Phleum pratense for Allergic rhinitis (grass pollen-induced)|Allergic rhinoconjunctivitis

Inclusion criteria

• {"criterion_text":"- Age between 12 and 50 years\n- 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\n- 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\n- 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\n- Positive nasal provocation test result obtained with a maximum concentration of 1/10\n- Signed informed consent to participate in the study\n- 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\n- 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"}

Exclusion criteria

• {"criterion_text":"- 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\n- 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\n- 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).\n- Nasal septum perforation\n- 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\n- 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\n- Chronic use of medication that prevents adequate analysis and follow-up during the study: antihistamines, oral and/or parenteral corticosteroids, membrane stabilizers (cromoglycates), antidepressants\n- Refusal to participate in the trial and to sign informed consent\n- Known allergy to components of the investigational product other than the study allergen"}

Primary endpoints

• {"endpoint_text":"- The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.","definition_or_measurement_approach":"Change in Nasal Inspiratory Peak Flow (NIPF) measured using a portable nasal inspiratory flow meter; NPT considered positive if reduction in NIPF ≥ 40%. Clinical assessment by total sum of symptoms on a scoring scale (maximum 13 points)."}

Secondary endpoints

• {"endpoint_text":"- Determination of systemic and/or local adverse reactions associated with the trial, particularly those related to investigational product/placebo, and those due to the nasal provocation test or skin prick test.","definition_or_measurement_approach":"Assessment and recording of systemic and local adverse reactions during follow-up; includes those related to investigational product/placebo and procedure-related reactions."}
• {"endpoint_text":"- Rescue medication used throughout the study in relation to the investigational product/placebo (this does not include any rescue medication that may be administered after the nasal provocation test or skin prick test).","definition_or_measurement_approach":"Assessment of rescue medication use recorded during study follow-up in relation to assigned treatment; excludes rescue medication administered after NPT or skin prick test."}
• {"endpoint_text":"- Laboratory determinations of serum markers at baseline and end of study: Specific IgE to Phleum pratense and major allergens rPhl p1 + rPhl p5b., y Phleum pratense IgG4.","definition_or_measurement_approach":"Centralized laboratory determinations (Echevarne Laboratory) of specific IgE to Phleum pratense and major allergens (rPhl p1 + rPhl p5b) and Phleum pratense IgG4 at baseline and end of study."}
• {"endpoint_text":"- Phleum pratense skin prick test at baseline and end of study for comparative analysis","definition_or_measurement_approach":"Comparative analysis of skin prick test results for Phleum pratense between baseline and end of study."}
• {"endpoint_text":"- Independent analysis of each of the clinical variables included in the nasal provocation test scoring scale","definition_or_measurement_approach":"Separate analysis of each clinical variable that composes the nasal provocation test scoring scale."}

Spain

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

29

Number Of Sites

10

Number Of Participants

120

Primary sponsor

Full Name

Asac Pharmaceutical Inmunology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Advanced Outcomes Research S.L.","duties_or_roles":"1,10,12,13,5,6,7","organisation_type":"Pharmaceutical company"}