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TransMEM Gas Exchange -- Project 1, Aim 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01925729
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Cuneyt M. Alper, University of Pittsburgh

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Middle Ear Disease Nasal Allergy Biological: ragweed Biological: histamine Drug: pseudoephedrine Drug: Oxymetazoline Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific Aim 2
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ragweed
ragweed -- 1000PNU intranasal spray
 Biological: ragweed
ragweed arm only
Experimental: histamine
5 mg intranasal spray
 Biological: histamine
histamine arm only
Experimental: pseudoephedrine
pseudoephedrine -- 60 mg orally
 Drug: pseudoephedrine
pseudoephedrine arm only
Other Name: Sudafed
Experimental: oxymetazoline
oxymetazoline 0.05% solution intranasal spray
 Drug: Oxymetazoline
oxymetazoline arm only
Other Name: Afrin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925729


Locations
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United States, Pennsylvania
Middle Ear Physiology Laboratory, University of PIttsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Cuneyt M. Alper
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Cuneyt M Alper, MD University of Pittsburgh
More Information
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Responsible Party: Cuneyt M. Alper, Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01925729    
Other Study ID Numbers: PRO13040386
2P50DC007667-07 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Keywords provided by Cuneyt M. Alper, University of Pittsburgh:
middle ear
allergy
nose
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases
Phenylephrine
Pseudoephedrine
Oxymetazoline
Ephedrine
Histamine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
 Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents
Histamine Agonists
Histamine Agents