RecruitingPhase 3NCT04891237

Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

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


Sponsor

Inmunotek S.L.

Enrollment

180 participants

Start Date

Jun 14, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating the effectiveness and safety of allergy immunotherapy (allergy shots or drops) targeting both grass pollen and olive pollen for people who are allergic to both. The goal is to see if this combined treatment reduces allergy symptoms over time. **You may be eligible if...** - You are between 12 and 65 years old - You have confirmed moderate-to-severe allergic rhinitis or rhinoconjunctivitis (runny nose, sneezing, itchy eyes) caused by both grass and olive pollen - Your skin prick test and blood IgE test confirm allergies to both grass and olive pollen - You do not have allergies to other common airborne allergens (like dust mites, mold, or pet dander) - Women of childbearing age must use effective contraception and have a negative pregnancy test **You may NOT be eligible if...** - You are allergic to multiple other airborne allergens in addition to grass and olive - You have had allergy immunotherapy in the past 5 years - You have severe or poorly controlled asthma - You are taking beta-blockers - You had a serious reaction to allergy skin tests in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICAL10,000 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

BIOLOGICAL30,000 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

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04891237


Related Trials