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Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.
Sponsor: Inmunotek S.L.
Summary
A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.
Official title: Prospective, Multicentre, Doubleblind, Placebo-controlled RCT to Evaluate Efficacy and Safety With SC Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitised to Grasses and Cupressaceae
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2021-05-31
Completion Date
2026-10
Last Updated
2025-05-13
Healthy Volunteers
No
Interventions
10,000 MG01 +10,000 T521
Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
30,000 MG01 +10,000 T521
Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupressaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
Placebo subcutaneous
The same solution and presentation as the active treatment, but without active ingredients
Locations (27)
Hospital Recoletas Felipe Ii
Valladolid, Castille and León, Spain
Cedt de Tarancón
Tarancón, Cuenca, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital U. Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Cruz Roja Madrid
Madrid, Madrid, Spain
Clínica Privada Dres Ojeda
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Clínica Privada Murcia
Murcia, Murcia, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, Spain
Fundación Hospital Sant Pere Claver
Barcelona, Spain
Clínica privada Burgos
Burgos, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital General de Villalba
Collado Villalba, Spain
Clinica privada
León, Spain
Clínica Subiza
Madrid, Spain
Hospital Carlos III (antiguo CAP José Marva)
Madrid, Spain
Clínica Privada
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Infanta Elena
Madrid, Spain
Centro médico Saluddia
Madrid, Spain
Centro Médico Iza (Clínica Privada Madrid)
Madrid, Spain
Consulta Privada
Palencia, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital General Universitario de Segovia
Segovia, Spain
Clinica Privada Soria
Soria, Spain
Clínica Privada
Zaragoza, Spain