Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis

Respiratory Tract Infections Clinical Trial

— ENBe  

Official title:

Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265342
• Other study ID #: FARM7RANLZ
• Secondary ID: 2009-011116-38
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2010
• Last updated: March 10, 2014
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2014
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 71 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bronchial Spasm
• Respiratory Sounds
• Respiratory Tract Infections

Intervention

Drug:
• Beclomethasone
Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days
• Placebo
Placebo nebulised suspension twice a day for 10 days

Locations

Country	Name	City	State
Italy	ASL NA/3 Sud	Castellammare di Stabia
Italy	AUSL Chieti	Chieti
Italy	ASL Monza Brianza	Monza
Italy	ASL Torino 3	Pinerolo
Italy	ASP di Reggio Calabria	Reggio Calabria
Italy	Ausl Roma E	Roma
Italy	AUSL Taranto	Taranto
Italy	Azienda ULSS 20 Verona	Verona
Italy	ASL 12	Viareggio

Sponsors (3)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Agenzia Italiana del Farmaco, Associazione Culturale Pediatri

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of children with wheezing (diagnosed by the paediatrician) during the URTI episode.			No
Secondary	% of patients needing medical care during the treatment period;			No
Secondary	% of patients receiving rescue medication during the treatment period;			No
Secondary	% of patients admitted to an emergency department during the treatment period			Yes
Secondary	Duration of the respiratory tract infection episode			No
Secondary	% of patients with an asthma-like symptom score (rated by parents) >= 7			No
Secondary	Mean asthma-like symptom score for each child			No
Secondary	Time to the first viral wheezing episode after the end of the treatment			No
Secondary	Frequency of respiratory tract infection episodes during the 6 month follow-up period			No
Secondary	Frequency of viral wheezing episodes during the 6 month follow-up period			No
Secondary	% of parents who consider the treatment helpful			No
Secondary	% of patients fully adherent to therapy			No
Secondary	average cost per patient			No