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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 is a Phase 1 study that has completed, run by Cuneyt M. Alper. The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01925729
The ClinicalTrials.gov registry entry for NCT01925729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cuneyt M. Alper, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxymetazoline is the first listed.
NCT01925729 reports 0 study locations.
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.
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