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NCT00471809 · ClinicalTrials.gov registry record · Phase 4
Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
A Phase 4 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 4
- Development phase
- 210
- Enrollment target
NCT00471809 is a Phase 4 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 210 participants.
The verdict
NCT00471809, a Phase 4 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 210 participants
- Enrollment target
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.
Interventions
- DRUG Budesonide + Salmeterol + Azithromycin
- DRUG Budesonide + Salmeterol + Montelukast
- DRUG Budesonide + Salmeterol + Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00471809
The ClinicalTrials.gov registry entry for NCT00471809 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Budesonide + Salmeterol + Azithromycin is the first listed.
NCT00471809 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00471809 about?
NCT00471809 is a clinical study titled "Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)". 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 prima...
What is the current status of trial NCT00471809?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 210 participants. The study started on 2006-03. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00471809?
The interventions under investigation include: Budesonide + Salmeterol + Azithromycin (DRUG), Budesonide + Salmeterol + Montelukast (DRUG), Budesonide + Salmeterol + Placebo (DRUG).
Who is sponsoring clinical trial NCT00471809?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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