Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: Agenzia Italiana del Farmaco; Associazione Culturale Pediatri
• Treatments: Beclomethasone

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