Seasonal Allergic Rhinitis (SAR)NCT07588672
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
A study testing PL-14 Allergy Blocker and Ayr® Saline Nasal Mist in people with Seasonal Allergic Rhinitis (SAR) and Allergic Rhinitis, run by Polyrizon Ltd. at 5 sites in United States.
Trial summary
This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR). PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
- What is being tested?
- PL-14 Allergy Blocker and Ayr® Saline Nasal Mist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history of seasonal AR, as reported by the subject, with symptoms for more than two years and exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen/ragweed).
- Positive skin prick test (i.e., wheal ≥3 mm larger than the diluent control with erythema) or positive in vitro tests for specific IgE against allergen(s) relevant to the enrollment period at Baseline or within 12 months before enrollment .
- Age ≥ 18 years and ≤ 75 years at Screening.
- Active symptoms of seasonal AR with an rTNSS score ≥5 at randomization (based on the average rTNSS score during the Run-in Period and rounded to the nearest whole number).
- Willing and able to complete a 7-consecutive-day washout prior to the Baseline/Randomization visit, during which the subject will abstain from:
- oral or systemic H1 antihistamines, (2) topical antiallergic treatment, (3) nasal vasoconstrictors (Intermittent use of Astepro Allergy - Antihistamine (azelastine) nasal spray as rescue medication is allowed during the trial).
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- 6. Females must be non-pregnant and non-lactating, and at least one of the following must apply: i) not a woman of childbearing potential (WOCBP) (post-menopausal for ≥ 12 months and confirmed through testing of FSH levels ≥ 40 IU/L at Screening Visit); ii) WOCBP using a contraceptive method that is highly effective (a low user-dependency method OR a user-dependent method in combination with barrier method) (plus: negative urine pregnancy test and Screening Visit, within 24 hours before the first dose of study intervention and willing to have additional pregnancy tests as required throughout the study ; iii) WOCBP abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention.
- 7. Willing and able to attend all trial visits. 8. Able to read and understand study documents and follow instructions from the Investigator and study personnel during visits.
- 9. Signed IRB/EC-approved informed consent form obtained prior to any study-related procedures.
Who cannot join
- 1. Presence of active, moderate or severe symptoms of non-allergic rhinitis , acute inflammation of the nose, or paranasal sinusitis at Screening or within the 7 days prior.
- 2. Positive rapid-result COVID-19 antigen test. 3. Uncontrolled asthma under treatment with any medication other than inhaled short-acting beta-2 agonists, or with known FEV1 < 70% within the previous 6 months.
- 4. Diagnosis or symptoms of acute respiratory infection at Screening or within the previous 4 weeks.
- 5. Vaccinations: i) live vaccine(s) within 1 month prior to Screening or planned during the study; ii) killed vaccine within 1 week prior to Screening; iii) planned COVID-19 vaccine from Day -7 through Day 14.
- 6. Nasal or paranasal sinus surgery within the previous 8 weeks. 7. Long-term continuous use of inhaled or intranasal glucocorticosteroids (intermittent use is allowed).
- 8. Initiation of allergen immunotherapy within 3 months prior to Screening, or failure to have reached the maintenance phase of allergen immunotherapy at the time of enrollment, or any change in allergen immunotherapy dose or regimen within 1 month prior to Screening.
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- 9. Treatment with leukotriene receptor antagonists (at Screening or within 1 week prior) or regular/chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) at screening or within 1 week prior. Intermittent NSAID use as relief/rescue medication is allowed.
- 10. Known hypersensitivity to any constituent of the study devices (test \& control) .
- 11. Clinically significant nasal abnormalities that may interfere with proper device administration or affect nasal airflow, including but not limited to:
- Nasal septal deviation associated with clinically significant nasal obstruction, as determined by the investigator based on physical examination, and resulting in functional impairment (e.g., patient-reported difficulty in airflow).
- Nasal polyps
- Chronic rhinosinusitis (with or without nasal polyposis)
- Turbinate hypertrophy of clinical significance
- History of nasal surgery within the past 6 months
- Structural abnormalities (e.g., perforated septum, severe nasal valve collapse)
- Active nasal infection or acute sinusitis Subjects presenting with any of these conditions will be excluded from participation.
- 12. Any clinically relevant autoimmune, respiratory (especially with reduction of respiratory capacity) or cardiovascular disease, malignant tumors, bleeding disorders, autoimmune diseases, neurological disorders, or any other abnormality that, in the opinion of the Investigator, may pose a safety risk, confound the clinical performance or safety assessment, or interfere with study participation.
- 13. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to Screening.
- 14. A history of alcohol or drug abuse, within 2 years prior to screening, or current use of recreational drugs (particularly intranasal).
