Allergy PollenNCT05533385
Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.
A study testing Allergenic extract in people with Allergy Pollen and Allergic Reaction, run by Inmunotek S.L. at 1 site in Spain.
Trial summary
The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP). 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 extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2023to 22 Jan 2024
- 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 must live in a geographical area where allergic problems caused by Juniperus oxycedrus and Cupressus arizonica are relevant.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Juniperus oxycedrus and Cupressus arizonica.
- A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
- The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
- Age: Between 18 and 64 years old.
- Both sexes.
- Subjects must be able to give informed consent.
- Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of enrollment in the trial.
Who cannot join
- Subjects should not be excluded in terms of low or high sensitivity to Juniperus oxycedrus and Cupressus arizonica.
- Subjects outside the age range.
- Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Juniperus oxycedrus and Cupressus arizonica extracts.
- Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
- Subjects under treatment with ß-blockers.
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- Subjects clinically unstable (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 viral infection by herpes simplex 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, HTA, cardiopathy, etc.).
- States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
- Pregnant women or women at risk of pregnancy and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Read the detailed description
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data.
- Clinical history.
- Inclusion/exclusion criteria.
- Physical examination.
- Pregnancy test.
- Performance of prick-tests (3 concentrations of Juniperus oxycedrus and Cupressus arizonica allergenic extract, positive control and negative control).
- Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract.
- 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.
- Evaluation of adverse events.
- Conditions
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- Being tested
- Allergenic extract
- 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 extractOther
Also called Allergenic Juniperus oxycedrus and Cupressus arizonica extract
In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.
| Study group | Role | What they receive |
|---|---|---|
| Extract J. oxycedrus + extract C. arizonica + positive control + negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10 mg/mL) and the negative control, with prick test.
Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 µg/mL Receives: Other: Allergenic extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the induced papule on the skin
Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.
Measured: 15 minutes
Adverse reactions
Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start10 Oct 2023
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
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.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- 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, open-label, non-randomized trial, with no control group of subjects.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Subiza, DM, Principal investigator, Clinica Subiza, centro de asma y alergia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533385
- Sponsor's protocol ID
- T521-STD-044
- Other IDs
- 2020-005389-32
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
- ClinicalTrials.gov ID
- NCT05533385
- Acronym / sponsor ID
- T521-STD-044
- Conditions
- Allergy Pollen, Allergic Reaction, Allergic Skin Reaction
- Keywords
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 9 Sep 2022 (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 objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed description
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data.
- Clinical history.
- Inclusion/exclusion criteria.
- Physical examination.
- Pregnancy test.
- Performance of prick-tests (3 concentrations of Juniperus oxycedrus and Cupressus arizonica allergenic extract, positive control and negative control).
- Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract.
- 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.
- Evaluation of 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, open-label, non-randomized trial, with no control group of subjects.
| Arm | Type | Receives |
|---|---|---|
| Extract J. oxycedrus + extract C. arizonica + positive control + negative control | Experimental | Other: Allergenic extractThere is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10 mg/mL) and the negative control, with prick test. Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 µg/mL |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must live in a geographical area where allergic problems caused by Juniperus oxycedrus and Cupressus arizonica are relevant.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Juniperus oxycedrus and Cupressus arizonica.
- A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
- The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
- Age: Between 18 and 64 years old.
Key exclusion criteria (12 listed)
- Subjects should not be excluded in terms of low or high sensitivity to Juniperus oxycedrus and Cupressus arizonica.
- Subjects outside the age range.
- Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Juniperus oxycedrus and Cupressus arizonica extracts.
- Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
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 extractAlso: Allergenic Juniperus oxycedrus and Cupressus arizonica extractIn each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm. | Other | Extract J. oxycedrus + extract C. arizonica + positive control + negative control |
Primary outcome
Size of the induced papule on the skin
Time frame: 15 minutes
Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.
Adverse reactions
Time frame: 30 minutes
Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).
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 19 Sep 2024.
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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.
Javier Subiza, DM principal investigator
Clinica Subiza, centro de asma y alergia
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 extract 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 8 inclusion and 12 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 19 Sep 2024. 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?
Size of the induced papule on the skin (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 19 Sep 2024.