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NCT03238560 Clinical Trial

The Population Pharmacokinetics of Montelukast in Infants and Children

Asthma Clinical Trial

Official title:
Population Pharmacokinetics of Montelukast in Infants and Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03238560
Other study ID # 2016Montelukast001
Secondary ID
Status Recruiting
Phase N/A
First received August 1, 2017
Last updated August 2, 2017
Start date October 1, 2016
Est. completion date June 1, 2018

Study information
Verified date August 2017
Source Shandong University
Contact Wei Zhao, Ph.D
Phone 86053188383308
Email zhao4wei2@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast Chewable Tablet
Montelukast treatment was used at a dosage of 5mg/day once daily

Locations
Country Name City State
China Shandong Provincial Qianfoshan Hospital Ji'nan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary plasma concentration To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration. 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration
Primary bronchoalveolar lavage fluid(BALF) To detect the concentrations of montelukast in bronchoalveolar lavage fluid Procedure (When the patient underwent fiberoptic bronchoscopy)
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