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Efficacy and safety of levocetirizine hydrochloride in children with allergic diseases

Efficacy and safety of levocetirizine hydrochloride in children with allergic diseases

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056933
Enrollment
Unknown
Registered
2022-02-23
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

allergic diseases

Interventions

observation group:Take levocetirizine hydrochloride oral solution, once a night, 1.25mg (2.5ml) each time, for 2 consecutive weeks

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 2 Years

Inclusion criteria

Inclusion criteria: 1.Age 6 months to 2 years old, gender is not limited; 2.Have one or more general symptoms of allergic rhinitis (two or more local symptoms such as nasal congestion, watery rhinorrhea, nasal itching, sneezing, etc.), and the symptoms persist or accumulate for more than 1 hour per day; It may be accompanied by eye symptoms such as tearing, itching and congestion, and signs of allergic rhinitis: pale nasal mucosa, edema, and watery nasal discharge; 3.Able to obtain the written consent of the guardian; 4.The guardian can write a diary on behalf of the children.

Exclusion criteria

Exclusion criteria: 1. Children who are allergic to or have a history of allergy to the components of levocetirizine hydrochloride preparations or piperazine derivatives such as oxocetirizine cyclozine; 2. Children with a history of drug allergy; 3. Children who are taking some banned drugs (systemic corticosteroids, antileukotrienes, nedoromic acid and other antihistamines, systemic antibiotics, and other drugs judged to affect the test); 4. If the breast-feeding mother has children who take antihistamines during the trial; 5. Children who have used systemic corticosteroids within 30 days before the start of the treatment period; 6. Children who are undergoing immunotherapy or scheduled to start immunotherapy during the clinical study.

Design outcomes

Primary

MeasureTime frame
adverse event;Allergic Rhinitis Symptom Score;

Countries

China

Contacts

Public ContactZhang Jie

Beijing Children's Hospital, Capital Medical University

stzhangj@263.net+86 13370115055

Outcome results

None listed

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