RecruitingPhase 3NCT04898283

Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.

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


Sponsor

Inmunotek S.L.

Enrollment

180 participants

Start Date

May 31, 2021

Study Type

INTERVENTIONAL

Conditions

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.


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 drops or shots) targeting both cypress tree pollen and grass pollen in people allergic to both. The goal is to reduce allergy symptoms like sneezing, runny nose, and itchy eyes during the pollen season. **You may be eligible if...** - You are between 12 and 65 years old - You have confirmed moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by both cypress and grass pollen - Your skin prick test and blood IgE test confirm allergies to both cypress and grass pollen - You do not have significant allergies to other common airborne allergens - Women of childbearing age must use effective contraception and have a negative pregnancy test - You have a smartphone to record daily symptoms **You may NOT be eligible if...** - You are allergic to multiple other environmental allergens (dust mites, mold, pets) - You have received allergy immunotherapy in the past 5 years - You have severe or poorly controlled asthma (breathing test FEV1 below 70%) - You are taking beta-blocker medications - You have autoimmune disease, significant organ disease, or a serious psychiatric disorder - You are pregnant or breastfeeding 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.

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Interventions

BIOLOGICAL10,000 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

BIOLOGICAL30,000 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.

OTHERPlacebo 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

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NCT04898283


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