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RecruitingPhase 3NCT07348302

Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df

Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and/or Df

Sponsor

Inmunotek S.L.

Enrollment

736 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

RhinoconjunctivitisRhinitis

Summary

The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are: Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a sublingual immunotherapy (SLIT) — drops or tablets placed under the tongue — for people with allergic rhinitis (hay fever-like symptoms) and/or mild-to-moderate asthma caused by house dust mites. The goal is to desensitize the immune system so it overreacts less to dust mite allergens. **You may be eligible if...** - You are 12–65 years old - You have had allergic nose/eye symptoms or mild-moderate controlled asthma triggered by house dust mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae) for at least 1 year - You have a positive skin prick test confirming the dust mite allergy - You have a smartphone to log symptoms **You may NOT be eligible if...** - You have severe or uncontrolled asthma - You have another major allergy that also causes significant symptoms - You are pregnant or have a positive pregnancy test at enrollment - You have other conditions that prevent safe or compliant participation 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

BIOLOGICALAllergen Immunotherapy Extract

Sublingual spray, solution

Locations(19)

Centro Médico Vitae

Nueve de Julio, Buenos Aires, Argentina

Centro de Investigaciones Clínicas - Instituto de Especialidades de la Salud Rosario

Rosario, Santa Fe Province, Argentina

Centro Respiratorio Infantil

Rosario, Santa Fe Province, Argentina

Fundación CIDEA

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Centro de Educación Medica de Investigaciones Clinicas "Norberto Quirno" (CEMIC)

Buenos Aires, Argentina

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangzhou, China

The First Affiliated Hospital, Sun Yat-sen University

Zhongshan, Guangzhou, China

The Third Xiangya Hospital of Central South University

Xiangya, Hunan, China

Changzhou Third People's Hospital

Changzhou, Jiangsu, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Tongji Hospital Tongji Medical College of HUST

Tongji, Wuhan, China

Union Hospital Tongji Medical College of HUST

Huangzhou, China

Unidade de Local de Saúde de Santo António, E.P.E.

Porto, Portugal

ULS Lezíria- Hospital Distrital de Santarém

Santarém, Portugal

Hospital IMED Benidorm

Benidorm, Alicante, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

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NCT07348302

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