Clinical Trial: Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children
Brief 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 Summary:
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
Sponsor: Mario Negri Institute for Pharmacological Research
Current Primary Outcome: % of children with wheezing (diagnosed by the paediatrician) during the URTI episode.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- % of patients needing medical care during the treatment period;
- % of patients receiving rescue medication during the treatment period;
- % of patients admitted to an emergency department during the treatment period
- Duration of the respiratory tract infection episode
- % of patients with an asthma-like symptom score (rated by parents) >= 7
- Mean asthma-like symptom score for each child
- Time to the first viral wheezing episode after the end of the treatment
- Frequency of respiratory tract infection episodes during the 6 month follow-up period
- Frequency of viral wheezing episodes during the 6 month follow-up period
- % of parents who consider the treatment helpful
- % of patients fully adherent to therapy
- average cost per patient
Original Secondary Outcome: Same as current
Information By: Mario Negri Institute for Pharmacological Research
Dates:
Date Received: December 22, 2010
Date Started: October 2010
Date Completion:
Last Updated: March 10, 2014
Last Verified: March 2014
