Home › Trials › NCT04891237

Evaluating a treatment for allergies to grass and olive pollen

A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen

Phase 3 Interventional Inmunotek S.L. · NCT04891237

This study is testing a new allergy treatment for people aged 12 to 65 who have reactions to grass and olive pollen to see if it can help reduce their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorInmunotek S.L. Industry-sponsored
Drugs / interventionsimmunotherapy
Locations32 sites (Tarancón, Cuenca and 31 other locations)
Trial IDNCT04891237 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of subcutaneous immunotherapy in patients aged 12 to 65 with mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, who are sensitized to grass and olive pollen. The study will involve 180 participants and will last for one year, during which they will receive either the active treatment or a placebo. The primary outcome measure will be the change in clinical symptoms as assessed by a standardized scale.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 65 with confirmed inhalational allergies to grass and olive pollen, experiencing mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma.

Not a fit: Patients with severe asthma or those not sensitized to grass or olive pollen may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce allergy symptoms and improve quality of life for patients suffering from grass and olive pollen allergies.

How similar studies have performed: Previous studies have shown positive outcomes with similar immunotherapy approaches for allergic rhinitis, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject who has signed the informed consent.
2. Subjects of both sexes aged between 12 and 65 years.
3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value \> 3,5 KU / L.
6. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.
7. Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.
8. Subjects capable of complying with the dosage regimen.
9. Subjects who have a smartphone to record symptoms and medication.
10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology
11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology

Exclusion Criteria:

1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
4. Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.
6. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
7. Subjects under treatment with ß-blockers.
8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).
12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
13. Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders.
14. Subjects with a known allergy to other investigational drug components other than the allergen.
15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
16. Subjects who are direct relatives of the researchers.
17. Pregnant or lactating women.

Where this trial is running

Tarancón, Cuenca and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rhinitis, AllergicRhinoconjunctivitisAsthma, AllergicRhinitis/ RhinoconjunctivitisMild to moderate asthmaAllergyGrassesOlea
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.