Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis (ENBe)

This study has been completed.
Sponsor:
Collaborators:
Agenzia Italiana del Farmaco
Associazione Culturale Pediatri
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01265342
First received: December 22, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Bronchial Spasm
Respiratory Sounds
Respiratory Tract Infections
Drug: Beclomethasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • % of children with wheezing (diagnosed by the paediatrician) during the URTI episode. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % of patients needing medical care during the treatment period; [ Designated as safety issue: No ]
  • % of patients receiving rescue medication during the treatment period; [ Designated as safety issue: No ]
  • % of patients admitted to an emergency department during the treatment period [ Designated as safety issue: Yes ]
  • Duration of the respiratory tract infection episode [ Designated as safety issue: No ]
  • % of patients with an asthma-like symptom score (rated by parents) >= 7 [ Designated as safety issue: No ]
  • Mean asthma-like symptom score for each child [ Designated as safety issue: No ]
  • Time to the first viral wheezing episode after the end of the treatment [ Designated as safety issue: No ]
  • Frequency of respiratory tract infection episodes during the 6 month follow-up period [ Designated as safety issue: No ]
  • Frequency of viral wheezing episodes during the 6 month follow-up period [ Designated as safety issue: No ]
  • % of parents who consider the treatment helpful [ Designated as safety issue: No ]
  • % of patients fully adherent to therapy [ Designated as safety issue: No ]
  • average cost per patient [ Designated as safety issue: No ]

Estimated Enrollment: 576
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Months to 71 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265342

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

Publications:
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01265342     History of Changes
Other Study ID Numbers: FARM7RANLZ, 2009-011116-38
Study First Received: December 22, 2010
Last Updated: March 10, 2014
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Bronchial Spasm
Respiratory Sounds
Respiratory Tract Infections
Spasm
Bronchial Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Infection
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 22, 2014