Phleum Pratense and Dactylis Glomerata Allergen Extracts Standardization

NCT06957496 | Completed

• 1 other identifier: G110-STD-071
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the concentration of each allergen extract (Phleum pratense and Dactylis glomerata) that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution. The standardization procedure is carried out according to the Aas Method as specified in the guideline developed by the Nordic Council on Medicines

Conditions

Allergy Pollen; Allergic Reaction; Allergic Skin Reaction

Keywords

Allergy

Outcome Measures

Primary Outcomes (1)

• Skin induced wheal measurement

  Measure of the area (mm\^2) of the induced wheal on the skin upon applying each of the 3 concentrations of each allergenic extract (Phleum pratense and Dactylis glomerata), as well as those induced by positive (histamine) and negative controls, through the prick test.

  15 minutes after allergen introduction

Secondary Outcomes (2)

• Adverse events registration

  Through study completion, an average of 6 months

• Adverse reactions registration

  Through study completion, an average of 6 months

Study Arms (1)

Phleum pratense extract + Dactylis glomerata extract + positive control + negative control

EXPERIMENTAL

There is only one treatment arm. In each subject, one drop of each of the three concentrations of both allergenic extracts, along with the positive (histamine) and negative (saline solution) controls, will be applied to each subject. Phleum pratense: 100, 10 and 1 µg/mL Dactylis glomerata: 100, 10 and 1 µg/mL

Other: Allergenic extracts

Interventions

Allergenic extracts OTHER

In each subject, a drop of each of the 3 concentrations of the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results.

Also known as: Phleum pratense and Dactylis glomerata extracts

Phleum pratense extract + Dactylis glomerata extract + positive control + negative control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who have signed and dated informed consent form.
• Female or male aged 18 to 64 years, both included.
• Subjects must reside in a geographical area where allergic problems caused by Phleum pratense and Dactylis glomerata are relevant.
• Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Phleum pratense and Dactylis glomerata.
• A positive prick-test (mean wheal diameter ≥ 3 mm) with extracts of the same allergens and/or presence of specific IgE against complete extract or any molecular component to the allergenic sources.
• The area of the wheal obtained with 10 mg/mL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.
• The area of the wheal obtained with negative control should be \< 7 mm², which corresponds to a mean wheal diameter \< 3 mm.
• Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.
• Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.

You may not qualify if:

• Subjects outside the age range.
• Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with the extracts of Phleum pratense and Dactylis glomerata.
• Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
• Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.
• Subjects on treatment with ß-blockers.
• Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2).
• Clinically unstable subjects (acute asthma, febrile, etc.).
• Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
• Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.
• Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
• States in which the subject is unable to offer cooperation and severe psychiatric disorders.
• Pregnant or potentially pregnant women and breastfeeding women.
• Subjects with known phenol allergy.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (1)

Clínica de Asma y Alergia Dres. Ojeda

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Pedro Ojeda

  Clínica de Asma y Alergia Dres. Ojeda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: May 4, 2025
• Study Start: December 9, 2024
• Primary Completion: January 13, 2025
• Study Completion: January 16, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)