Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorInmunotek S.L.
About this trial
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis / rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive
Eligibility criteria
Qualifiers
Subject who has signed the informed consent.
Subjects of both sexes aged between 12 and 65 years.
Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent
Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.
Disqualifiers
Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms
Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive
Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.
Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
Trial design
Treatments tested in this trial
- 10,000 MG01 + 10,000 T517
- 30,000 MG01 + 10,000 T517
- Placebo
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov