临床试验/2025-524580-21-00

2025-524580-21-00招募中3 期

A prospective, randomized, double-blind, placebo-controlled, multicentre, dose-finding clinical trial with polymerised mannan-conjugated allergoid Dactylis glomerata/Phleum pratense administered subcutaneously to patients with grass pollen-induced allergic rhinitis or rhinoconjunctivitis.

Inmunotek S.L.51 个研究点分布在 1 个国家目标入组 450 人开始时间: 2026年6月1日最近更新: 2026年5月29日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 450
试验地点: 51
主要终点: Mean daily Combined Symptom and Medication Score (CSMS, as defined in the EAACI position paper by Pfaar et al., 2014) over the peak grass pollen season 2027.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this trial is to assess the clinical efficacy of 2 concentrations (3000 mTU/mL, 9000 mTU/mL) EP-088_MG58 administered subcutaneously to participants with grass pollen-induced allergic rhinitis or rhinoconjunctivitis to determine the concentration with the best efficacy taking into account the safety and tolerability profile of both concentrations.

研究设计

分配方式: Randomized
主要目的: Treatment
盲法: Double (Subject, Investigator, Monitor)

入排标准

年龄范围: 18 years 至 64 years（18-64 Years）
接受健康志愿者: 否

入选标准

•Participants aged from 18 to 64 years,
•Laboratory tests: a. Confirmed normal renal and liver function, including non-safety-related, non-clinically relevant (≤ grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007]) deviations outside the reference ranges. Participants with deviations > grade 2 can be retested once or directly excluded. Upon normalisation (being ≤ grade 2, of the out-of-range value(s), non-clinically relevant) the participant will be eligible, b. Specific IgE against grass pollen allergens Phleum pratense (minimum CAP class 2 or higher, sIgE ≥0.7 kU/L), c. Negative pregnancy test in blood for female participants with childbearing potential (must be confirmed in urine at T1).
•Signed and dated Informed Consent Form by a legally competent participant
•Being in good physical and mental health
•Having the diagnosis of moderate/severe grass pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis due to grass pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. Being treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrolment, c. A positive skin prick test (SPT - wheal diameter ≥3 mm) to grass pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm
•Females with childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must a. Be willing to use a highly effective method of contraception: i. Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. ii. Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only (if they prevent ovulation). iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Vasectomized partner (provided, that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success). b. Have a negative pregnancy test in urine.
•Females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)
•Confirmed diagnosis of controlled allergic (extrinsic) bronchial asthma within 4 weeks before the screening visit and during the entire trial according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2025)
•For participants with obstructive or restrictive ventilation disorders (e.g. allergic [extrinsic] bronchial asthma, COPD, bronchial hyperreactivity): FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value
•Moderate to severe allergic rhinitis/rhinoconjunctivitis confirmed by CSMS (any 14 days with the highest score out of 30 days of 1.3 – 5.5 [as calculated in a pre-planned analysis]) during the screening/pre-treatment observational phase (the results will be provided to the trial sites by the CRO).

排除标准

•Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion or participation in another investigational drug study with a washout period of less than 5 half-lives of the previous investigational medicinal product prior to the screening visit of the current study
•Participants with a sensitisation to other environmental allergens as determined by a positive SPT: a. Alternaria alternata (clinically or non-clinically significant) b. House dust mites, cat dander, dog dander (if clinically significant or existing exposure)
•History of severe systemic reactions (grade III/IV) and/or anaphylaxis, including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.
•History of hypersensitivity to the excipients of the investigational medicinal product, i.e., EP-088_MG58, or placebo
•Participants with non-allergic (intrinsic) bronchial asthma
•Mild persistent to severe persistent allergic (extrinsic) bronchial asthma, which is only partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2025) within 4 weeks before the screening visit and during the treatment period
•Allergic (extrinsic) bronchial asthma, emphysema or other obstructive or restrictive ventilation disorders, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participant´s individual optimal value measured at the screening visit
•Present clinical symptoms of upper or lower respiratory tract infection in the last two weeks before screening visit S1 or T1 visit and/or exacerbation of obstructive or restrictive ventilation disorders within 4 weeks before the screening visit S1 or T1 visit
•Significant renal disease or chronic hepatic disease
•Active malignant disease (ongoing or within the five past years)
•Severe autoimmune disease
•Previous immunotherapy with grass pollen allergens within the last 5 years
•Immune defects including immunosuppression, immunopathies
•Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations
•Use of systemic immunosuppressive medications (e.g., systemic corticosteroids, methotrexate or cyclosporine A)
•General inflammatory, severe acute or chronic inflammatory diseases
•Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
•Intake of antidepressant/antipsychotic drugs with potent antihistamine properties such as tricyclic and tetracyclic antidepressants or atypical neuroleptic drugs (e.g., doxepin, amitriptyline, desipramine, imipramine, mirtazapine, quetiapine, etc.)
•Administration or planned administration of biologics (e.g., therapeutic antibodies), mast cell stabilizers or anti-leukotriene agents)
•Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor)
•Active tuberculosis
•Having any contraindication for the use of adrenaline (including hyperthyroidism)
•Ongoing immunotherapy with grass pollen allergens or any other allergens
•Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
•Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method
•Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the section Screening/Baseline Assessments and Procedures; exception made for routine control medication for asthmatic participants.
•Compliance in diary entries being <14 days during the pre-treatment observation phase of 30 days).
•Laboratory tests a. Participants with a sensitisation (CAP class 2 or higher, sIgE ≥0.7 kU/L) to Alternaria alternata (clinically or non-clinically significant), b. Clinically relevant laboratory values > grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) regarding renal/liver function at screening visit. Values can be retested once after at least 7 days. If the values remain out-of-range and (> grade 2) and clinically relevant, the participant must not be included.
•Participants with clinically relevant acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the observation period
•Being in any relationship or dependence with the sponsor, CRO and/or Investigator,
•Inability to understand instructions/trial documents,
•Participants for whom the Investigator believes that they will not comply with the protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol)
•Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
•Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible)

