Non-allergic RhinitisPhase 3NCT05093478
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
A Phase 3 study testing Intranasal capsaicin and topical lidocaine in people with Non-allergic Rhinitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-allergic Rhinitis
- What is being tested?
- Intranasal capsaicin and topical lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 30 Nov 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic rhinitis
Who cannot join
- Active smoker
- Anatomic source of nasal symptoms
- Chronic rhinosinusitis or other nasal infection
- History of sinonasal malignancy
- Pregnancy or lactation
- Use of medication affecting nasal function (topical steroids, topical anticholinergics, oral antihistamines) in the previous 4 weeks
- Use or abuse of nasal decongestants.
- Positive skin prick test for allergic rhinitis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.
- Conditions
- Non-allergic Rhinitis
- Being tested
- Intranasal capsaicin, topical lidocaine
- Keywords
- rhinorrhea, congestion, sneezing, itching
- Medical subject headings
- Common Cold, Rhinorrhea, Sneezing, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal capsaicinDrug
Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.
topical lidocaineDrug
The nose will be pre-treated with topical lidocaine 15 minutes before each application
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Intranasal capsaicin; Drug: topical lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: baseline
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 4 weeks post treatment
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 12 weeks post treatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: baseline
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 4 weeks post treatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 12 weeks post treatment
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: baseline
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 4 weeks post treatment
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 12 weeks post treatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: baseline
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 4 weeks post treatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Measured: 12 weeks post treatment
Change in Maximum Optical Density Determined Via Optical Rhinometry
Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.
Measured: baseline, immediately post first treatment on Day 1
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Measured: baseline
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Measured: 4 weeks post treatment
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Measured: 12 weeks post treatment
Maximum Optical Density Determined Via Optical Rhinometry
Measured: 12 weeks post treatment
Secondary outcomes (1)
Change in Local Immunoglobulin E (IgE) Level
The IgE levels will be obtained from the brush biopsy of the inferior turbinates. Change from baseline in local Immunoglobulin E (IgE) level after 12 weeks post treatment. Data reported is the 12 weeks post treatment value minus the baseline value.
Measured: baseline, 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start10 Sep 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-allergic RhinitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngic Allergy
- Responsible party
- Principal investigator, Kunal R. Shetty, The University of Texas Health Science Center, Houston
- Investigators
- Kunal R Shetty, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093478
- Sponsor's protocol ID
- HSC-MS-19-0333
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2021
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
- ClinicalTrials.gov ID
- NCT05093478
- Acronym / sponsor ID
- HSC-MS-19-0333
- Conditions
- Non-allergic Rhinitis
- Keywords
- rhinorrhea, congestion, sneezing, itching
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngic Allergy
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Intranasal capsaicin, Drug: topical lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic rhinitis
Key exclusion criteria (8 listed)
- Active smoker
- Anatomic source of nasal symptoms
- Chronic rhinosinusitis or other nasal infection
- History of sinonasal malignancy
- Pregnancy or lactation
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 |
|---|---|---|
| Intranasal capsaicinIntranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour. | Drug | Treatment |
| topical lidocaineThe nose will be pre-treated with topical lidocaine 15 minutes before each application | Drug | Treatment |
Primary outcome
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
Time frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
Time frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
Time frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
Time frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Change in Maximum Optical Density Determined Via Optical Rhinometry
Time frame: baseline, immediately post first treatment on Day 1
Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
Time frame: baseline
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time frame: 4 weeks post treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time frame: 12 weeks post treatment
Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Maximum Optical Density Determined Via Optical Rhinometry
Time frame: 12 weeks post treatment
1 secondary outcome
Change in Local Immunoglobulin E (IgE) Level
Time frame: baseline, 12 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kunal R Shetty, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal capsaicin and topical lidocaine in people with Non-allergic Rhinitis, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 8 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 20 Dec 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline (time frame: baseline). The study lists 17 primary outcomes in all. 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 20 Dec 2024.