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Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
Sponsor: Inmunotek S.L.
Summary
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
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With/Without Mild to Moderate Asthma Sensitized to Olive and Grass Pollen
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2021-06-14
Completion Date
2027-01
Last Updated
2025-05-07
Healthy Volunteers
No
Interventions
10,000 MG01 + 10,000 T517
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
30,000 MG01 + 10,000 T517
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 Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
Placebo
The same solution and presentation as the active treatment, but without active ingredients
Locations (32)
Cedt de Tarancón
Tarancón, Cuenca, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Centro Médico Iza
Tres Cantos, Madrid, Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain
Hospital Clínico Universitario Virgen de Arrixaca
El Palmar, Murcia, Spain
Private Practice
Albacete, Spain
Hospital Ntra. Sra. de Sonsoles
Ávila, Spain
Clinica Dermatologica Y Alergia
Badajoz, Spain
Hospital Quironsalud Clideba
Badajoz, Spain
Hospital Universitario Dexeus
Barcelona, Spain
Clínica privada Barcelona
Barcelona, Spain
Hospital General Universitario Ciudad Real
Ciudad Real, Spain
Hospital Quironsalud Córdoba
Córdoba, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitari Santa María
Lleida, Spain
Private practice
Madrid, Spain
Hospital Universitario Cruz Roja
Madrid, Spain
Clínica de Asma y Alergia en Madrid | CLÍNICA OJEDA
Madrid, Spain
Clínica Subiza
Madrid, Spain
Hospital Carlos Iii
Madrid, Spain
Hospital Universitario Rey Juan Carlos
Madrid, Spain
Hospital Quirónsalud Málaga
Málaga, Spain
Private Practice
Málaga, Spain
Private Practice
Murcia, Spain
Private Practice
Palencia, Spain
Hospital Universitario Infanta Cristina
Parla, Spain
Clínica privada Sevilla
Seville, Spain
Hospital Virgen Del Rocío
Seville, Spain
Hospital Viamed Santa Ángela de La Cruz
Seville, Spain
Private Practice
Toledo, Spain
Hospital Recoletas Felipe Ii
Valladolid, Spain