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NCT01925729 · ClinicalTrials.gov registry record · Phase 1
TransMEM Gas Exchange -- Project 1, Aim 2
A Phase 1 study, sponsored by Cuneyt M. Alper.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT01925729: Completed Phase 1 study, sponsored by Cuneyt M. Alper.
NCT01925729 is a Phase 1 study that has completed, run by Cuneyt M. Alper. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925729, a Phase 1 study, has completed, sponsored by Cuneyt M. Alper.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This study will determine if exposure to an allergy material (ragweed) or exposure to an allergic-symptom-provoking substance (histamine) and medications typically used to decongest the nose changes the rate of blood-flow in the lining of the middle-ear. Otitis media (the build-up of water-like fluid in the middle-ear airspace) may occur if the blood flow in the lining of the middle-ear is too high and may be prevented if a way could be found to lower the blood flow in persons susceptible to the disease. Middle-ear blood flow is measured indirectly by measuring the change in middle-ear pressure while a person breathes a gas mixture containing nitrous oxide ("laughing gas"). In this study, 4 groups of subjects will be entered and middle-ear pressure in persons breathing a mixture of 50% Oxygen, 50% Nitrous Oxide ("laughing gas")will be measured after exposure to one of four substances (ragweed, histamine,an oral decongestant, a decongestant nasal spray) and a fake medication (placebo) at separate test sessions. All subjects will have one set of 2 x-rays of the middle ears and mastoids. The group exposed to ragweed will require 3 study visits while the other 3 groups will have 2 study visits. From this information middle-ear blood flow will be calculated. This will help determine the relationship between what happens in the nose and what happens in the middle ear.
Primary Outcome
The transMEM N2O exchange constant is the primary outcome measure and is calculated as the slope of the line relating middle-ear pressure to time (until an observable active or passive ET opening) divided by the estimated extant N2O gradient.
Interventions
- DRUG Oxymetazoline
- BIOLOGICAL histamine
- BIOLOGICAL ragweed
- DRUG pseudoephedrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2019-03-22 |
| Phase | Phase 1 |
What the finished NCT01925729 record still lists
NCT01925729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 4 interventions - of which Oxymetazoline is the first listed.
NCT01925729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01925729 about?
NCT01925729 is a clinical study titled "TransMEM Gas Exchange -- Project 1, Aim 2". This study will determine if exposure to an allergy material (ragweed) or exposure to an allergic-symptom-provoking substance (histamine) and medications typically used to decongest the nose changes the rate of blood-flow in the lining of the middle-ear. Otitis media (the build-up of water-like flui...
What is the current status of trial NCT01925729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2013-10-01. Estimated completion is 2019-03-22.
What interventions are being tested in trial NCT01925729?
The interventions under investigation include: Oxymetazoline (DRUG), histamine (BIOLOGICAL), ragweed (BIOLOGICAL), pseudoephedrine (DRUG).
Who is sponsoring clinical trial NCT01925729?
This trial is sponsored by Cuneyt M. Alper, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925729's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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