Azithromycin treatment for hospitalized children with asthma symptoms
Official title: Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
Run by Copenhagen Studies on Asthma in Childhood · NCT05028153 · Data updated 2026-11-12
This study is testing if a three-day treatment with azithromycin can help young children in the hospital with asthma symptoms feel better faster compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Months to 71 Months |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 1 site (Gentofte Municipality) |
| Status | Recruiting |
| Started | November 14, 2022 |
| Main results expected | November 13, 2026 |
| Study ends | November 13, 2032 |
| Registry record updated | April 13, 2025 |
| Trial ID | NCT05028153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1-5 years with a history of asthma-like symptoms and currently receiving SABA treatment.
✕Probably not a fit
Patients with known allergies to macrolide antibiotics or significant comorbidities such as liver or renal impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of a three-day azithromycin treatment compared to a placebo in children aged 1-5 years who are hospitalized due to asthma-like symptoms. The study includes children with a history of previous asthmatic episodes and aims to replicate earlier findings that suggested azithromycin can shorten the duration of these episodes. By focusing on individual responses to treatment, the study hopes to contribute to personalized asthma management based on the child's respiratory microbiome and immunological profile. The ultimate goal is to enhance understanding of bacterial influences on asthma in preschool children and improve treatment strategies.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the duration and severity of asthma episodes in young children.
How similar studies have gone: Previous studies have shown promising results with azithromycin in treating asthma-like symptoms, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA. * The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial. * The child is between 12-71 months old. * Fluent Danish skills with parents / guardians. Exclusion Criteria: * Known allergy to macrolide antibiotics. * Known impaired liver function. * Known renal impairment. * Known with neurological or psychiatric diseases. * Known with congenital or documented acquired QT interval. * Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure. * Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\> 50 and / or Fever: temperature\> 39 °C and / or C-reactive protein (CRP)\> 50).
Where it's running
-
University Hospital of Copenhagen
Gentofte Municipality, Denmark Recruiting
Study contacts
- Principal investigator: Jakob Stokholm, MD, PhD — University Hospital of Copenhagen, DK-2820 Gentofte, Denmark
- Study coordinator: Klaus Bønnelykke, MD, PhD
- Email: kb@copsac.com
- Phone: +4538677360
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.