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NCT00156819 · ClinicalTrials.gov registry record · Phase 4
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
A Phase 4 study, sponsored by JHSPH Center for Clinical Trials.
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
NCT00156819: Completed Phase 4 study, sponsored by JHSPH Center for Clinical Trials.
NCT00156819 is a Phase 4 study that has completed, run by JHSPH Center for Clinical Trials. The registered enrollment target is 500 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00156819, a Phase 4 study, has completed, sponsored by JHSPH Center for Clinical Trials.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
Study Summary
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
Primary Outcome
The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value me
Interventions
- DRUG montelukast
- DRUG fluticasone
- DRUG Fluticasone plus salmeterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2003-06 |
| Est. Completion | 2006-08 |
| Phase | Phase 4 |
What the finished NCT00156819 record still lists
NCT00156819 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which montelukast is the first listed.
NCT00156819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00156819 about?
NCT00156819 is a clinical study titled "The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial". This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of ...
What is the current status of trial NCT00156819?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2003-06. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00156819?
The interventions under investigation include: montelukast (DRUG), fluticasone (DRUG), Fluticasone plus salmeterol (DRUG).
Who is sponsoring clinical trial NCT00156819?
This trial is sponsored by JHSPH Center for Clinical Trials, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00156819's enrollment target sits among peer trials
500 165th of 2000 higher than 1,824 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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