Optimal dosage of cetirizine for treating allergic diseases in Chinese children

Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children

This study is testing the best dose of cetirizine, an allergy medicine, to help children with conditions like eczema and asthma feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 6 Months to 16 Years
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06288334 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore the pharmacokinetics of cetirizine, an antihistamine, in pediatric patients diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis. The study will involve administering cetirizine and collecting pharmacokinetic samples to determine the optimal dosage for effective treatment. Eligible participants include children aged 8 years and older who have not taken other antiallergic medications within 72 hours prior to screening. The trial is conducted at Peking University Third Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 8 years and older with a clinical diagnosis of allergic diseases requiring oral cetirizine therapy.

Not a fit: Patients with abnormal liver or renal function, electrolyte imbalances, or a history of serious reactions to cetirizine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and tailored treatment options for children suffering from allergic diseases.

How similar studies have performed: While the specific pharmacokinetics of cetirizine in Chinese children may not have been extensively studied, similar approaches in other populations have shown promise in optimizing allergy treatments.

Eligibility criteria

Inclusion Criteria:

1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

Exclusion Criteria:

1. Abnormal liver function (ALT or AST \> 2 times the upper limit of normal).
2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \< 10 mL/min)
3. Electrolyte abnormalities (potassium or magnesium \< 0.8 times lower limit of normal, \> 1.2 times upper limit of normal)
4. Children who were allergic to cetirizine or had a history of serious adverse reactions.
5. Pediatric patients with unstable vital signs.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Wei Zhou — Peking University Third Hospital
• Study coordinator: Dongyang Liu

Conditions Allergic Disease; Children