Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms (COPSACazt)

Copenhagen Studies on Asthma in Childhood

Status and phase: Enrolling; Phase 2

Conditions: Childhood Asthma With Acute Exacerbation

Treatments: Drug: Azithromycin Oral Liquid Product; Other: Placebo mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT05028153

H-20065249

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 12 to 71 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups, including a placebo group

Antibiotics

Active Comparator group

Description:

Azithromycin (10mg/kg) administered via oral suspension for 3 consecutive days

Treatment:

Drug: Azithromycin Oral Liquid Product

Placebo

Placebo Comparator group

Description:

Placebo with no active substance administered via oral suspension for 3 consecutive days

Treatment:

Other: Placebo mixture