RecruitingPhase 3NCT04435990

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae


Sponsor

Inmunotek S.L.

Enrollment

150 participants

Start Date

Oct 6, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of allergy immunotherapy (allergy shots or drops) for people who are allergic to dust mites, a common cause of allergic rhinitis and asthma. **You may be eligible if...** - You are between 12 and 65 years old - You have a confirmed allergy to dust mites causing moderate-to-severe runny nose, sneezing, or asthma symptoms - Allergy testing confirms dust mite sensitivity **You may NOT be eligible if...** - You received allergy immunotherapy for dust mites, molds, or animal dander in the past 5 years - You have a condition that makes immunotherapy unsafe (such as severe or uncontrolled asthma) - You are pregnant - You are taking beta-blocker medications 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 MM09

Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL

BIOLOGICAL30,000 MM09

Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL

BIOLOGICALPlacebo subcutaneous

The same solution and presentation as the active treatment, but without active ingredients.


Locations(32)

Hospital Provincial de Conxo

Santiago de Compostela, A Coruña, Spain

IMED Elche

Elche, Alicante, Spain

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Clinica Tecma

Valencia, Alzira, Spain

Clinica Virgen del Rosario

Algeciras, Cadiz, Spain

Hospital HLA Jerez Puerta Sur

Jerez de la Frontera, Cádiz, Spain

Hospital Dr. Peset

Valencia, España, Spain

Hospital General Universitario Santa Maria de Rosell

Cartagena, Murcia, Spain

Hospital Rivera Povisa

Vigo, Pontevedra, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario San Juan de Alicante

Alicante, Spain

Clínica Dermatológica y Alergia

Badajoz, Spain

Hospital Quironsalud Clideba

Badajoz, Spain

Hospital Sant Pere Claver

Barcelona, Spain

Clínica Corachan

Barcelona, Spain

Hospital Universitari Dexeus

Barcelona, Spain

Cenvi Medic

Barcelona, Spain

Allergocenter

Barcelona, Spain

Clinica privada

Bilbao, Spain

Centro Médico ASISA Dr. Lobatón

Cadiz, Spain

Centro Médico Puerto

Cadiz, Spain

Hospital Quiron Salud Córdoba

Córdoba, Spain

Hospital Polusa

Lugo, Spain

Clinica privada

Málaga, Spain

Hospital Comarcal de Melilla

Melilla, Spain

Clinica Privada

Murcia, Spain

Alergocantabria

Santander, Spain

Hospital Quiron Infanta Luisa

Seville, Spain

Clinica Lanuza

Valencia, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

Clinica IMED

Valencia, Spain

Hospital de Sagunto

Valencia, Spain

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NCT04435990


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