New allergy blocker spray could offer Drug-Free relief

NCT ID NCT07588672

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new nasal spray called PL-14 Allergy Blocker in about 120 adults with seasonal allergies. Unlike regular allergy sprays, PL-14 is drug-free and works by forming a gel-like barrier in the nose to block allergens. The study compares it to a simple saline spray over 30 days to see if it reduces symptoms like sneezing and stuffiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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). 2. 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 . 3. Age ≥ 18 years and ≤ 75 years at Screening. 4. 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). 5. 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). 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. Exclusion Criteria: * 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. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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