Trial intelligence / Profile preview

iTREAT-PC: Individualizing Asthma Treatment

NCT07052942Phase 4

Key facts

Status: Recruiting
Start: Aug 2025
Primary completion: Nov 2029
Countries: 1
Sponsor: DARTNet Institute
Modality: Small Molecules

Drugs: azithromycin
Conditions: asthma

Overview

Phase 4, randomised, open-label trial of azithromycin in asthma (4 arms), sponsored by DARTNet Institute. Primary endpoint: Rate of Asthma Exacerbations Per Year at 16 months. Started Aug 2025; status: recruiting.

Design

4 arms

Study design: RandomizedOpen-label

R-ICS
Inhaled corticosteroids as part of rescue therapy
Azithromycin
Azithromycin 500mg 3x/week
Control
Enhanced Usual Care
R-ICS + Azithromycin
Combination of R-ICS and Azithromycin

Who it enrols

Patients aged 13-75 with a clinical asthma diagnosis for at least 1 year, currently prescribed an ICS, and having poor asthma control (ACT < 20) or a recent exacerbation. Excludes patients with life expectancy < 1 year, no ICS prescription, macrolide allergy, long QT interval, or recent systemic steroid use.

Endpoints

Primary

Rate of Asthma Exacerbations Per Year16 months

Secondary

Asthma Control Test16 months
Asthma Quality of Life Questionnaire16 months
Days Per Year Lost From Work or School16 months

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