Clinical trial NCT01265342: Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Official title: Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchial Spasm
Respiratory Sounds
Respiratory Tract Infections
Keywords: Bronchial Spasm
Respiratory Tract Infections
Viral wheezing
Child, Preschool
Beclomethasone
Italy
Physicians, Primary Care
Pediatrics
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Agenzia Italiana del Farmaco
name: Associazione Culturale Pediatri
First posted: 2010-12-23
Enrollment: 576
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* Outpatient children 1-5 years old
* Presence of any viral upper respiratory tract infection symptoms
* At least one episode of viral wheezing (diagnosed by a physician) in the last 12 months.
* No, or minimal, asthma-like symptoms in between separate airway infections

Exclusion Criteria:

* Steroid hypersensitivity
* Inhaled and/or oral corticosteroid use in the preceding month
* Chronic respiratory disease (e.g. cystic fibrosis, broncho-pulmonary dysplasia)
* Presence of wheezing at the entry visit

Primary outcomes:
measure: % of children with wheezing (diagnosed by the paediatrician) during the URTI episode.
Secondary outcomes:
measure: % of patients needing medical care during the treatment period;
measure: % of patients receiving rescue medication during the treatment period;
measure: % of patients admitted to an emergency department during the treatment period
measure: Duration of the respiratory tract infection episode
measure: % of patients with an asthma-like symptom score (rated by parents) >= 7
measure: Mean asthma-like symptom score for each child
measure: Time to the first viral wheezing episode after the end of the treatment
measure: Frequency of respiratory tract infection episodes during the 6 month follow-up period
measure: Frequency of viral wheezing episodes during the 6 month follow-up period
measure: % of parents who consider the treatment helpful
measure: % of patients fully adherent to therapy
measure: average cost per patient
Other outcomes:
Locations:
city: Castellammare di Stabia
country: Italy
facility: ASL NA/3 Sud
city: Chieti
country: Italy
facility: AUSL Chieti
city: Monza
country: Italy
facility: ASL Monza Brianza
city: Pinerolo
country: Italy
facility: ASL Torino 3
city: Reggio Calabria
country: Italy
facility: ASP di Reggio Calabria
city: Roma
country: Italy
facility: Ausl Roma E
city: Taranto
country: Italy
facility: AUSL Taranto
city: Verona
country: Italy
facility: Azienda ULSS 20 Verona
city: Viareggio
country: Italy
facility: ASL 12
Study officials:
affiliation: Mario Negri Institute for Pharmacological Research, Milan, Italy
name: Antonio Clavenna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M; ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics. 2014 Mar;133(3):e505-12. doi: 10.1542/peds.2013-2404. Epub 2014 Feb 17.