NCT03238560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

August 1, 2017

Last Update Submit

August 2, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • 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

  • bronchoalveolar lavage fluid(BALF)

    To detect the concentrations of montelukast in bronchoalveolar lavage fluid

    Procedure (When the patient underwent fiberoptic bronchoscopy)

Interventions

Montelukast Chewable TabletDRUG

Montelukast treatment was used at a dosage of 5mg/day once daily

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The patients are cared in the department of pediatric respiratory at Shandong Provincial Qianfoshan Hospital, Jinan, China.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Ji'nan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wei Zhao, Ph.D

    Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308zhao4wei2@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of clinical pharmacy and pharmacology

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

CN(1)