NCT05028153

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
80mo left

Started Nov 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Nov 2022Nov 2032

First Submitted

Initial submission to the registry

August 19, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2026

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2032

Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

August 19, 2021

Last Update Submit

April 9, 2025

Conditions

Childhood Asthma With Acute Exacerbation

Keywords

AsthmaInfectionsWheezeAntibiotics

Outcome Measures

Primary Outcomes (1)

  • Duration in days of the asthma-like episode from the start of randomization.

    Number of days based on a diary.

    1-30 days

Secondary Outcomes (12)

  • Change in symptom score.

    From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.

  • Effect modification in relation to the child's respiratory microbiota profile.

    Sample time, day 1

  • Effect modification in relation to the child's respiratory immunological profile.

    Sample time, day 1

  • The length of hospitalization (days)

    1-30 days

  • Need for SABA during the asthma-like episode

    1-30 days

  • +7 more secondary outcomes

Study Arms (2)

Antibiotics

ACTIVE COMPARATOR

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

Drug: Azithromycin Oral Liquid Product

Placebo

PLACEBO COMPARATOR

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

Other: Placebo mixture

Interventions

Azithromycin Oral Liquid ProductDRUG

10 mg/kg for 3 consecutive days

Antibiotics
Placebo mixtureOTHER

Placebo mixture containing no active substance

Placebo

Eligibility Criteria

Age12 Months - 71 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen

Gentofte Municipality, 2820, Denmark

RECRUITING

Related Publications (1)

  • Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762.

    PMID: 35418427DERIVED

MeSH Terms

Conditions

AsthmaInfectionsRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob Stokholm, MD, PhD

    University Hospital of Copenhagen, DK-2820 Gentofte, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Bønnelykke, MD, PhD

CONTACT

+4538677360kb@copsac.com

Ulrik Ralfkiaer, MSc, PhD

CONTACT

+4538674164administration@dbac.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 31, 2021

Study Start

November 14, 2022

Primary Completion (Estimated)

November 13, 2026

Study Completion (Estimated)

November 13, 2032

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations

DK(1)