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NCT01016847 · ClinicalTrials.gov registry record · Phase 4
Moderate to Persistent Asthma in the Obese Subject
A Phase 4 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT01016847: Clinical Trial Phase 4 study, sponsored by Duke University.
NCT01016847 is a Phase 4 study that was terminated before completion, run by Duke University. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01016847, a Phase 4 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)\[LTRA\] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.
Interventions
- DRUG Montelukast
- OTHER Sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
Why NCT01016847 stopped before completion
NCT01016847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Montelukast is the first listed.
NCT01016847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01016847 about?
NCT01016847 is a clinical study titled "Moderate to Persistent Asthma in the Obese Subject". Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)\[LTRA\] to moderate doses of inhaled cortico...
What is the current status of trial NCT01016847?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2010-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01016847?
The interventions under investigation include: Montelukast (DRUG), Sugar pill (OTHER).
Who is sponsoring clinical trial NCT01016847?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01016847's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 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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