Clinical trial NCT01233297: Antibiotic Treatment of Recurrent Episodes of Asthma in Children
Official title: Antibiotic Treatment of Recurrent Episode of Asthma in Children - a Randomised, Case-controlled Study Within the COPSAC2010 Cohort (Asthma Begins in Childhood)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Childhood Asthma With Acute Exacerbation
Keywords: wheeze
infections
Lead sponsor: Copenhagen Studies on Asthma in Childhood
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Symptom scoring
timeFrame: 1 to 3 years of age
measure: Duration in days of each asthmatic episode from randomisation start
timeFrame: 1 to 3 years of age
Secondary outcomes:
measure: need for PO steroids during the episode
timeFrame: 1 to 3 years of age
measure: beta-agonist use during the asthmatic episode
timeFrame: 1 to 3 years of age
measure: time lapse until the next asthmatic episode
timeFrame: 1 to 3 years of age
measure: MD assessment of the episode
timeFrame: 1 to 3 years of age
measure: Family's assessment of the episode
timeFrame: 1 to 3 years of age
measure: Asthma related health and economic assessment
timeFrame: 1 to 3 years of age
measure: percentage of time away from kindergarten or, for the parents, away from work
timeFrame: 1 to 3 years of age
measure: stratification of the above parameters according to bacterial colonisation of the airways
timeFrame: 1 to 3 years of age
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Copsac, DBAC
state: Copenhagen
city: Naestved
country: Denmark
facility: Copsac, Næstved Hospital, Pediatric Department
Study officials:
affiliation: Copenhagen Studies on Asthma in Childhood
name: Klaus Bønnelykke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.