Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
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.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- 2007-03
Outcome
Missed primary endpoint
Stopped: “The CARE Network DSMB recommended to the NHLBI that the MARS trial be terminated, based on a futility analysis with 55 randomized children.”
paper no differences were noted for either treatment compared with placebo in time to inadequate control status PMID 18951618 ↗
paper with no difference between the groups (log-rank test, P = .49). PMID 18951618 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | — | Oral |
| Subject | Montelukast | Other / unclassified | — | Oral |
| Background | Budesonide | Small molecule | 800 ug | Inhaled |
| Background | Budesonide | Small molecule | 1600 ug | Inhaled |
| Background | Salmeterol | Other / unclassified | 50 ug | — |