., can cause prolonged QT but lacks evidence for risk of torsades de pointes when taken as recommended) - Full lists in Appendix 1.
• 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).

Where it is running

• DARTNet Insitute — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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