Status: Ongoing First registered on: 19/01/2016
Last updated on: 18/03/2020
1. Study identification
EU PAS Register NumberEUPAS12132
Official titleADDITION OF ANTIBIOTICS TO USUAL CARE MANAGEMENT OF ASTHMA EXACERBATIONS: A REAL-LIFE COMPARATIVE EFFECTIVENESS STUDY
Study title acronym
Study typeObservational study
Brief description of the studyAsthma 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.
Was this study requested by a regulator?Don't know
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Professor
Last name Papadopoulos
First name Nikolaos
Is this study being carried out with the collaboration of a research network?
Yes

Respiratory Effectiveness Group (REG)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/01/201601/01/2017
Start date of data collection15/02/201601/07/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report12/10/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherRespiratory Effectiveness Group100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Papadopoulos
First name Nikolaos
Address line 1Centre of pediatrics and Child Health, Institute of Human Development
Address line 2University of Manchester 
Address line 3 
CityManchester 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address enquiries@regresearchnetwork.org
Public Enquiries
Title Professor 
Last name Papadopoulos 
First name Nikolaos 
Address line 1Centre of pediatrics and Child Health, Institute of Human Development 
Address line 2University of Manchester 
Address line 3 
CityManchester 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)4401223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address enquiries@regresearchnetwork.org 
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