Middle Ear DiseasePhase 1NCT01925729
TransMEM Gas Exchange -- Project 1, Aim 2
A Phase 1 study testing ragweed, histamine and pseudoephedrine in people with Middle Ear Disease and Nasal Allergy, run by Cuneyt M. Alper at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle Ear Disease, Nasal Allergy
- What is being tested?
- ragweed, histamine and pseudoephedrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 22 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Middle Ear Physiology Laboratory, University of PIttsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Middle Ear Disease, Nasal Allergy
- Being tested
- ragweed, histamine, pseudoephedrine, Oxymetazoline
- Keywords
- middle ear, allergy, nose
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ragweedBiological
ragweed arm only
histamineBiological
histamine arm only
pseudoephedrineDrug
Also called Sudafed
pseudoephedrine arm only
OxymetazolineDrug
Also called Afrin
oxymetazoline arm only
| Study group | Role | What they receive |
|---|---|---|
| ragweed | Experimental | ragweed -- 1000PNU intranasal spray Receives: Biological: ragweed |
| histamine | Experimental | 5 mg intranasal spray Receives: Biological: histamine |
| pseudoephedrine | Experimental | pseudoephedrine -- 60 mg orally Receives: Drug: pseudoephedrine |
| oxymetazoline | Experimental | oxymetazoline 0.05% solution intranasal spray Receives: Drug: Oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 and Visit 2 (Visits 2 and 3 for ragweed arm) up to approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study start1 Oct 2013
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Ear DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuneyt M. Alper
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925729
- Sponsor's protocol ID
- PRO13040386
- Other IDs
- 2P50DC007667-07
- Status last verified
- Feb 2020
- First submitted
- 8 Aug 2013
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Ear Pressure Regulation in Health and Disease -- Gas Supply, Demand and Middle Ear Gas Balance -- Specific Aim 2
- ClinicalTrials.gov ID
- NCT01925729
- Acronym / sponsor ID
- PRO13040386
- Conditions
- Middle Ear Disease, Nasal Allergy
- Keywords
- middle ear, allergy, nose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cuneyt M. AlperUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ragweed | Experimental | Biological: ragweedragweed -- 1000PNU intranasal spray |
| histamine | Experimental | Biological: histamine5 mg intranasal spray |
| pseudoephedrine | Experimental | Drug: pseudoephedrinepseudoephedrine -- 60 mg orally |
| oxymetazoline | Experimental | Drug: Oxymetazolineoxymetazoline 0.05% solution intranasal spray |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ragweedragweed arm only | Biological | ragweed |
| histaminehistamine arm only | Biological | histamine |
| pseudoephedrineAlso: Sudafedpseudoephedrine arm only | Drug | pseudoephedrine |
| OxymetazolineAlso: Afrinoxymetazoline arm only | Drug | oxymetazoline |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuneyt M Alper, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ragweed, histamine and pseudoephedrine in people with Middle Ear Disease and Nasal Allergy, run by Cuneyt M. Alper at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.