- 15. Planned travel to a region outside the designated pollen area for the Clinical Research Unit (CRU), as defined in the informed consent form, for ≥24 hours during the 7-day Run-in Period, OR for ≥2 consecutive days or a total of ≥3 days between the randomization visit and the follow-up phone call
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Sneeze, Wheeze & Itch Associates LLC
Normal, Illinois, 61761
Stephanie Oliver, 309-451-7509, Stephanieoliver@asthma2.com
Siri Dareen, MD
- Recruiting
Allergy Partners of NJ, PC
Ocean City, New Jersey, 07712
Caitlin Kirsch, Research Coordinator, 732.695.2555, cxkirsch@allergypartners.com
Ellen Sher, MD
- Recruiting
Biogenics Research Institute
San Antonio, Texas, 78229
Frank Jacobs, Mr., 210-614-2564, fojacobs@sbcglobal.net
Robert Jacobs, MD
- Recruiting
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Sarah Menees, RN, 314-514-8509, S.Menees@clinicalresearchcenter.com
Jost Barbara, MD
- Not yet recruiting
ClinPoint Trials
Waxahachie, Texas, 75165
Sherry Johnson Site director, RN, 972-937-1640, sjohnson@cptrials.com
Thomas Glenn Ledbetter, MD
About this study
This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR).
PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining.
Read more
This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days.
The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.
Read the detailed description
Seasonal Allergic Rhinitis (SAR) is a common chronic condition associated with symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching triggered by exposure to airborne allergens. PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act purely as a mechanical barrier in the nasal cavity, significantly reducing contact between inhaled allergens and the nasal mucosa. PL-14 Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting the alleviation of mild allergic symptoms, including itchy, runny, or congested nasal passages, triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs, and dust mites. PL-14 Allergy Blocker functions by forming a non-specific, soft gel-like physical barrier on the nasal mucosa through the rheological and mucoadhesive properties of its primary components, sodium alginate and carrageenan. Upon application, PL-14 Allergy Blocker facilitates the formation of a continuous film that adheres to the nasal cavity and entraps inhaled particles, thereby reducing exposure of the nasal epithelium to airborne allergens. This study is a prospective, randomized, single-blind, saline-controlled, parallel-group, multi-center clinical investigation evaluating the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to Ayr® Saline Nasal Mist in adults with Seasonal Allergic Rhinitis. Up to 120 participants will be enrolled at up to 8 investigational sites in the United States. Eligible participants will undergo a treatment-free run-in period followed by randomization in a 1:1 ratio to either PL-14 Allergy Blocker or saline spray. Participants will self-administer the assigned study product for up to 30 days. Efficacy assessments will primarily focus on the first 14 treatment days and will include reflective and instantaneous Total Nasal Symptom Scores (rTNSS/iTNSS), quality of life assessments using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), rescue medication use, and symptom-free days. Safety assessments will include adverse events monitoring, local nasal tolerability evaluations, nasal examinations, concomitant medication assessments, and investigator and participant global tolerability assessments throughout the study period. The total participation duration for each subject will be approximately 37 days, including screening, treatment, and follow-up.
- Being tested
- PL-14 Allergy Blocker, Ayr® Saline Nasal Mist
- Keywords
- PL-14, Allergy Blocker, Seasonal Allergic Rhinitis, Allergic Rhinitis, Nasal Spray, Pollen Allergy, TNSS, RQLQ
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL-14 Allergy BlockerDevice
Also called PL-14
PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act as a mechanical barrier in the nasal cavity to reduce contact between inhaled allergens and the nasal mucosa.
Ayr® Saline Nasal MistDevice
Ayr® Saline Nasal Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.
| Study group | Role | What they receive |
|---|---|---|
| PL-14 Allergy Blocker | Experimental | Participants assigned to this arm will self-administer PL-14 Allergy Blocker intranasally for up to 30 days according to the study Instructions for Use. Receives: Device: PL-14 Allergy Blocker |
| Ayr® Saline Nasal Mist | Active comparator | Participants assigned to this arm will self-administer Ayr® Saline Nasal Mist intranasally for up to 30 days according to the manufacturer Instructions for Use. Receives: Device: Ayr® Saline Nasal Mist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups
Assessment of the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between PL-14 Allergy Blocker and Ayr® Saline Nasal Mist during the first 14 treatment days. The rTNSS is the sum of four nasal symptom scores (rhinorrhea, nasal congestion, nasal itching and sneezing), each rated on a 0-3 scale (0 = none, 3 = severe), for a total score range of 0-12. Higher scores indicate more severe symptoms (worse outcome).
Measured: 14 treatment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Sep 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic Rhinitis (SAR)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist in a single-blind, parallel-group design. Subjects will remain assigned to the same treatment group throughout the study duratioמ
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyrizon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588672
- Sponsor's protocol ID
- PL14-CTP-01
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No