Childhood Asthma MedDRA version: 21.1 Level: PT Classification code 10081274 Term: Childhood asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1 Level: LLT Classification code 10049868 Term: Asthma exacerbation prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Azithromycin
Pharmaceutical Form: Oral powder in single-dose container
INN or Proposed INN: Azithromycin
CAS Number: 121470-24-4
Current Sponsor code: J 01 FA 10
Other descriptive name: AZ
Sponsors
Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Previous episode (s) with asthma-like symptoms and/have medical treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. ? The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial. ? The child is between 12-71 months old. ? Fluent Danish skills with parents / guardians. Are the trial subjects under 18? yes Number of subjects for this age range: 320 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Known allergy to macrolide antibiotics. ? Known impaired liver function. ? Known renal impairment. ? Known with neurological or psychiatric diseases. ? Known with congenital or documented acquired QT interval. ? Known with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure. ? Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)> 50 and / or Fever: temperature> 39 ° C and / or C-reactive protein (CRP)> 50). ? Use of other medications, with possible Azithromycin interactions: ? Azithromycin may increase the effect of cecal alkaloids with risk of ergotism. The combination is contraindicated. ? The absorption of azithromycin is inhibited by simultaneous administration of antacids. ? Azithromycin is antagonistic in vitro to the bactericidal effect of penicillins and cephalosporins. ? Azithromycin can increase the concentration of: ¦ ciclosporin ¦ colchicine ¦ digoxin ¦ pimozide ¦ tacrolimus ? Caution when administering drugs that prolong the QT interval, e.g. amiodarone and other class IA and III antiarrhythmics and when treating with warfarin. ? Azithromycin may increase the incidence of side effects during treatment with rifabutin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, we will instead include hospitalized children who provide a more diverse group than the COPSAC2010 cohort.;Secondary Objective: The secondary purpose of the study is to focus on examining the individual response to treatment. The expectation is thus that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. It is also expected that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.;Primary end point(s): Duration (in days) of the asthma-like episode from the start of randomization.;Timepoint(s) of evaluation of this end point: Daily follow-up 30 days after initial dose of azithromycin. It is permitted to reply retrospectively for up to 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change in symptom score from day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years assessed using a previously validated symptom scoring model based on a diary. ? Effect modification in relation to the child's respiratory microbiota and immunological profile. ? The length of hospitalization. ? Need for SABA during the asthma-like episode. ? Need for oral corticosteroids (OCS) during the asthma-like episode. ? Stratification of the above analyzes on the basis of the presence or absence of bacteria in the airways. ? Percentage of days away from daycare offers and / or work for parents / guardians. ? Assessment of the health economic gain based on treatment costs and lost earnings for parent / guardian (s).;Timepoint(s) of evaluation of this end point: Daily follow-up 30 days after initial dose of azithromycin. Follow-up again after one year | — |
Countries
Denmark
Contacts
Public ContactCOSPAC
Herlev and Gentofte Hospital, Copenhagen Prospective Studies on Asthma in Childhood (COPSAC)
Outcome results
None listed