Efficacy of nebulised beclometasone versus placebo in preventing viral wheezing in pre-school children - Efficacy of Nebulised BEclometasone (ENBe)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011116-38-IT

Enrollment

576

Registered

2009-08-17

Start date

2009-10-04

Completion date

Unknown

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral wheezing MedDRA version: 9.1 Level: LLT Classification code 10006482

Interventions

Trade Name: CLENIL*AER 20FL 1D 0,8MG/2ML Pharmaceutical Form: Nebuliser suspension INN or Proposed INN: Beclometasone Concentration unit: µg microgram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatient children 1-5 years old. - - Presence of any 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of beclometasone in preventing wheezing in respiratory tract infection.;Primary end point(s): Percentage of children with wheezing (diagnosed by the paediatrician) during the respiratory tract infection episode.;Secondary Objective: To evaluate: - the efficacy of beclometasone in reducing symptom severity - the efficacy of beclometasone in reducing bronchodilator and/or corticosteroid use - the efficacy of beclometasone in reducing viral wheezing recurrence - treatment compliance - parental opinion on the treatment - the cost-efficacy ratio of prophylactic treatment with beclometasone.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of beclometasone in preventing wheezing in respiratory tract infection.;Primary end point(s): Percentage of children with wheezing (diagnosed by the paediatrician) during the respiratory tract infection episode.;Secondary Objective: To evaluate: - the efficacy of beclometasone in reducing symptom severity - the efficacy of beclometasone in reducing bronchodilator and/or corticosteroid use - the efficacy of beclometasone in reducing viral wheezing recurrence - treatment compliance - parental opinion on the treatment - the cost-efficacy ratio of prophylactic treatment with beclometasone.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026