Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

NCT03277170 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged 5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung function, clinical severity, hospitalization rate and 72-hour symptom burden. Secondary Hypotheses:

1. 1.There are greater effects of high-dose oral montelukast on lung function and on the secondary outcomes in the presence of respiratory viral detection or leukotriene-mediated inflammation; and
2. 2.There is an interaction between viral detection and urinary leukotriene 4 level with treatment-response.

Conditions

Asthma; Status; Asthma in Children; Asthma Acute; Asthma Attack; Acute Asthma Exacerbation

Keywords

acute asthma exacerbation; pediatric asthma; leukotriene receptor antagonist; montelukast

Outcome Measures

Primary Outcomes (1)

• Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry

  Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration

  Before and 2-hours after treatment with montelukast or placebo

Secondary Outcomes (5)

• Change of percent-predicted forced expiratory volume in 1-second (FEV1)

  Before and 2-hours after treatment with montelukast or placebo

• Change of the Acute Asthma Intensity Research Score (AAIRS)

  Before and 2-hours after treatment with montelukast or placebo

• Leukotriene E4 (LTE4)

  Before treatment with montelukast or placebo

• 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)

  Before and at 72-hours after treatment with montelukast or placebo

• Hospitalization rate

  8-hours after treatment with montelukast or placebo

Study Arms (2)

High-dose Montelukast Oral Granules

EXPERIMENTAL

30 mg (high-dose) oral montelukast granules mixed in apple sauce will be administered orally immediately after informed consent and assent are obtained.

Drug: Montelukast Oral Granules

Placebo

PLACEBO COMPARATOR

Identical placebo mixed in apple sauce will be administered orally immediately after informed consent and assent are obtained.

Drug: Montelukast Oral Granules

Interventions

Montelukast Oral Granules DRUG

Montelukast granules, 30 mg, mixed with applesauce

Also known as: Singulair

High-dose Montelukast Oral Granules; Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 5 to 17 years, inclusive
• Parental report of asthma diagnosis by a health care provider
• At least one previous wheezing episode treated with albuterol
• Moderate or severe acute asthma exacerbation measured using the validated AAIRS bedside asthma severity score

You may not qualify if:

• Prior study enrollment
• Chronic lung disease other than asthma
• History of prematurity less than 34 weeks gestational age
• Acute or chronic liver disease
• Presence of tracheostomy
• Use of noninvasive ventilation at home
• Need for immediate airway intervention (e.g., endotracheal intubation or noninvasive ventilation)
• Allergy to montelukast
• Pregnancy
• Tuberculosis
• Gastroesophageal reflux requiring acid-blocking medication; and
• Prior use of an LTRA (e.g., montelukast)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Arnold DH, Bowman N, Reiss TF, Hartert TV, Seger DL. Adverse events are rare after single-dose montelukast exposures in children. Clin Toxicol (Phila). 2018 Jan;56(1):25-29. doi: 10.1080/15563650.2017.1337123. Epub 2017 Jun 22.

  PMID: 28639856 RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald H Arnold, MD, MPH

  Vanderbilt University School of Medicine, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug (montelukast granules) and identical control will be prepared by the Vanderbilt Investigational Drug service. Participants will be randomized by computerized program by study biostatistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Emergency Medicine

Model Details: Two-arm, parallel randomized controlled trial

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 5, 2029
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after study closure
• Access Criteria: Criteria will include qualified investigators with data sharing plan approved by Vanderbilt Office of Special Projects.

Locations

US (1)