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Dose determination study of Phleum pratense allergenic extract for immunotherapy treatment, administered via sublingual route, standardized in TBU/mL.
EU CTIS ID: 2025-522730-31-00
What this study is testing
To determine the most effective dose of the allergen extract of grass polen (Phleum pratense), for immunotherapeutic treatment administered via sublingual route, standardized in TBU/mL, without compromising patient safety.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 12 and 50 years
- Diagnosis of allergic rhinitis with/without conjunctivitis, with/without associated asthma. In patients with associated asthma at the time of recruitment, lung function must be FEV1 > 70% of predicted and FVC > 80% of predicted
- Positive skin prick test to Phleum pratense or to a homologous grass allergen routinely used at the site, with a mean wheal diameter at least 5 mm greater than the negative control. The grass allergen used will be the one customarily employed by each site according to its clinical protocol. The skin test will be considered valid if performed no more than 6 months prior to inclusion in the study
- Specific IgE determination to Phleum pratense or to the homologous allergen used at the site of at least 0.70 kU/L. This determination will be considered valid if performed no more than 6 months prior to inclusion. This value must be corroborated by the centralized study determination
- Positive nasal provocation test result obtained with a maximum concentration of 1/10
- Signed informed consent to participate in the study
You likely can't join if
- Sensitization (skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites, or any other allergenic source depending on each participating site’s geographic location) that may interfere with the patient’s clinical evolution during follow-up. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid. In the case of sensitization to animal dander, inclusion may be accepted provided that the patient has no habitual contact with such animals and that there is no possibility of this occurring during follow-up. Sensitization to pollens that overlap the grass season will not be considered an exclusion criterion, except when there is concomitant sensitization to Cupressus arizonica, ash, plane tree, and/or oak (considering results from the last 6 months or from the prick test performed in the study with supplied allergens) whose pollen seasons occur during the patient follow-up period
- Nasal hyperreactivity, defined as a ≥15% reduction in Peak Nasal Inspiratory Flow (PNIF/PFIN) or an increase of 3 points in the symptom score compared with baseline during the nasal provocation test
- Recent nasal/oral surgery (within 6 months or less; in the case of dental extractions, dental implants, or similar procedures, within the last 2 months).
- Nasal septum perforation
- Partially controlled or uncontrolled bronchial asthma according to GINA criteria. Exclusion criteria will include: FEV1 ≤ 70% of predicted and FVC ≤ 80% of predicted and Continuous use of asthma medication included in GINA levels 3, 4, or 5
- Usual contraindications for allergen immunotherapy: Active or controlled neoplastic disease diagnosed within the last 5 years, Acute psychiatric pathology limiting the patient’s normal daily activity, Pregnancy and lactation
See the full eligibility criteria
Who can join
- Age between 12 and 50 years
- Diagnosis of allergic rhinitis with/without conjunctivitis, with/without associated asthma. In patients with associated asthma at the time of recruitment, lung function must be FEV1 > 70% of predicted and FVC > 80% of predicted
- Positive skin prick test to Phleum pratense or to a homologous grass allergen routinely used at the site, with a mean wheal diameter at least 5 mm greater than the negative control. The grass allergen used will be the one customarily employed by each site according to its clinical protocol. The skin test will be considered valid if performed no more than 6 months prior to inclusion in the study
- Specific IgE determination to Phleum pratense or to the homologous allergen used at the site of at least 0.70 kU/L. This determination will be considered valid if performed no more than 6 months prior to inclusion. This value must be corroborated by the centralized study determination
- Positive nasal provocation test result obtained with a maximum concentration of 1/10
- Signed informed consent to participate in the study
- In women of childbearing potential (considered fertile from menarche to post-menopause unless sterilized due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), certainty of not being pregnant at study entry, which will be confirmed by a negative urine pregnancy test. In addition, a new pregnancy test must be performed at the end of treatment to confirm absence of pregnancy
- No prior specific immunotherapy with Phleum pratense extracts or any related pollen within the last 5 years, and not receiving concomitant specific immunotherapy with Phleum pratense or any other allergen during the study period
What rules you out
- Sensitization (skin prick test and/or specific IgE) to perennial allergens (animal dander, environmental fungi, storage mites, or any other allergenic source depending on each participating site’s geographic location) that may interfere with the patient’s clinical evolution during follow-up. Tests and determinations performed within a maximum of 6 months prior to the inclusion visit will be considered valid. In the case of sensitization to animal dander, inclusion may be accepted provided that the patient has no habitual contact with such animals and that there is no possibility of this occurring during follow-up. Sensitization to pollens that overlap the grass season will not be considered an exclusion criterion, except when there is concomitant sensitization to Cupressus arizonica, ash, plane tree, and/or oak (considering results from the last 6 months or from the prick test performed in the study with supplied allergens) whose pollen seasons occur during the patient follow-up period
- Nasal hyperreactivity, defined as a ≥15% reduction in Peak Nasal Inspiratory Flow (PNIF/PFIN) or an increase of 3 points in the symptom score compared with baseline during the nasal provocation test
- Recent nasal/oral surgery (within 6 months or less; in the case of dental extractions, dental implants, or similar procedures, within the last 2 months).
- Nasal septum perforation
- Partially controlled or uncontrolled bronchial asthma according to GINA criteria. Exclusion criteria will include: FEV1 ≤ 70% of predicted and FVC ≤ 80% of predicted and Continuous use of asthma medication included in GINA levels 3, 4, or 5
- Usual contraindications for allergen immunotherapy: Active or controlled neoplastic disease diagnosed within the last 5 years, Acute psychiatric pathology limiting the patient’s normal daily activity, Pregnancy and lactation
- Chronic use of medication that prevents adequate analysis and follow-up during the study: antihistamines, oral and/or parenteral corticosteroids, membrane stabilizers (cromoglycates), antidepressants
- Refusal to participate in the trial and to sign informed consent
- Known allergy to components of the investigational product other than the study allergen
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.