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Evaluation of a treatment with levocetirizine in children allergic to mites suffering for recurrent respiratory infections with or without concomitant asthma symptoms - ND

Evaluation of a treatment with levocetirizine in children allergic to mites suffering for recurrent respiratory infections with or without concomitant asthma symptoms - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006379-19-IT
Enrollment
Unknown
Registered
2007-04-12
Start date
2007-05-08
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

persistent allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039085 Term: Rhinitis allergic

Interventions

Trade Name: XYZAL Pharmaceutical Form: Oral drops, solution Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Oral drops, solu

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: males and females 2-6 years old children with persistent rhinitis allergic to mites 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: . Acute respiratory infections in the last 30 month before the enrolment . Persistent asthma

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the efficacy of a trimestrial treatment with levocetirizine versus placebo on allergic nasal symtomps;Secondary Objective: To compare the efficacy of a monthly treatment with levocetirizine versus placebo on allergic nasal symtomps;Primary end point(s): To compare the efficacy of a trimestrial treatment with levocetirizine versus placebo on allergic nasal symtomps—

Countries

Italy

Outcome results

None listed

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