REDS (REspiratory Drugs Survey) STUDY. Active surveillance of respiratory drugs, especially Inhaled Steroids (IS) in children (REDS STUDY)

Study identification

• EU PAS number:
  EUPAS12410
• Study ID:
  28894
• Official title and acronym:
  REDS (REspiratory Drugs Survey) STUDY. Active surveillance of respiratory drugs, especially Inhaled Steroids (IS) in children (REDS STUDY)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Despite the prevalence of Asthma has settled down to between 9.5 and 10.5% in children aged 6 to 11 years, it has been particularly noted that IS (beclomethasone, budesonide, flunisolide, fluticasone, etc.), are used inappropriately in children with an "over prescription" for conditions that do not require their use. Despite being an anti-asthmatic medicine, it is often prescribed for colds, coughs and sore throats. In the Enbe Study (Effectiveness of beclomethasone versus placebo in the treatment of preventing viral wheezing in the pre-school age group) beclomethasone reduced the risk of viral wheezing by 4% (from 11 to 7%) but the difference was not statistically significant. The results of Enbe confirms data already highlighted by some studies: that the IS has a modest effectiveness in preventing both recurrent wheezing viral and that of respiratory syncytial virus infections ( bronchiolitis) in the child. In addition, no benefits were noted in reducing symptoms of infection to the respiratory tract. Therefore a more rational effort is needed regarding these pharmaceuticals both by doctors and above all by parents who frequently administer medicines to children for infections of the respiratory tract, without consulting their pediatrician. Phase IV research project will be conducted by Family Pediatricians (FP) that can foresee on the one hand, training courses for FP and informational for families regarding the correct use of respiratory medication the ISs any iatrogenic illness caused by their improper use, on the other hand which may constitute a territorial survey on prescriptive appropriateness and safety of these pharmaceuticals in children aimed at evaluating the risk-benefit balance on usage.
• Study status:
  Finalised

Research institutions and networks

Institutions

FP-MCRN

Networks

Family Pediatricians - Medicines for Children Research Network (FP-MCRN)

Italy

Study timelines

Date when funding contract was signed

Planned:29/01/2016

Actual:29/01/2016

Study start date

Planned:11/10/2016

Actual:11/10/2016

Data analysis start date

Planned:11/10/2018

Actual:11/10/2018

Date of interim report, if expected

Planned:11/03/2018

Actual:11/03/2018

Date of final study report

Planned:11/02/2019

Actual:11/03/2019

Sources of funding

Other

More details on funding

AIFA (ITALIAN MEDICINES AGENCY)

Regulatory

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