Asthma with allergic rhinitis
Conditions
Interventions
Montelukast sodium oral soluble membrane group:Montelukast sodium oral soluble film, once daily, one tablet (4mg) for three months.
Montelukast sodium chewable tablets group:Montelukast Sodium Chewable Tablets taken orally, 1 tablet (4mg) once daily for 3 months.
Sponsors
Children Hospital of Jiangxi Province
Eligibility
Sex/Gender
All
Age
3 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Age 3-5 years old (inclusive), gender is not limited; 2. Patients diagnosed or previously diagnosed with asthma by a physician; and complicated with allergic rhinitis; 3. Asthmatic children diagnosed with bronchial asthma according to Guidelines for Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition) and who have not been treated with high dose inhaled corticosteroids (ICS) in the past 1 month; 4. Subjects who meet the long-term treatment regimen of Chinese guidelines and need to choose the treatment regimen of Montelukast sodium Grade 2. 5. Patients admitted to the hospital from May 20, 2025 to June 1, 2027. 6. The informed consent process complies with regulations and the written informed consent form signed by the legal guardian.
Exclusion criteria
Exclusion criteria: 1. Patients with severe liver dysfunction; 2. Patients who have used monoclonal antibody therapy or specific immunotherapy in recent 3 months; 3. Asthma initial control therapy using high-dose ICS; 4. Adenoid hypertrophy and sinusitis; 5. Patients with psychiatric or other systemic chronic diseases previously diagnosed as tic disorder or tic disorder; 6. Those who have had adverse reactions to leukotriene receptor antagonists in the past; 7. Those who have used high-dose ICS or systemic glucocorticoids in the past 1 month. The child has not used systemic corticosteroids (oral prednisone or prednisolone, prednisolone for injection, or hydrocortisone succinate) in the past 12 months for respiratory problems that are not controlled by other medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child Respiratory and Asthma Control Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject Medication Compliance;Visual analogue score for rhinitis symptoms;Eosinophil count (percentage);Subject safety; | — |
Countries
China
Contacts
Public ContactLan Li
Children's Hospital of Jiangxi Province
Outcome results
None listed