Childhood Asthma With Acute ExacerbationPhase 2AB-studieNCT01233297
Antibiotic Treatment of Recurrent Episodes of Asthma in Children
A Phase 2 study testing Azithromycin in people with Childhood Asthma With Acute Exacerbation, run by Copenhagen Studies on Asthma in Childhood at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Childhood Asthma With Acute Exacerbation
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2010to Oct 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participation in the COPSAC2010 cohort
- recurrent wheeze
- and others
Who cannot join
- Macrolide allergy
- Heart, liver or kidney disease.
- and others
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copsac, DBAC
Gentofte Municipality, Copenhagen, 2820
Copsac, Næstved Hospital, Pediatric Department
Næstved, 4700
About this study
Official title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
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.
- Conditions
- Childhood Asthma With Acute Exacerbation
- Being tested
- Azithromycin, Placebo mixture
- Keywords
- wheeze, infections
- Medical subject headings
- Respiratory Sounds, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
10 mg/kg peroral for 3 consecutive days
Placebo mixtureOther
Placebo mixture containing no active substance.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Active comparator | Azithromycin (10 mg/kg once a day for 3 days) Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Placebo mixture (once a day for 3 days) Receives: Other: Placebo mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scoring
Measured: 1 to 3 years of age
Duration in days of each asthmatic episode from randomisation start
Measured: 1 to 3 years of age
Secondary outcomes (8)
need for PO steroids during the episode
Measured: 1 to 3 years of age
beta-agonist use during the asthmatic episode
Measured: 1 to 3 years of age
time lapse until the next asthmatic episode
Measured: 1 to 3 years of age
MD assessment of the episode
Measured: 1 to 3 years of age
Family's assessment of the episode
Measured: 1 to 3 years of age
Asthma related health and economic assessment
Measured: 1 to 3 years of age
percentage of time away from kindergarten or, for the parents, away from work
Measured: 1 to 3 years of age
stratification of the above parameters according to bacterial colonisation of the airways
Measured: 1 to 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2027 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood Asthma With Acute ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Studies on Asthma in Childhood
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Klaus Bønnelykke, Copenhagen Studies on Asthma in Childhood
- Investigators
- Klaus Bønnelykke, MD, PhD, Principal investigator, Copenhagen Studies on Asthma in Childhood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233297
- Sponsor's protocol ID
- 2010-018592-16
- Acronym
- AB-studie
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2010
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35105560Thorsen 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.
PubMed 33730519Stokholm 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.
PubMed 26704020