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Diagnostic Accuracy of Parietaria judaica Pollen Extract (SPT‑RX) in a Skin Prick Test Drug Combination for Adults with Allergic Rhinitis and Controlled Mild Asthma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves people who have long‑standing rhinitis or rhinoconjunctivitis, conditions that cause a runny or itchy nose and eyes, and who may also have mild‑to‑moderate asthma that is well controlled. These symptoms are triggered by allergens that cause IgE mediated allergies. To evaluate the allergy status, a series of solutions containing specific pollen extracts are used: parietaria judaica pollen extract (code SPT‑RX‑PAR), phleum pratense pollen extract (SPT‑RX‑PHL), betula pendula pollen extract (SPT‑RX‑BET), dermatophagoides pteronyssinus extract (SPT‑RX‑DPT), and olea europaea pollen extract (SPT‑RX‑OLE). Each solution is applied to the skin in a small amount for a diagnostic test.

The purpose of the study is to assess how well these extracts identify allergic versus non‑allergic individuals by measuring the test’s sensitivity and specificity. Participants will attend a clinic visit where a tiny amount of each solution is placed on the forearm and gently pricked into the skin using a skin prick test method; a control drop without allergen is also used. After a few minutes the size of any raised, red bump (called a wheal) is measured, and the results are compared with the person’s medical history to determine accuracy. The study follows participants for a short period after the test to complete the assessments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit for skin prick testing

    Upon joining the study, attend the designated clinic on the scheduled date for the diagnostic procedure.

    The purpose of this visit is to perform a skin prick test using the study solutions.

  2. Step 2

    Skin prick test administration

    A small amount (40 µl) of each allergen extract solution is placed on the skin and a sterile needle lightly punctures the surface.

    The extracts used are parietaria judaica pollen, phleum pratense pollen, betula pendula pollen, dermatophagoides pteronyssinus, and olea europaea pollen.

    The route is intraepidermal (into the outer skin layer).

  3. Step 3

    Observation and measurement

    After the puncture, wait for approximately 15 minutes while the skin reaction develops.

    The size of the raised bump (wheal) is measured in millimetres; a diameter of 3 mm or more is considered a positive result.

  4. Step 4

    Result recording and follow‑up

    The measurements are recorded by the study staff and used to determine sensitivity and specificity of each extract.

    No further medication is given; the patient may leave the clinic after the observation period.

Who can join the trial?

10 criteria

  • Signed a written informed consent form that is dated before any study-specific examinations are performed.
  • Are a male or female aged between 18 and 65 years at the time the consent form is signed.
  • Show a positive reaction (a raised bump of at least 3 mm) on a skin prick test using a positive control (histamine, a substance that normally causes a small skin reaction), and a negative reaction (bump less than 2 mm) on a skin prick test using a negative control (saline solution).
  • Can follow study instructions, keep a simple diary, and are expected to cooperate with the study staff.
  • Have ongoing nasal or eye allergy symptoms (rhinitis/rhinoconjunctivitis), with mild‑to‑moderate asthma that is well‑controlled or no asthma, caused by the study allergens for at least 2 years if the allergen is seasonal, or at least 1 year if the allergen is present year‑round.
  • Have a previous diagnosis of IgE‑mediated (type I) allergy to a study allergen, confirmed by:
    • a symptom score of 1 or higher on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the period of highest exposure,
    • a positive skin prick test (bump at least 3 mm) with a standard allergen extract,
    • a blood test showing specific IgE level of class 3 or higher (value ≥ 3.50 kU/L).
    • If you have never had allergy symptoms (“true non‑allergic” patient), you must be either non‑atopic (no general allergy tendency) or only sensitized to allergens not being studied, proven by:
      • a negative skin prick test (bump less than 3 mm) for all study allergens, and
      • a blood test showing specific IgE level below class 1 (value < 0.35 kU/L) for those allergens.

Who cannot join the trial?

17 criteria

  • Using medicines that could change the results of the skin prick test (the test that checks for allergies).
  • Having skin problems such as easy skin bruising from pressure (dermographism), eczema (atopic dermatitis), hives (urticaria), a rare condition with many mast cells in the skin (cutaneous mastocytosis), or having a tattoo where the test would be applied.
  • Being unable to receive adrenaline (a medication used for severe allergic reactions) because of heart disease, very high blood pressure, an overactive thyroid, or glaucoma.
  • Any other medical reason that makes a skin prick test unsafe.
  • Being unlikely to follow the study rules and visits.
  • Having a close personal or financial relationship with the study sponsor or investigators, being legally unable to give consent, or being living in a government institution.
  • Having serious mental health problems or substance abuse that would prevent cooperation with the study.
  • Being enrolled in another clinical trial at the same time.
  • If you are considered “truly non‑allergic,” having a hidden sensitivity to any allergen that can react with the test allergens (cross‑reactivity).
  • For people with asthma: having severe, partly controlled, or uncontrolled asthma, a lung function test result (FEV1) of 80 % or less of the normal value, or a known high tendency for the airways to narrow (bronchial hyperreactivity).
  • Being allergic to any inactive ingredient (excipients) in the test solutions.
  • Receiving or having received allergy shots (allergen immunotherapy) for the test allergens or related allergens.
  • Having a serious overall disease affecting the liver, kidneys, heart, metabolism, an autoimmune disease, a weakened immune system, or an active infection or inflammation of the breathing passages.
  • Taking medicines called beta‑blockers.
  • Having taken or currently taking an anti‑IgE antibody medication (such as Omalizumab) or a cancer‑related checkpoint inhibitor.
  • Having a medical history that puts you at high risk for a severe allergic reaction called anaphylaxis.
  • Being pregnant or breastfeeding.
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Investigated drugs

  • SPT-RX-PAR

    is a skin‑prick test solution that contains pollen from the plant Parietaria judaica. In the trial, a tiny amount of this solution is placed on the skin and a small prick is made. If a person is allergic to this pollen, a skin reaction (like a small bump) will appear, helping doctors identify an IgE‑mediated allergy to Parietaria pollen.

