Skip to content
Study details
Enrolling now

PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia

Duke University
NCT IDNCT07101640ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Ages

≤0.536985860011622

Locations

4 sites in AR, NC, NV

About this study

This Phase 1/Phase 2 study is testing montelukast 4 mg granule in people with bronchopulmonary dysplasia bpd. The primary outcome being measured is Apparent clearance (CL/F) of montelukast.

Based on ClinicalTrials.gov records.

PhasePhase 1/Phase 2
Drugmontelukast 4 mg granule
Routeoral
Primary goalApparent clearance (CL/F) of montelukast

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low6%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

leukotriene inhibitor (Leukotriene receptor antagonist; reduces inflammation in airways)

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Apparent clearance (CL/F) of montelukast

Secondary: Area Under Curve (AUC), Half-life, Maximum Concentration (Cmax), Serious Adverse Events, Total Neuropsychiatric Adverse Events (NPAE)