Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis (ENBe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265342
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : March 11, 2014
Agenzia Italiana del Farmaco
Associazione Culturale Pediatri
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.

Condition or disease Intervention/treatment Phase
Bronchial Spasm Respiratory Sounds Respiratory Tract Infections Drug: Beclomethasone Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo nebulised suspension twice a day for 10 days

Experimental: Beclomethasone
Beclometasone suspension 400 mcg will be administered through a nebuliser twice a day, in the morning and in the evening, for 10 days
Drug: Beclomethasone
Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days

Primary Outcome Measures :
  1. % of children with wheezing (diagnosed by the paediatrician) during the URTI episode.

Secondary Outcome Measures :
  1. % of patients needing medical care during the treatment period;
  2. % of patients receiving rescue medication during the treatment period;
  3. % of patients admitted to an emergency department during the treatment period
  4. Duration of the respiratory tract infection episode
  5. % of patients with an asthma-like symptom score (rated by parents) >= 7
  6. Mean asthma-like symptom score for each child
  7. Time to the first viral wheezing episode after the end of the treatment
  8. Frequency of respiratory tract infection episodes during the 6 month follow-up period
  9. Frequency of viral wheezing episodes during the 6 month follow-up period
  10. % of parents who consider the treatment helpful
  11. % of patients fully adherent to therapy
  12. average cost per patient

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Ages Eligible for Study:   12 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01265342

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
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Agenzia Italiana del Farmaco
Associazione Culturale Pediatri
Principal Investigator: Antonio Clavenna, MD Mario Negri Institute for Pharmacological Research, Milan, Italy

Publications of Results:
Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT01265342     History of Changes
Other Study ID Numbers: FARM7RANLZ
2009-011116-38 ( EudraCT Number )
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Keywords provided by Mario Negri Institute for Pharmacological Research:
Bronchial Spasm
Respiratory Tract Infections
Viral wheezing
Child, Preschool
Physicians, Primary Care

Additional relevant MeSH terms:
Respiratory Tract Infections
Respiratory Sounds
Bronchial Spasm
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents