Antibiotic Treatment of Recurrent Episodes of Asthma in Children
NCT ID: NCT01233297
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2010-11-30
2033-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Antibiotics
Azithromycin (10 mg/kg once a day for 3 days)
Azithromycin
10 mg/kg peroral for 3 consecutive days
Placebo
Placebo mixture (once a day for 3 days)
Placebo mixture
Placebo mixture containing no active substance.
Interventions
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Azithromycin
10 mg/kg peroral for 3 consecutive days
Placebo mixture
Placebo mixture containing no active substance.
Eligibility Criteria
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Inclusion Criteria
* recurrent wheeze
* and others
Exclusion Criteria
* Heart, liver or kidney disease.
* and others
1 Year
3 Years
ALL
No
Sponsors
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Copenhagen Studies on Asthma in Childhood
OTHER
Responsible Party
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Professor Klaus Bønnelykke
Professor
Principal Investigators
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Klaus Bønnelykke, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen Studies on Asthma in Childhood
Locations
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Copsac, DBAC
Gentofte Municipality, Copenhagen, Denmark
Copsac, Næstved Hospital, Pediatric Department
Næstved, , Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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2010-018592-16
Identifier Type: -
Identifier Source: org_study_id
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