Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00542607

Enrollment

Registered

2007-10-11

Start date

2002-09-30

Completion date

2002-12-31

Last updated

2013-12-12

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

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Levocetirizine dihydrochloride, Xyzal tablets

Brief summary

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Interventions

DRUGlevocetirizine dihydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* adults 18 to 55 years both inclusive * suffering at least 2 years of seasonal allergic rhinitis due to grass pollen * positive RAST and/or positive skin prick test * comply with study restrictions

Exclusion criteria

* known alcohol or drug addiction or abuse * known allergy/intolerance to lactose, cellulose, cornstarch * presence of nasal anatomical deformities leading to \> 50% obstruction * ENT infection within 30 days of the study * use of disallowed medication * ongoing desensitization * known cardiac, renal or hepatic dysfunction * presenting allergic bronchial asthma * use of cimetidine * intending to donate blood during the trial

Design outcomes

Primary

Measure	Time frame
Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage	—

Secondary

Measure	Time frame
The change from baseline of the mean MSC score over time interval 3	—
the change from baseline of the mean MSC score over time intervals 1 and 4.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026