TransMEM Gas Exchange -- Project 1, Aim 2

NCT01925729 | Completed Phase 1

• 2 other identifiers: PRO130403862P50DC007667-07
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Middle Ear Disease; Nasal Allergy

Keywords

middle ear; allergy; nose

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 1 and Visit 2 (Visits 2 and 3 for ragweed arm) up to approximately 3 weeks

Study Arms (4)

ragweed

EXPERIMENTAL

ragweed -- 1000PNU intranasal spray

Biological: ragweed

histamine

EXPERIMENTAL

5 mg intranasal spray

Biological: histamine

pseudoephedrine

EXPERIMENTAL

pseudoephedrine -- 60 mg orally

Drug: pseudoephedrine

oxymetazoline

EXPERIMENTAL

oxymetazoline 0.05% solution intranasal spray

Drug: Oxymetazoline

Interventions

ragweed BIOLOGICAL

ragweed arm only

ragweed

histamine BIOLOGICAL

histamine arm only

histamine

pseudoephedrine DRUG

pseudoephedrine arm only

Also known as: Sudafed

pseudoephedrine

Oxymetazoline DRUG

oxymetazoline arm only

Also known as: Afrin

oxymetazoline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cuneyt M. Alper: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Middle Ear Physiology Laboratory, University of PIttsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Histamine; Pseudoephedrine; Oxymetazoline

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines

Study Officials

• Cuneyt M Alper, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 20, 2013
• Study Start: October 1, 2013
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

US (1)