NCT05028153

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Copenhagen Studies on Asthma in Childhood · Academic / Other
• Sex: All
• Age: 12 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.

Detailed description

The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these. The study hypothesis is: ● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.

Conditions

• Childhood Asthma With Acute Exacerbation

Interventions

Type	Name	Description
DRUG	Azithromycin Oral Liquid Product	10 mg/kg for 3 consecutive days
OTHER	Placebo mixture	Placebo mixture containing no active substance

Timeline

• Start date: 2022-11-14
• Primary completion: 2026-11-13
• Completion: 2032-11-13
• First posted: 2021-08-31
• Last updated: 2025-04-13

Locations

1 site across 1 country: Denmark