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Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00520754
Enrollment
15
Registered
2007-08-27
Start date
2001-12-31
Completion date
2003-03-31
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

Cough

Keywords

levocetirizine dihydrochloride Xyzal tablets

Brief summary

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Interventions

DRUGlevocetirizine dihydrochloride

Sponsors

UCB Pharma
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No

Inclusion criteria

* infants from 2 to 24 months both inclusive * suffering from recurrent cough associated with other allergic symptoms * hospitalized for respiratory or allergy related problems * laboratory results within normal ranges * height and weight between percentile 5 and 95

Exclusion criteria

* having taken any of the disallowed medication * suffering form any disorder * history of sleep apnea * having concomitant chronic disease * known relevant renal, hepatic, cardiac or metabolism dysfunction * known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Design outcomes

Primary

MeasureTime frame
The efficacy based on daily record cards recordings90 days

Secondary

MeasureTime frame
Safety and pharmacokinetics at 90 days; skin reactivity—

Outcome results

None listed

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