Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Condition: Bronchial Spasm; Respiratory Sounds; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Bronchial Spasm; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      Inhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic
      treatment of upper respiratory infections without evidence of efficacy.

      The purpose of this study is to evaluate the efficacy of beclomethasone (administered by
      nebuliser twice a day) in preventing viral wheezing in pre-school children who had had
      episodes in the preceding 12 months.
    

Detailed description: 
      Viral wheezing (intermittent episodes of wheezing induced by viral infection of the upper
      respiratory tract) is a common condition in pre-school children. Its incidence is estimated
      between 6 and 30% and varies depending on criteria, diagnosis, and age definition used. Viral
      wheezing, however, is different from atopic asthma, since in 60% of cases symptoms disappear
      before the age of 6 . The efficacy of drug treatments in the prevention and/or treatment of
      viral wheezing is controversial; short acting beta 2 agonists are often considered first
      choice therapies even if evidence is scarce The usefulness of inhaled steroids is also
      debated: no benefits are documented for maintenance with low dose inhaled corticosteroids,
      while their episodic use at a high dose may have a modest improvement in symptoms. Despite
      the scant evidence, however, nebulised steroids in particular beclomethasone, are widely
      prescribed in Italy as prophylaxis or treatment for viral wheezing. Beclometasone is the
      third most prescribed drug in Italian children, with a prevalence estimated around 15% A
      randomized placebo-controlled trial was therefore planned to evaluate the effectiveness of
      nebulised beclometasone in preventing viral wheezing in children with upper respiratory tract
      infections. Besides investigating the drug efficacy, the study could also monitor the
      incidence of viral wheezing recurrence in preschool children, the disease's natural history
      and the different therapeutic approaches used by the physicians.

      The study will involve 36 Italian family paediatricians from 9 local health units. Children
      will be randomized to receive beclomethasone or placebo.

      The treatment period will last 10 days, and it will be followed by an observational 6 month
      follow-up period.

      Three visits are scheduled: the first at baseline, the second at the end of the treatment
      period and the third at the end of follow-up period.

      During the 10 day treatment period, symptoms will be recorded by the parents on a diary. A
      clinical evaluation will be performed by the paediatrician during the entry visit and at the
      end of the treatment period. Moreover, parents will be requested to contact the paediatrician
      if wheezing occurs during the treatment period and/or the child does not improve within 72
      hours from the start of the therapy.

      In case of wheezing and/or lack of improvement, paediatricians should visit the child,
      evaluate the presence of wheezing and rate it. A wheeze score will be assigned as follows: 0
      = no wheezing, 1 = end-expiratory wheeze only, 2 = wheeze during entire expiratory with or
      without inspiratory phase, audible with stethoscope only, 3 = inspiratory and expiratory
      wheezing audible without stethoscope.
    

Intervention name(s): Beclomethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days; Placebo nebulised suspension twice a day for 10 days
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bronchial Spasm; Respiratory Tract Infections; Viral wheezing; Child, Preschool; Beclomethasone; Italy; Physicians, Primary Care; Pediatrics