Phase
Condition
Common Cold
Allergy
Eye Disorders/infections
Treatment
Placebo subcutaneous
10,000 MG01 +10,000 T521
30,000 MG01 +10,000 T521
Clinical Study ID
Ages 12-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent.
Aged between 12 and 65, both genders
Positive suggestive clinical history of intermittent or persistent moderate tosevere rhinitis /rhinoconjunctivitis according to ARIA classification, with orwithout moderate intermittent or persistent asthma,according to GEMA 5.0, due tograss and cupressaceae pollen.
Subjects with a positive skin prick-test (wheal size >5 mm diameter) to astandardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus,Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of themolecular components of the mixture and to a cupressaceae extract. In addition, thelargest diameter of the papules must be greater than or equal to that of thehistamine.
Specific IgE > 3,5 KU/L , against grass (preferably Phleum pratense) andcupressaceae pollen (InmunoCAP® o Immulite).
Women of childbearing age (from menarche) must present a urine pregnancy test with anegative result at the time of joining the trial.
Women of childbearing potential participating in the trial, should commit to usingan appropriate method of contraception. Medically acceptable methods ofcontraception are intrauterine devices placed at least 3 months in advance, surgicalsterilization (for example, tubal ligation), barrier methods, or the use of oralcontraceptives.
Subjects capable of complying with the dosing regimen.
Subjects who own a smartphone for symptom registration and medication.
Subjects with a negative prick test to coestational pollens. In the case specificIgE is available, the result should be <3,5 kU/L and without relevant symptomatology
Subjects with a negative prick test to other aeroallergens (dust mites, epitheliumsand fungus). In the case specific IgE is available, the result should be <3,5 kU/Land without relevant symptomatology.
Exclusion
Exclusion Criteria:
Subjects with positive prick test to other aeroallergens except for sensitisation toepithelia with occasional exposure and symptoms.
Subjects with positive prick test to other aeroallergens except for sensitisation topollen noncoseasonal with cupressus or grasses.
Subjects who have received prior immunotherapy in the preceding 5 years for any ofthe allergens tested or a cross-reactive allergen or are currently receivingimmunotherapy with any allergen.
Subjects in which immunotherapy may be subject to an absolute generalcontraindication according to the criteria of the Immunotherapy Committee of theSpanish Society of Allergy and Clinical Immunology and the European Allergy andClinical Immunology Immunotherapy Subcommittee.
Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatmentat the time of inclusion in the trial. Likewise, subjects with intermittent orpersistent rhinitis / rhinoconjunctivitis with severe symptoms in which thesuspension of oral or systemic antihistamine treatment is contraindicated.
Subjects who have previously had a severe secondary reaction during the prick testdiagnostic skin test.
Subjects treated with beta-blockers.
Clinically unstable subjects at the time of inclusion in the trial (acute asthmaticexacerbation, respiratory infection, febrile process, acute urticaria, etc.).
Subjects with active chronic urticaria, severe dermographism, severe atopicdermatitis, sunburn, active psoriasis with lesions in areas where skin tests will beperformed, or a history of hereditary angioedema.
Subjects who have any pathology in which adrenaline administration iscontraindicated (hyperthyroidism, HTN, heart disease, etc.).
Subjects with any other disease not related to moderate rhinoconjunctivitis orasthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperatedpatients, kidney disease,).
Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or witha diagnosis of immunodeficiencies.
Subject whose condition prevents from offering cooperation and/ or who has severepsychiatric disorders.
Subjects with a known allergy to components of the investigational medicinal productother than the allergen.
Subjects with lower respiratory diseases other than asthma such as emphysema orbronchiectasis.
Subjects who are direct relatives of the researchers.
Pregnant or lactating women.
Study Design
Study Description
Connect with a study center
Hospital Recoletas Felipe Ii
Valladolid, Castilla Y León 47003
SpainActive - Recruiting
Hospital Universitario Principe de Asturias
Alcalá De Henares, Comunidad De Madrid 28806
SpainCompleted
Clínica Ojeda
Madrid, Comunidad De Madrid 28006
SpainActive - Recruiting
Clínica Privada Dres Ojeda
Madrid, Comunidad De Madrid 28006
SpainActive - Recruiting
Hospital Cruz Roja Madrid
Madrid, Comunidad De Madrid 28003
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Comunidad De Madrid 28222
SpainSite Not Available
Cedt de Tarancon
Tarancon, Cuenca 16400
SpainSite Not Available
Cedt de Tarancón
Tarancón, Cuenca 16400
SpainActive - Recruiting
Hospital U. Fundación Alcorcón
Alcorcón, Madrid 28922
SpainActive - Recruiting
Clínica Privada Murcia
Murcia, Región De Murcia 30006
SpainSite Not Available
Fundación Hospital Sant Pere Claver
Barcelona, 08004
SpainSite Not Available
Clínica privada Burgos
Burgos, 09004
SpainSite Not Available
Hospital Universitario de Burgos
Burgos, 09006
SpainActive - Recruiting
Hospital General de Villalba
Collado-Villalba, 28400
SpainSite Not Available
Clinica privada
León, 24003
SpainSite Not Available
CAP José Marva
Madrid, 28020
SpainSite Not Available
Centro Médico Iza (Clínica Privada Madrid)
Madrid, 28760
SpainActive - Recruiting
Centro médico Saluddia
Madrid, 28522
SpainActive - Recruiting
Clínica Privada
Madrid, 28034
SpainSite Not Available
Clínica Subiza
Madrid, 28006
SpainSite Not Available
Hospital Carlos III (antiguo CAP José Marva)
Madrid, 28029
SpainSite Not Available
Hospital Infanta Elena
Madrid, 28342
SpainSite Not Available
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainSite Not Available
Clinica privada
Palencia, 34001
SpainActive - Recruiting
Consulta Privada
Palencia, 34001
SpainCompleted
Clinica privada
Pamplona, 31006
SpainSite Not Available
Hospital Clínico de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital General Universitario de Segovia
Segovia, 40002
SpainSite Not Available
Clinica Privada Soria
Soria, 42005
SpainSite Not Available
Clínica Privada
Zaragoza, 50004
SpainSite Not Available
Clínica Privada Zaragoza
Zaragoza, 50004
SpainSite Not Available
Hospital Nuestra Señora de Sonsoles
Ávila, 05071
SpainSite Not Available
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