- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925729
TransMEM Gas Exchange -- Project 1, Aim 2
February 5, 2020 updated by: Cuneyt M. Alper
Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific 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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Middle Ear Physiology Laboratory, University of PIttsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
- no evidence of otitis media at entry
- bilaterally intact tympanic membranes
- ragweed arm: history of symptomatic ragweed allergy and Class 2 positive on RAST testing with or without other allergic sensitivities by history
Exclusion Criteria:
- craniofacial syndrome (ef, cleft palate)
- Use of prescription medications (except for birth control) in the 1 month prior to entry;
- Use of over-the-counter allergy medication within 2 weeks before challenge (Experiments 1, 2 only);
- Use of over-the-counter decongestants (nasal or oral) within 2 weeks before challenge (Exp 3,4 only)
- Elevated blood pressure (>140/90);
- Individuals with any pulmonary or cardiac problems, including asthma;
- Individuals who are pregnant or who are planning to become pregnant during the period of study;
- Individuals who had immunotherapy for ragweed allergy at any time (Experiment 1 only);
- Individuals who used any experimental medication or treatment within 3 months of screening;
- Individuals with extant unilateral or bilateral otitis media as documented by otoscopy or tympanometry;
- Individuals with abnormally low tympanic membrane mobility, eg Type B tympanogram;
- Individuals reporting a previous adverse experience with breathing gas mixtures containing N2O (e.g. during dental procedures);
- Individuals who have upper respiratory ("cold") symptoms or allergic rhinitis symptoms (may be rescheduled);
- Individuals with single or multiple allergic sensitivities by screening history (Experiment 2 only)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ragweed
ragweed -- 1000PNU intranasal spray
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ragweed arm only
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Experimental: histamine
5 mg intranasal spray
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histamine arm only
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Experimental: pseudoephedrine
pseudoephedrine -- 60 mg orally
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pseudoephedrine arm only
Other Names:
|
Experimental: oxymetazoline
oxymetazoline 0.05% solution intranasal spray
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oxymetazoline arm only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in trans-middle ear N2O exchange constant
Time Frame: Visit 1 and Visit 2 (Visits 2 and 3 for ragweed arm) up to approximately 3 weeks
|
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.
|
Visit 1 and Visit 2 (Visits 2 and 3 for ragweed arm) up to approximately 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cuneyt M Alper, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2013
Primary Completion (Actual)
March 22, 2019
Study Completion (Actual)
March 22, 2019
Study Registration Dates
First Submitted
August 8, 2013
First Submitted That Met QC Criteria
August 19, 2013
First Posted (Estimate)
August 20, 2013
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Otorhinolaryngologic Diseases
- Ear Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Histamine Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Histamine Agonists
- Ephedrine
- Pseudoephedrine
- Phenylephrine
- Oxymetazoline
- Histamine
Other Study ID Numbers
- PRO13040386
- 2P50DC007667-07 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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