Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis

NCT ID: NCT01265342

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Bronchial Spasm; Respiratory Sounds; Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo nebulised suspension twice a day for 10 days

Beclomethasone

Beclometasone suspension 400 mcg will be administered through a nebuliser twice a day, in the morning and in the evening, for 10 days

Group Type: EXPERIMENTAL

Beclomethasone

Intervention Type: DRUG

Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days

Interventions

Beclomethasone

Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days

Intervention Type: DRUG

Placebo

Placebo nebulised suspension twice a day for 10 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agenzia Italiana del Farmaco

OTHER_GOV

Sponsor Role: collaborator

Associazione Culturale Pediatri

UNKNOWN

Sponsor Role: collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Clavenna, MD

Role: PRINCIPAL_INVESTIGATOR

Mario Negri Institute for Pharmacological Research, Milan, Italy

Locations

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, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 24534400 (View on PubMed)

Other Identifiers

2009-011116-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FARM7RANLZ

Identifier Type: -

Identifier Source: org_study_id