The Population Pharmacokinetics of Montelukast in Infants and Children

• Conditions: Asthma

• Registration Number: NCT03238560
• Lead Sponsor: Shandong University

Brief Summary

The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.

Exclusion Criteria

• expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bronchoalveolar lavage fluid(BALF)	Procedure (When the patient underwent fiberoptic bronchoscopy)	To detect the concentrations of montelukast in bronchoalveolar lavage fluid
plasma concentration	3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration	To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.

Trial Locations

Locations (1)

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Ji'nan, Shandong, China