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A Multicenter, Prospective, Randomized, Active-Controlled Study of the Efficacy and Safety of Fexofenadine Hydrochloride Dry Suspension in Children With Chronic Allergic Rhinitis With Asthma

A Multicenter, Prospective, Randomized, Active-Controlled Study of the Efficacy and Safety of Fexofenadine Hydrochloride Dry Suspension in Children With Chronic Allergic Rhinitis With Asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106217
Enrollment
Unknown
Registered
2025-07-21
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Allergic rhinitis with asthma

Interventions

Experimental group:The experimental group was given fexofenadine hydrochloride dry suspension twice a day, and then oral administration after suspension for 2 weeks.
Control group:The control group was given cetirizine hydrochloride oral solution twice daily for 2 weeks.

Sponsors

The First People's Hospital of Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 6-12 years old, gender is not limited; 2. Meet the diagnostic criteria for allergic rhinitis; 3. Meet the diagnostic criteria for asthma, with the diagnostic criteria referring to the Guidelines for the Prevention and Treatment of Bronchial Asthma (2016 Edition). 4. The asthma control levels are all classified as well - controlled, and the classification criteria refer to the Guidelines for the Prevention and Treatment of Bronchial Asthma (2016 Edition).

Exclusion criteria

Exclusion criteria: 1. Those who do not meet any of the inclusion criteria; 2. Exclude patients with severe liver diseases (ALT or AST or TBIL exceeding 1.5 times the upper limit of normal), kidney diseases (BUN greater than 1.5 times the upper limit of normal), or heart diseases (patients with cardiac function grade 3-4); 3. Have used anti-allergic drugs in the past week; 4. Children who take drugs for other diseases that may affect the results of this study; 5. Children who are allergic to the ingredients contained in this study; 6. The child has participated in other clinical studies; 7. Parent/guardian is unable to complete the record card; 8. Severe patients with obvious metabolic, and immunological, hematologic, cardiovascular, neurological, or respiratory diseases Subjects who, in the opinion of the investigator, may interfere with participation in the study or assessments.

Design outcomes

Primary

MeasureTime frame
Total nasal symptom score;Asthma control level;Therapeutic effectiveness;Subject compliance;

Secondary

MeasureTime frame
Accompanying symptoms;Visual analogue score of symptoms;Time to improvement of rhinitis symptoms;Time to improvement of asthma symptoms;Lung function indicators;

Countries

China

Contacts

Public ContactJiang Chunming

The First People's Hospital of Hangzhou

cm_jiang@126.com+86 136 0661 0578

Outcome results

None listed

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