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.
Sublingual MM09 is being investigated as an etiological treatment for moderate-to-severe allergic rhinitis and/or rhinoconjunctivitis (as classified by ARIA), with or without mild-to-moderate controlled allergic asthma (as defined by GINA 2022), caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This prospective, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial aims to assess the efficacy of sublingual MM09 at a dose of 30,000 TU/mL compared to placebo, administered over 12 months, in participants aged 12 to 65 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
736
Sublingual spray, solution
Centro Médico Vitae
Nueve de Julio, Buenos Aires, Argentina
RECRUITINGCentro de Investigaciones Clínicas - Instituto de Especialidades de la Salud Rosario
Rosario, Santa Fe Province, Argentina
RECRUITINGCentro Respiratorio Infantil
Rosario, Santa Fe Province, Argentina
RECRUITINGFundación CIDEA
Buenos Aires, Argentina
ACTIVE_NOT_RECRUITINGHospital Italiano de Buenos Aires
Buenos Aires, Argentina
RECRUITINGCentro de Educación Medica de Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, Argentina
RECRUITINGBeijing Tongren Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Zhongshan, Guangzhou, China
NOT_YET_RECRUITINGThe Third Xiangya Hospital of Central South University
Xiangya, Hunan, China
RECRUITING...and 9 more locations
RCSMS : Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score
The RCMS corresponds to the sum of Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) and Rhinitis/Rhinoconjunctivitis Medication Score (RMS). The daily RCSMS will be calculated as RCSMS (0-6) = RSS (0-3) + RMS (0-3) Higher scores mean a worse outcome.
Time frame: last 4 weeks of IMP treatment
RSS : Rhinitis/Rhinoconjunctivitis Symptom Score
The RSS will correspond to the sum of the grade of the six Rhinitis Rhinoconjunctivitis symptoms score (SS) divided by six: RSS (0-3) = (SS1+SS2+SS3+SS4+SS5+SS6) /6. The final RSS will range from 0 to 3. Each symptom will be graded 0-3 as follows: * 0 = No symptoms (no obvious symptoms). * 1 = Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2 = Moderate (annoying but not disabling or intolerable). * 3 = Severe (disabling and/or intolerable).
Time frame: last 4 weeks of IMP treatment
RMS : Rhinitis/Rhinoconjunctivitis Medication Score
The rhinitis/rhinoconjunctivitis rescue medication will be provided to the participants with the instruction to use them according to a specific stepwise standardised procedure (See section 8.6.2): * 0= no medication. * 1= if symptoms occur, first take an oral antihistamine (desloratadine) with or without ocular antihistamine (olopatadine) * 2= if symptoms are insufficiently controlled, add intranasal corticosteroid (INS) with or without oral antihistamine (fluticasone furoate). * 3= if symptoms persist and are insufficiently controlled add an oral corticosteroid (OCS) (methylprednisolone) (with or without intranasal corticosteroid \[INS\] and antihistamine)
Time frame: last 4 weeks of IMP treatment
ASS : Asthma Symptom Score
The score is obtained by the collection on the occurrence of following asthma symptoms: * Cough * Wheezing * Shortness of breath or feeling of choking * Chest tightness Each asthma symptom will be graded as follows: * 0= No symptoms (no obvious symptoms). * 1= Mild symptoms (trivial; the symptom is clearly present but not bothersome). * 2= Moderate (annoying but not disabling or intolerable). * 3= Severe (disabling and/or intolerable). The ASS will correspond to the sum of the grades of the four asthma symptoms score (SS) divided by four: ASS (0-3) = (SS1+SS2+SS3+SS4) /4. The final score will range from 0 to 3.
Time frame: last 4 weeks of IMP treatment
AMS: Asthma Medication Score
The AMS will be scored based on the therapeutic step in which the drugs are included in the GEMA 5.0 (90) and GINA 2020 guidelines.(91) The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal." The steps of medication shown in the Figure 6 (above) correspond to the medication stepping of GEMA 5.0. In asthma participants AMS will be score as follows: * 0.5= SABA as needed. * 1= Low dose ICS with/without SABA as needed. * 1.5= Low dose ICS + LABA or medium dose ICS with/without SABA as needed. * 2= Medium dose ICS+LABA with/without SABA as needed. * 2.5= High dose ICS+LABA with/without SABA as needed. * 3= High dose ICS+LABA + systemic corticosteroids with/without SABA as needed. The AMS will correspond to the highest level of medication taken on a day. The score will range from 0 to 3.
Time frame: last 4 weeks of IMP treatment
ARSS: Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score
The ARSS ranges from 0 to 6, corresponds to the sum of RSS and ASS, and is calculated as follows: ARSS (0-6) = RSS (0-3) + ASS (0-3) Higher scores mean a worse outcome.
Time frame: last 4 week of IMP treatment
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