Status:
COMPLETED
Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Associazione Culturale Pediatri
Conditions:
Bronchial Spasm
Respiratory Sounds
Eligibility:
All Genders
12-71 years
Phase:
PHASE4
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 e...
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% ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT01265342
Start Date
October 1 2010
End Date
October 1 2012
Last Update
March 11 2014
Active Locations (9)
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1
ASL NA/3 Sud
Castellammare di Stabia, Italy
2
AUSL Chieti
Chieti, Italy
3
ASL Monza Brianza
Monza, Italy
4
ASL Torino 3
Pinerolo, Italy