NCT01233297

Brief Summary

Copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. The current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. Macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
90mo left

Started Nov 2010

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not 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 Progress68%
Nov 2010Oct 2033

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
16.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2033

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

16.9 years

First QC Date

November 2, 2010

Last Update Submit

March 17, 2026

Conditions

Childhood Asthma With Acute Exacerbation

Keywords

wheezeinfections

Outcome Measures

Primary Outcomes (2)

  • Symptom scoring

    1 to 3 years of age

  • Duration in days of each asthmatic episode from randomisation start

    1 to 3 years of age

Secondary Outcomes (8)

  • need for PO steroids during the episode

    1 to 3 years of age

  • beta-agonist use during the asthmatic episode

    1 to 3 years of age

  • time lapse until the next asthmatic episode

    1 to 3 years of age

  • MD assessment of the episode

    1 to 3 years of age

  • Family's assessment of the episode

    1 to 3 years of age

  • +3 more secondary outcomes

Study Arms (2)

Antibiotics

ACTIVE COMPARATOR

Azithromycin (10 mg/kg once a day for 3 days)

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Placebo mixture (once a day for 3 days)

Other: Placebo mixture

Interventions

AzithromycinDRUG

10 mg/kg peroral for 3 consecutive days

Antibiotics
Placebo mixtureOTHER

Placebo mixture containing no active substance.

Placebo

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participation in the COPSAC2010 cohort
  • recurrent wheeze
  • and others

You may not qualify if:

  • Macrolide allergy
  • Heart, liver or kidney disease.
  • and others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copsac, DBAC

Gentofte Municipality, Copenhagen, 2820, Denmark

Location

Copsac, Næstved Hospital, Pediatric Department

Næstved, 4700, Denmark

Location

Related Publications (3)

  • Mohammadzadeh P, Rosenberg JB, Vinding R, Mollegaard Jepsen JR, Lindberg U, Folsgaard N, Erlang Sorensen M, Sulaiman D, Bilenberg N, Mitta Raghava J, Fagerlund B, Vestergaard M, Pantelis C, Stokholm J, Chawes B, Larsson H, Glenthoj BY, Bonnelykke K, Ebdrup BH, Bisgaard H. Effects of prenatal nutrient supplementation and early life exposures on neurodevelopment at age 10: a randomised controlled trial - the COPSYCH study protocol. BMJ Open. 2022 Feb 1;12(2):e047706. doi: 10.1136/bmjopen-2020-047706.

    PMID: 35105560DERIVED

  • Thorsen J, Stokholm J, Rasmussen MA, Mortensen MS, Brejnrod AD, Hjelmso M, Shah S, Chawes B, Bonnelykke K, Sorensen SJ, Bisgaard H. The Airway Microbiota Modulates Effect of Azithromycin Treatment for Episodes of Recurrent Asthma-like Symptoms in Preschool Children: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2021 Jul 15;204(2):149-158. doi: 10.1164/rccm.202008-3226OC.

    PMID: 33730519DERIVED

  • Stokholm J, Chawes BL, Vissing NH, Bjarnadottir E, Pedersen TM, Vinding RK, Schoos AM, Wolsk HM, Thorsteinsdottir S, Hallas HW, Arianto L, Schjorring S, Krogfelt KA, Fischer TK, Pipper CB, Bonnelykke K, Bisgaard H. Azithromycin for episodes with asthma-like symptoms in young children aged 1-3 years: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Jan;4(1):19-26. doi: 10.1016/S2213-2600(15)00500-7. Epub 2015 Dec 17.

    PMID: 26704020DERIVED

MeSH Terms

Conditions

Respiratory SoundsInfections

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Klaus Bønnelykke, MD, PhD

    Copenhagen Studies on Asthma in Childhood

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

November 1, 2010

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2033

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

DK(2)