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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Active Comparator | Azithromycin (10 mg/kg once a day for 3 days) |
|
| Placebo | Placebo Comparator | Placebo mixture (once a day for 3 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 10 mg/kg peroral for 3 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scoring | 1 to 3 years of age | |
| Duration in days of each asthmatic episode from randomisation start | 1 to 3 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Bønnelykke, MD, PhD | Copenhagen Studies on Asthma in Childhood | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copsac, DBAC | Gentofte Municipality | Copenhagen | 2820 | Denmark | ||
| Copsac, Næstved Hospital, Pediatric Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35105560 | Derived | 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. | |
| 33730519 |
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| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebo mixture |
| Other |
Placebo mixture containing no active substance. |
|
| 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 |
| Asthma related health and economic assessment | 1 to 3 years of age |
| percentage of time away from kindergarten or, for the parents, away from work | 1 to 3 years of age |
| stratification of the above parameters according to bacterial colonisation of the airways | 1 to 3 years of age |
| Næstved |
| 4700 |
| Denmark |
| Derived |
| 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. |
| 26704020 | Derived | 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. |
| Organic Chemicals |