ADDITION OF ANTIBIOTICS TO USUAL CARE MANAGEMENT OF ASTHMA EXACERBATIONS: A REALLIFE COMPARATIVE EFFECTIVENESS STUDY

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39106
• EU PAS number:
  EUPAS12132
• Study ID:
  39106
• Official title and acronym:
  ADDITION OF ANTIBIOTICS TO USUAL CARE MANAGEMENT OF ASTHMA EXACERBATIONS: A REALLIFE COMPARATIVE EFFECTIVENESS STUDY
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Asthma exacerbations are major contributors to asthma morbidity and mortality (and related costs). Their management presents a major clinical need that is not adequately met by current approaches. Respiratory viruses (especially rhinovirus) are the most common causes of asthma exacerbations and may be involved in the pathogenesis of chronic asthma in children, but there are other factors can increase the risk/severity of exacerbations. Recently evidence suggests atypical bacterial infections (such as Mycoplasma pneumonia and Chlamydophila) may also contribute to exacerbation severity. A recent randomised controlled (RCT) trial of telithromycin in adult patients (n=278) with acute exacerbations of asthma found a significant reduction in asthma symptoms among patients receiving add-on telithromycin compared with placebo. The mechanism or mechanisms of action was/were not determined. A second recent open-label randomised study, evaluating the effect of clarithromycin in children (n=40) with acute asthma suggests its use as add-on therapy may offer benefit over standard exacerbation treatment alone. Children in the trial were randomized to receive 15mg/kg of clarithromycin for 21 days in addition to their regular (GINA-guided) exacerbation treatment. Children were followed up with diary cards for 12 weeks, lung function was assessed at entry and at 3 and 12 weeks post exacerbation. Compared with controls, children receiving clarithromycin had an increase in their number of symptom-free days, a reduction in the number and severity of days with loss of control following index episode, and a decrease in the duration of the initial asthma exacerbation. Lung function did not differ between groups. These RCT findings warrant further exploration in larger more representative adult and paediatric routine care populations.
• Study status:
  Finalised

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 29/01/2016

Actual: 01/01/2017

Study start date

Planned: 15/02/2016

Actual: 01/07/2017

Date of final study report

Planned: 12/10/2016

Actual: 01/12/2020

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group

Study protocol

Initial protocol

REG Study Protocol_Effect of Abx on Paeditric Asthma Exacerbation Outcomes

Updated protocol

REG Study Protocol_Effect of Abx on Paeditric Asthma Exacerbation Outcomes_final version

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable