Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day.

Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached.

Rhinoconjuntivitis

Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

allergovac polimerized (100/100)

Hospital de Zafra

Hospital de Henares

Hospital Clínico Granada

Hospital Virgen Macarena

Hospital Universitario Virgen del Rocío

A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules

Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared.

Roxall Medicina España S.A

Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma

Sensitization Against Phleum Pratense Pollen

Dose-Finding Study

Suspension for subcutaneous injection Build-up phase (day 1): 0,1mL + 0,2mL + 0,2mL s.c.injections in intervals of 30 minutes Maintenance phase: 5x single s.c. injection of 0,5mL every 4 weeks

Depigoid Phleum

Hippke, Ear-Nose-Throat specialist

Zentrum für Rhinologie und Allergie

Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma

Comparison between dosage groups: percentage of patients who need an increased amount of allergen to provoke a positive CPT at the end of the treatment (comparison slope of efficacy). It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.
According to the EMA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

Analysis of individual results for allergen amount

At the end of the study investigator and patient will give their general overall impression on the safety of the study treatment on a 4-point scale (excellent, good, moderated, unacceptable).
Results will be compared between dosage groups

AEs are recorded at the study visits (patients are questioned and the patient diary - where specific allergic symptoms should be recorded by the patients during 48hrs after each injection of IMP - is assessed by the investigator and AEs recorded in the CRF if applicable) and at any time of the study when site becomes aware of an Ae/SAE.
AE/SAE rate is compared between treatment groups (safety profile. Also rates of local and systemic reactions will be calculated.

Symptoms: - at injection site, - of the skin (not injection site), - of the nose, - of the eyes, - of the lung/respiratory system, other symptoms Symptoms documented in the diary will be judged and assessed by the investigator and - if applicable - transcribed as AE into the CRF.
Medication: Antihistaminics (eye drops, nose spray or tablet), Sultanol, oral corticosteroid and intake of other medication documented in the diary are to be transcribed to the CRF

Leti Pharma GmbH

Allergic Rhinoconjunctivitis

Suspension for Injection, Every 6 weeks for one year

Avanz Phleum pratense

Placebo

UntersuchungsZentrum für Dermatologie, Allergologie und Asthma

Avanz Phleum Pratense Maintenance Dose

ALK-Abelló A/S

The first active arm will receive a dose that is 10x less than the dose of the other arm

The first active arm will receive a dose that is 10x more than the dose of the other arm

Rhinitis, Allergic, Seasonal

Conjunctivitis, Allergic

Asthma

Immunotherapy with modified extract of P. pratense pollen

Hospital Clínico de Salamanca

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma

phleum/bronhiaalastma

A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

Avanz Phleum Pratense Maintenance Dose

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

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