A Phase 1 interventional study of ragweed and histamine in Middle Ear Disease and Nasal Allergy, sponsored by Cuneyt M. Alper. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by Cuneyt M. Alper · Phase 1, Interventional, and Basic science
Among 300 studies in Hypersensitivity with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Hypersensitivity · United States.
Among the 300 studies in Hypersensitivity with a site in United States, this one is the 88th largest by enrollment of the 220 interventional ones that give a count, is one of 15 that started in 2013, is one of 31 in phase 1, and was the 158th registered.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
Browse Hypersensitivity studies →32 of the 300 studies in Hypersensitivity with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 12+
Lumicell, Inc. · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12–50
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 12 mo–17 yrs
Qifeng Zhang · Sites in United States, China
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 100 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 51 (51%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
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300 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 63 · Phase 3 41 · Phase 4 18
First in 1996; this study’s year is marked. 15 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 84 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Median enrollment 60 across the 220 interventional studies, 200 across the 76 observational. Of the 243 that completed or were terminated, 104 (43%) have results posted.
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117 of 300 have an industry lead sponsor. The 10 most frequent:
Cuneyt M. Alper is the lead sponsor of 5 studies on the registry; none are open to participants now.
Cuneyt M. Alper has 1 study filed under Hypersensitivity — fewer than ten, so there is no comparison to draw.
11 of the studies in Hypersensitivity with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07003919Phase 3DBV TechnologiesSafety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) | 2026-11 |
| NCT05584488Columbia UniversityAllergy and Immunology Natural History Study | 2027-01 |
| NCT07447869National Institute of Allergy and Infectious Diseases (NIAID)LYmph Node eXamination in Cat Allergen Immunotherapy | 2027-01-27 |
| NCT03914664Vanderbilt University Medical CenterNeural Correlates of Sensory Phenomena in Tourette Syndrome | 2027-02-28 |
| NCT06834165ARS Pharmaceuticals, Inc.Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy | 2027-04 |
Add all 11 to your calendar (.ics) → With an account.
Among the 300 studies in Hypersensitivity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The set of four experiments described here is a subcomponent of one Project included in a Clinical Research Center Grant Program focused on the physiology and pathophysiology of middle-ear (ME) pressure-regulation in children and adults. These experiments are designed to measure the rate of transME mucosal (transMEM) inert gas exchange in adults and determine if nasal inflammatory reactions experimentally provoked by intranasal histamine or allergen challenge increase the rate transMEM inert gas exchange and if nasal or oral treatment with an adrenergic agonist decreases that rate. Four cohorts of 20 otherwise healthy adults will be identified and one cohort assigned to each of the four experiments. All subjects will have a x-ray in Schuller projection to estimate mastoid volume. The transMEM inert gas exchange rate is measured by repeatedly recording ME pressure by tympanometry while the subject breathes a mixture of 50%N2O/ 50%O2, and then regressing ME pressure on time and dividing the slope of the function by the estimated N2O driving gradient to yield an exchange constant. For each experiment, the transMEM N2O exchange rate is measured twice at separate visits (active and placebo). The four experimental conditions are: (1) intranasal ragweed and placebo challenges; (2) intranasal histamine and placebo challenges; (3) oral pseudoephedrine and placebo; (4) intranasal oxymetazoline and placebo. Experiments 2-4 require two visits, while Experiment 1 will require an additional visit to obtain blood for RAST testing to verify ragweed allergy. The paired exchange constants measured in each experiment will be compared for a significant difference using a Student's Paired t test and the results interpreted as supporting or refuting the possibility of modulating the transMEM N2O exchange rate by the different procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ragweed -- 1000PNU intranasal spray
Biological: ragweed
5 mg intranasal spray
Biological: histamine
pseudoephedrine -- 60 mg orally
Drug: pseudoephedrine
oxymetazoline 0.05% solution intranasal spray
Drug: Oxymetazoline
ragweed arm only
histamine arm only
pseudoephedrine arm only
Also known as: Sudafed
oxymetazoline arm only
Also known as: Afrin
change in trans-middle ear N2O exchange constant
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.
Time frame: Visit 1 and Visit 2 (Visits 2 and 3 for ragweed arm) up to approximately 3 weeks
Ran from Oct 2013 to primary completion in Mar 2019, 65 months.
Of 26 phase 1 interventional studies under Hypersensitivity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 65 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Histamine · Pseudoephedrine · Oxymetazoline
Cuneyt M. Alper