研究组 & 干预措施

Mannan-conjugated allergoid (polymerized) Phleum pratense and Dactylis glomerata parenteral vaccine

Test

干预措施: Mannan-conjugated allergoid (polymerized) Phleum pratense and Dactylis glomerata parenteral vaccine (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Azelastin COMOD 0,5 mg/ml Augentropfen (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Cetirizin-ratiopharm® bei Allergien Filmtabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Ebastin Aristo 10 mg Filmtabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Allegra Allergietabletten 20 mg Tabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Pricktest Negativkontrolle, Pricktestlösung (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Alternaria alternata (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Hundeepithelien (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Wiesenlieschgras (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Levocetirizin-ratiopharm 5 mg Filmtabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Desloratadin Glenmark 5 mg Tabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Alvesco 160 Mikrogramm Druckgasinhalation, Lösung (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Fexofenadin Winthrop 180 mg Filmtabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Rupatadin AL 10 mg Tabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: AVAMYS 27.5 micrograms/spray, nasal spray suspension (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Bilaxten 6 mg/ml Augentropfen, Lösung (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: EMADINE 0.5 mg/ml, eye drops, solution (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Loratadin-ratiopharm® 10 mg Tabletten (Drug)

Levocetirizin-ratiopharm 5 mg Filmtabletten, Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension, Desloratadin Glenmark 5 mg Tabletten, Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung, Alvesco 160 Mikrogramm Druckgasinhalation, Lösung, Fexofenadin Winthrop 180 mg Filmtabletten, Rupatadin AL 10 mg Tabletten, AVAMYS 27.5 micrograms/spray, nasal spray suspension, Bilaxten 6 mg/ml Augentropfen, Lösung, EMADINE 0.5 mg/ml, eye drops, solution, Loratadin-ratiopharm® 10 mg Tabletten, Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension, Azelastin COMOD 0,5 mg/ml Augentropfen, NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension, Cetirizin-ratiopharm® bei Allergien Filmtabletten, Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension, Ebastin Aristo 10 mg Filmtabletten, Allegra Allergietabletten 20 mg Tabletten, Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

Auxiliary

干预措施: Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension (Drug)

Placebo is identical in appearance an condition to the investigational medicinal product.

Placebo

干预措施: Placebo is identical in appearance an condition to the investigational medicinal product. (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Katzenepithelien (Drug)

HAL Allergy Prick Test Katzenepithelien, HAL Allergy Prick Test Gräserpollen-Mischung, HAL Allergy Pricktest Negativkontrolle, Pricktestlösung, HAL Allergy Prick Test Alternaria alternata, HAL Allergy Pricktest 10 mg/ml Pricktestlösung zur Positivkontrolle, HAL Allergy Prick Test Hundeepithelien, HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus, ALK Prick Negativ Kontrolle - Lösung für Haut-Pricktest, HAL Allergy Prick Test Wiesenlieschgras, ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest

Auxiliary

干预措施: HAL Allergy Prick Test Gräserpollen-Mischung (Drug)

结局指标

主要结局

Mean daily Combined Symptom and Medication Score (CSMS, as defined in the EAACI position paper by Pfaar et al., 2014) over the peak grass pollen season 2027.

次要结局

未报告次要终点

研究者

发起方

Inmunotek S.L.

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Miguel Casanovas

Scientific

Inmunotek S.L.

研究点 (51)

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