Asthma
Conditions
Interventions
A:Montelukast oral solution film
B:Montelukast chewable tablets or granules
Sponsors
Shanghai Children's Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 3-6 years old (including 3 years old, excluding 6 years old), regardless of gender 2. Children with mild asthma who require long-term control treatment, diagnosis criteria refer to the "Suggestions on the Standardized Diagnosis and Treatment of Children's Bronchial Ast (2020 Edition)" and the "Guidelines for the Diagnosis and Prevention of Children's Bronchial Asthma (2016 Edition) 3. Those who need to receive montelukast sodium treatment 4. Those who have signed a written informed consent form by the legal guardian, and the informed consent processies with the regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with severe hepatic dysfunction 2. Patients with a history of adverse reactions to leukotriene receptor antagonists 3 Patients with moderate or severe persistent asthma 4. Patients with a history of psychiatric disorders such as autism, ADHD 5. Patients who have used oral glucocortic within 1 week before screening or plan to use them during the study period 6. Patients who have participated in other clinical studies in the past 3 months 7. Other in which the subject is not suitable for inclusion as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRACK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma control evaluation;Compliance;Comparison of the degree of preference of the two groups of children, the acceptance of doctors or parents;Security; | — |
Countries
China
Contacts
Public ContactLibo Wang
Shanghai Children's Hospital, Fudan University
Outcome results
None listed