Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
1 other identifier
interventional
120
0 countries
N/A
Brief 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 mucosa and reduce contact between airborne allergens and the nasal lining. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
Study Completion
Last participant's last visit for all outcomes
September 30, 2027
May 15, 2026
May 1, 2026
1 year
May 9, 2026
May 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
14 treatment days
Study Arms (2)
PL-14 Allergy Blocker
EXPERIMENTALParticipants assigned to this arm will self-administer PL-14 Allergy Blocker intranasally for up to 30 days according to the study Instructions for Use.
Ayr® Saline Nasal Mist
ACTIVE COMPARATORParticipants assigned to this arm will self-administer Ayr® Saline Nasal Mist intranasally for up to 30 days according to the manufacturer Instructions for Use.
Interventions
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 Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.
Eligibility Criteria
You may qualify if:
- 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:
- (1) 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).
- \. 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.
- \. 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.
- \. Signed IRB/EC-approved informed consent form obtained prior to any study-related procedures.
You may not qualify if:
- \. 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.
- \. 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.
- \. Diagnosis or symptoms of acute respiratory infection at Screening or within the previous 4 weeks.
- \. 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.
- \. Nasal or paranasal sinus surgery within the previous 8 weeks. 7. Long-term continuous use of inhaled or intranasal glucocorticosteroids (intermittent use is allowed).
- \. 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.
- \. 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.
- \. Known hypersensitivity to any constituent of the study devices (test \& control) .
- \. 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Polyrizon Ltd.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2026
First Posted
May 15, 2026
Study Start (Estimated)
July 15, 2026
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share