Allergy PollenNCT06957496
Phleum Pratense and Dactylis Glomerata Allergen Extracts Standardization
A study testing Allergenic extracts in people with Allergy Pollen and Allergic Reaction, run by Inmunotek S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- What is being tested?
- Allergenic extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2024to 16 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phleum Pratense and Dactylis Glomerata Allergen Extracts. Determination of the in Vivo Histamine Equivalent Prick Test Units
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
Read the detailed description
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data (age, race, and gender).
- Medical history: Time of onset of allergic rhinitis, rhinoconjunctivitis, allergic asthma and sensitizations (positive skin prick test) to allergens other than Phleum pratense and Dactylis glomerata.
- Inclusion/exclusion criteria.
- Physical examination (Cardiovascular, pulmonary, neurobiological, gastrointestinal, dermatological, other body systems and height, weight).
- Pregnancy test. Women of childbearing age will undergo a urine pregnancy test.
- Performance of prick-tests (3 concentrations of Phleum pratense and Dactylis glomerata allergenic extracts, positive control and negative control).
- Collection of blood sample (20 mL) from the subjects to create a pool of sera for the "in vitro" standardization of the allergenic extracts. Each serum sample will be stored in a tube labeled with the subject number and frozen. These serum samples will remain in the freezer until the end of the study. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro tests necessary to standardize and characterize this extract and produce its corresponding IHRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. In addition, it will be used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
- Assesment of adverse events. The trial will also include a follow-up call 72 hours after the prick tests are performed to monitor possible adverse events.
- Conditions
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- Being tested
- Allergenic extracts
- Keywords
- Allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergenic extractsOther
Also called Phleum pratense and Dactylis glomerata extracts
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Allergenic extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after allergen introduction
Secondary outcomes (2)
Adverse events registration
Registration of any adverse events that occurred during the course of the trial
Measured: Through study completion, an average of 6 months
Adverse reactions registration
Registration and documentation of any adverse reaction that occurred during the course of the trial
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start9 Dec 2024
- Primary completion13 Jan 2025
- Study completion16 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Ojeda, Principal investigator, Clínica de Asma y Alergia Dres. Ojeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957496
- Sponsor's protocol ID
- G110-STD-071
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phleum Pratense and Dactylis Glomerata Allergen Extracts. Determination of the in Vivo Histamine Equivalent Prick Test Units
- ClinicalTrials.gov ID
- NCT06957496
- Acronym / sponsor ID
- G110-STD-071
- Conditions
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- Keywords
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data (age, race, and gender).
- Medical history: Time of onset of allergic rhinitis, rhinoconjunctivitis, allergic asthma and sensitizations (positive skin prick test) to allergens other than Phleum pratense and Dactylis glomerata.
- Inclusion/exclusion criteria.
- Physical examination (Cardiovascular, pulmonary, neurobiological, gastrointestinal, dermatological, other body systems and height, weight).
- Pregnancy test. Women of childbearing age will undergo a urine pregnancy test.
- Performance of prick-tests (3 concentrations of Phleum pratense and Dactylis glomerata allergenic extracts, positive control and negative control).
- Collection of blood sample (20 mL) from the subjects to create a pool of sera for the "in vitro" standardization of the allergenic extracts. Each serum sample will be stored in a tube labeled with the subject number and frozen. These serum samples will remain in the freezer until the end of the study. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro tests necessary to standardize and characterize this extract and produce its corresponding IHRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. In addition, it will be used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
- Assesment of adverse events. The trial will also include a follow-up call 72 hours after the prick tests are performed to monitor possible adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.
| Arm | Type | Receives |
|---|---|---|
| Phleum pratense extract + Dactylis glomerata extract + positive control + negative control | Experimental | Other: Allergenic extractsThere 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergenic extractsAlso: Phleum pratense and Dactylis glomerata extractsIn 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. | Other | Phleum pratense extract + Dactylis glomerata extract + positive control + negative control |
Primary outcome
Skin induced wheal measurement
Time frame: 15 minutes after allergen introduction
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.
2 secondary outcomes
Adverse events registration
Time frame: Through study completion, an average of 6 months
Adverse reactions registration
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Ojeda principal investigator
Clínica de Asma y Alergia Dres. Ojeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergenic extracts in people with Allergy Pollen and Allergic Reaction, run by Inmunotek S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin induced wheal measurement (time frame: 15 minutes after allergen introduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.