  • SPT-RX-PHL

    is a skin‑prick test solution that contains pollen from Timothy grass (Phleum pratense). During the test, a small drop is applied to the skin and pricked. A positive skin reaction shows that the person has an IgE‑mediated allergy to Timothy grass pollen.

  • SPT-RX-BET

    is a skin‑prick test solution that contains pollen from the silver birch tree (Betula pendula). The solution is used in the same way as other skin‑prick tests: a drop is placed on the skin and lightly pricked. If the person is allergic to birch pollen, a skin bump will develop, indicating an IgE‑mediated birch allergy.

  • SPT-RX-DPT

    is a skin‑prick test solution that contains extract from the dust mite Dermatophagoides pteronyssinus. A small amount is applied to the skin and pricked. A reaction at the test site shows that the person has an IgE‑mediated allergy to this common house dust mite.

  • SPT-RX-OLE

    is a skin‑prick test solution that contains pollen from the olive tree (Olea europaea). The test involves placing a drop on the skin and making a tiny prick. If the person is allergic to olive pollen, a skin reaction will appear, indicating an IgE‑mediated olive allergy.

What is already known about the treatment

  • SPT-RX-PAR

    This skin‑prick test solution contains Parietaria judaica pollen extract and is applied by placing a tiny drop on the skin and puncturing it (intraepidermal use). It is an established diagnostic agent that is routinely used in allergy clinics and documented in medical literature. The test helps identify people with allergic rhinitis, rhinoconjunctivitis or mild asthma caused by Parietaria pollen. It works by exposing the skin to the allergen, which triggers an IgE‑mediated reaction that produces a visible wheal, and it is classified as a diagnostic allergen extract (ATC V04CL).

  • SPT-RX-PHL

    This skin‑prick test solution contains Phleum pratense (timothy grass) pollen extract and is applied by placing a small drop on the skin and pricking it (intraepidermal use). It is a widely accepted diagnostic product used in allergy testing and described in current medical references. The test is used to detect allergic rhinitis, rhinoconjunctivitis or mild asthma caused by timothy grass pollen. It works by introducing the allergen to the skin, provoking an IgE‑mediated wheal response, and it belongs to the class of diagnostic allergen extracts (ATC V04CL).

  • SPT-RX-BET

    This skin‑prick test solution contains Betula pendula (birch) pollen extract and is administered by placing a drop on the skin and performing a small puncture (intraepidermal use). It is an established diagnostic reagent that is commonly used in allergy practice and reported in the literature. The test helps diagnose allergic rhinitis, rhinoconjunctivitis or mild asthma triggered by birch pollen. It works by exposing the skin to the birch allergen, causing an IgE‑mediated wheal if the person is sensitized, and it is classified as a diagnostic allergen extract (ATC V04CL).

  • SPT-RX-DPT

    This skin‑prick test solution contains Dermatophagoides pteronyssinus (house dust mite) extract and is applied by dropping a small amount on the skin and pricking it (intraepidermal use). It is a well‑known diagnostic tool that is routinely employed in allergy clinics and referenced in current medical publications. The test is used to identify allergic rhinitis, rhinoconjunctivitis or mild asthma caused by dust‑mite exposure. It works by presenting the mite allergen to the skin, which triggers an IgE‑mediated reaction and a visible wheal, and it falls under the diagnostic allergen extract category (ATC V04CL).

  • SPT-RX-OLE

    This skin‑prick test solution contains Olea europaea (olive tree) pollen extract and is given by placing a tiny drop on the skin and making a small puncture (intraepidermal use). It is an established diagnostic product widely used in allergy testing and described in the medical literature. The test assists in diagnosing allergic rhinitis, rhinoconjunctivitis or mild asthma related to olive pollen. It works by exposing the skin to the olive pollen allergen, producing an IgE‑mediated wheal when sensitization is present, and it is classified as a diagnostic allergen extract (ATC V04CL).

Investigated diseases

  • Allergic rhinitis

    A condition in which the lining of the nose becomes inflamed after exposure to allergens such as pollen or dust mites. It causes sneezing, a runny or blocked nose, and itching. The symptoms may appear seasonally when specific plants release pollen, or they can occur year‑round with indoor allergens. Continuous exposure can lead to persistent nasal irritation and increased symptom frequency.

  • Allergic rhinoconjunctivitis

    This disorder combines nasal inflammation with inflammation of the eye surface due to allergic triggers. Patients experience typical nasal symptoms together with itchy, watery, and red eyes. It can be triggered by the same seasonal or perennial allergens that cause allergic rhinitis. Ongoing exposure often makes the eye and nose symptoms flare together and become more chronic.

  • Mild-to-moderate asthma

    A chronic disease where the airways become inflamed and narrow, leading to wheezing, coughing, and shortness of breath. Symptoms are usually triggered by allergens, cold air, or exercise. In the mild‑to‑moderate range, episodes may occur intermittently and are often linked to exposure levels. Repeated triggers can increase the frequency of breathing difficulties over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524676-32-00Protocol codePT-3A2HEstimated enrolment1 140 patientsSponsorROXALL Medizin GmbH

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