Phase 4
N=103
Individualizing Treatment for Asthma in Primary Care
Asthma · Bronchial Diseases · Respiratory Tract Infections · Lung Diseases, Obstructive · Lung Diseases
Bottom Line
View on ClinicalTrials.gov: NCT06272370 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Asthma Control as Measured by the Asthma Control Test (ACT) — 18.77; 18.96; 20.45; 20.14 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Asthma Symptom Monitoring online tools (Other); Inhaled Steroids (Drug); Azithromycin Pill (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- DARTNet Institute
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control as Measured by the Asthma Control Test (ACT) |
18.77; 18.96; 20.45; 20.14 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) as Measured by the Juniper Mini Asthma Quality of Life Questionnaire |
5.25; 5.3; 5.59; 5.27 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- A clinical asthma diagnosis for at least 1 year;
- 12-75 years of age;
- A current ACT total score of 30 days and 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).
Data sourced from ClinicalTrials.gov (NCT06272370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.