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Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)

NCT00471809 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-07-29

No results posted yet for this study

Summary

The MARS trial is a randomized, double-blind, parallel group study that compares the capacity of azithromycin or montelukast to placebo as effective adjunctive therapy that allows reduction of inhaled corticosteroids in children ages 6 to 17 years with moderate to severe persistent asthma. The primary null hypothesis is that in children with moderate-to-severe persistent asthma, a macrolide antibiotic (azithromycin) or a leukotriene receptor antagonist (montelukast) will provide a steroid-sparing effect when compared to placebo as the dose of inhaled corticosteroid is reduced. This will be tested following achievement of control of symptoms with moderate to high-dose inhaled corticosteroid in combination with a long-acting bronchodilator agonist. Use of these doses for the inhaled corticosteroid will be based on NHLBI step-up guidelines to achieve asthma control.

Conditions

Interventions

DRUG

Budesonide + Salmeterol + Azithromycin

DRUG

Budesonide + Salmeterol + Montelukast

DRUG

Budesonide + Salmeterol + Placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Vernon M. Chinchilli, PhD · Penn State College of Medicine

  • Stanley J. Szefler, MD, PhD · National Jewish Health

  • Robert F. Lemanske, Jr., MD · University of Wisconsin, Madison

  • Robert S. Zeiger, MD, PhD · Kaiser Permanente Medical Center

  • Robert C. Strunk, MD · Washington University School of Medicine

  • Fernando D. Martinez, MD · University of Arizona College of Medicine

  • Lynn M. Taussig, MD · University of Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00471809 on ClinicalTrials.gov