Skip to content

A real world study evaluating the compliance, efficacy, and safety montelukast sodium Oral soluble Film in the clinical treatment of children with asthma

A real world study evaluating the compliance, efficacy, and safety montelukast sodium Oral soluble Film in the clinical treatment of children with asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082495
Enrollment
Unknown
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Asthma

Interventions

Study Group:Montelukast sodium mouth solvent film

Sponsors

Beijing Children's Hospital, Capital University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age 3-14 years (inclusive) , regardless of gender; 2. Asthma diagnosed by a doctor or previous diagnosis 3. Children with asthma who had not been treated with high-dose ICS for nearly 1 month; 4. The subjects were in accordance with the long-term treatment plan of our country, and had to choose 3-4 grades, and had to adopt the combination therapy of middle-low dose ICS and LTRA (montelukast sodium) . 5. 2024 from 1 April to 31 October. 6. The informed consent process conforms to the provisions, and the written informed consent signed by the legal guardian.

Exclusion criteria

Exclusion criteria: 1. Severe liver failure 2. Patients who had been treated with mcab or Hapten therapy for the last 3 months. 3. High-dose ICS was used for initial control of asthma; 4. Adenoid hypertrophy, sinusitis, moderate to severe allergic rhinitis; 5. Previous diagnoses of chronic psychiatric or other systemic conditions such as tic disorder or tic disorder. 6. Previous adverse reactions to Leukotriene antagonist; 7. High doses of ICS or glucocorticoid have been used in the last month.

Design outcomes

Primary

MeasureTime frame
TRACK/C-ACT/ACT;

Secondary

MeasureTime frame
Palatability;Compliance; Assessment of asthma control;Lung function;Eosinophil granulocyte count;Security;

Countries

China

Contacts

Public ContactLi Xiang/Xiaoling Wang

Beijing Children's Hospital, Capital University of Medical Sciences

drxiangli@163.com+86 133 7011 0078

Outcome results

None listed

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