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Antibiotic Treatment of Recurrent Episodes of Asthma in Children (AB-studie)

Primary Purpose

Childhood Asthma With Acute Exacerbation

Status
Active
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Azithromycin
Placebo mixture
Sponsored by
Copenhagen Studies on Asthma in Childhood
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Asthma With Acute Exacerbation focused on measuring wheeze, infections

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Copsac, DBAC
  • Copsac, Næstved Hospital, Pediatric Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antibiotics

Placebo

Arm Description

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

Placebo mixture (once a day for 3 days)

Outcomes

Primary Outcome Measures

Symptom scoring
Duration in days of each asthmatic episode from randomisation start

Secondary Outcome Measures

need for PO steroids during the episode
beta-agonist use during the asthmatic episode
time lapse until the next asthmatic episode
MD assessment of the episode
Family's assessment of the episode
Asthma related health and economic assessment
percentage of time away from kindergarten or, for the parents, away from work
stratification of the above parameters according to bacterial colonisation of the airways

Full Information

First Posted
November 2, 2010
Last Updated
November 21, 2022
Sponsor
Copenhagen Studies on Asthma in Childhood
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1. Study Identification

Unique Protocol Identification Number
NCT01233297
Brief Title
Antibiotic Treatment of Recurrent Episodes of Asthma in Children
Acronym
AB-studie
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen Studies on Asthma in Childhood

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma With Acute Exacerbation
Keywords
wheeze, infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics
Arm Type
Active Comparator
Arm Description
Azithromycin (10 mg/kg once a day for 3 days)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo mixture (once a day for 3 days)
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
10 mg/kg peroral for 3 consecutive days
Intervention Type
Other
Intervention Name(s)
Placebo mixture
Intervention Description
Placebo mixture containing no active substance.
Primary Outcome Measure Information:
Title
Symptom scoring
Time Frame
1 to 3 years of age
Title
Duration in days of each asthmatic episode from randomisation start
Time Frame
1 to 3 years of age
Secondary Outcome Measure Information:
Title
need for PO steroids during the episode
Time Frame
1 to 3 years of age
Title
beta-agonist use during the asthmatic episode
Time Frame
1 to 3 years of age
Title
time lapse until the next asthmatic episode
Time Frame
1 to 3 years of age
Title
MD assessment of the episode
Time Frame
1 to 3 years of age
Title
Family's assessment of the episode
Time Frame
1 to 3 years of age
Title
Asthma related health and economic assessment
Time Frame
1 to 3 years of age
Title
percentage of time away from kindergarten or, for the parents, away from work
Time Frame
1 to 3 years of age
Title
stratification of the above parameters according to bacterial colonisation of the airways
Time Frame
1 to 3 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in the COPSAC2010 cohort recurrent wheeze and others Exclusion Criteria: Macrolide allergy Heart, liver or kidney disease. and others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Bønnelykke, MD, PhD
Organizational Affiliation
Copenhagen Studies on Asthma in Childhood
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copsac, DBAC
City
Gentofte
State/Province
Copenhagen
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Copsac, Næstved Hospital, Pediatric Department
City
Naestved
ZIP/Postal Code
4700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35105560
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.
Results Reference
derived
PubMed Identifier
33730519
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.
Results Reference
derived
PubMed Identifier
26704020
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.
Results Reference
derived

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Antibiotic Treatment of Recurrent Episodes of Asthma in Children

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