Treating Exacerbations of Asthma With Oral Montelukast in Children

Conditions

• Status Asthmaticus

Eligibility Criteria

Sex

ALL

Age

4 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Montelukast Oral Granules — DRUG
  Oral montelukast granules, USP powder, or crushed tablets at weight-based doses between 2 mg/kg and 3 mg/kg to a maximum of 180 mg.
• Albuterol — DRUG
  Inhaled albuterol by metered-dose inhaler (MDI) or nebulizer
• Corticosteroid — DRUG
  Oral or parenteral corticosteroid (e.g., dexamethasone, methylprednisolone)

Study Details

This research will establish a mg/kg dose for a future RCT to determine the efficacy of high-dose oral montelukast for children with moderate and severe acute asthma exacerbations. Aim: Perform an adaptive, double-masked randomized controlled trial (RCT) of high-dose oral montelukast, with escalating mg/kg dose levels determined by PK-guided dose modeling, added to standard treatment versus standard treatment alone, in children with exacerbations that are moderate or severe after initial treatment with inhaled albuterol. Hypothesis 1: High-dose oral montelukast achieves peak plasma concentration (Cmax) \>1,700 ng/ml in \>86% of at least one of three sequential participant groups with escalating weight-based (milligram/kilogram or mg/kg) doses between groups. Hypothesis 2: Participants randomized to high-dose oral montelukast have a 2 point or greater improvement of the validated Acute Asthma Intensity Research Score (AAIRS) at 4 hours post-treatment in comparison with control group participants. Hypothesis 3: Among montelukast recipients, Cmax correlates with change of the AAIRS at 4 hours, after adjustment for pre-treatment exacerbation severity and systemic leukotriene stress measured using urinary leukotriene E4 (LTE4).

Key Dates

Start date

Oct 20, 2023

Status verified

Jun 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: High-dose oral montelukast plus standard treatment
  Escalating dose-levels of oral montelukast between 2 mg/kg and 3 mg/kg determined by pharmacokinetic-guided dose modeling, added to standard, guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).
• Placebo Comparator: Identical placebo plus standard treatment
  Guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).

Primary Outcome Measure

Montelukast plasma level [ Time Frame: 4 hours ]

Central Contacts

• Donald H Arnold, MD, MPH
  16155790516
  [email protected]

Locations (1)

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