House Dust Mite Allergy Trial In Children (MATIC)

A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Dermatophagoides Farinae; Allergic Rhinitis Due to Dermatophagoides Pteronyssinus; Allergic Rhinitis Due to House Dust Mite
• Intervention / Treatment: Biological: Sublingual allergy immunotherapy tablet; Other: Placebo

Detailed Description

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.

In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

• Study Type: Interventional
• Enrollment (Actual): 1460
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital for Active Treatment, Department of Pediatrics
  • Kyustendil, Bulgaria, 2500
    • Multiprofile Hospital for Active Treatment, Department of Pediatrics
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Plovdiv, Bulgaria
    • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
  • Razgrad, Bulgaria, 7200
    • Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
  • Razgrad, Bulgaria, 7200
    • Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
  • Ruse, Bulgaria, 7002
    • Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
  • Sofia, Bulgaria, 1408
    • Sv. Vratch and Sv.Sv. Kuzma i Damian
  • Sofia, Bulgaria, 1618
    • Alitea-Med-Medical-Center
  • Stara Zagora, Bulgaria, 6000
    • Diagnostic-Consultative center Ritam TR
• Canada
  • Burlington, Canada, L7L 6W6
    • Halton Pediatric Allergy
  • Hamilton, Canada, L8S 1G5
    • Triple A Lab
  • Kingston, Canada, K7L 2V7
    • Kingston General Hospital - Division of Allergy & Immunology
  • Montréal, Canada, H3T1C5
    • CHU Ste-Justine
  • Montréal, Canada, H4A 3J1
    • The Montreal Children's Hospital
  • Niagara Falls, Canada, L2G 1J4
    • Niagara Clinical Research
  • North York, Canada
    • Gordon Sussman Clinical Research, Inc.
  • Québec, Canada, G1V 4W2
    • Clinique Spécialisée en Allergie de la Capitale
  • Toronto, Canada, M5G 1X8
    • Hospital for Sick Children
  • Windsor, Canada, N8X 2G1
    • Joel Liem Medicine Professional Corporation
• France
  • Brest, France
    • Hôpital Morvan - Service de Pédiatrie
  • Montpellier, France, 34090
    • CHU de Montpellier - Service Pneumologie et Addictologie
• Germany
  • Bramsche, Germany, 49565
    • Kinderarztpraxis Bramsche
  • Dresden, Germany, 01139
    • HNO praxis - Dr Yury Yarin
  • Frankfurt, Germany
    • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
  • Heidelberg, Germany, 68120
    • GMAP/HNO am Neckar
• Lithuania
  • Kaunas, Lithuania, LT-44191
    • CD8 Klinika
  • Vilnius, Lithuania, LT-01118
    • JSC Seimos gydytojas
  • Vilnius, Lithuania, LT-08109
    • Center of Allergy Diagnosis and Treatment
  • Vilnius, Lithuania
    • Inlita JSC, Santara KTC
  • Šiauliai, Lithuania, LT-76231
    • Siauliai Republican Hospital
• Poland
  • Gryfice, Poland, 72-300
    • Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
  • Katowice, Poland, 40-338
    • Specjalistyczna Praktyka Lekarska dr n. med. Joanna Orlicz-Widawska
  • Kraków, Poland, 30-363
    • Centrum Medyczne Plejady
  • Kraków, Poland, 30-033
    • Centrum Medyczne ALL-MED
  • Lublin, Poland, 20-050
    • Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
  • Poznań, Poland, 60-214
    • Centrum Alergologii Teresa Hofman Sp. z o.o.
  • Rzeszow, Poland, 35-612
    • Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.
  • Rzeszów, Poland
    • Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
  • Warszawa, Poland, 01-157
    • IRMED Irena Wojciechowska
  • Wrocław, Poland, 53-201
    • All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
  • Łódź, Poland, 90-141
    • Poradnia Alergologiczna
  • Łódź, Poland, 90-329
    • Poradnia Alergologiczna
• Russian Federation
  • Kolpino, Russian Federation, 196657
    • City Children's Hospital
  • Krasnoyarsk, Russian Federation, 660022
    • Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
  • Moscow, Russian Federation, 115478
    • NRC Institute of Immunology
  • Moscow, Russian Federation, 123317
    • Moscow City Children's Hospital No 9
  • Perm, Russian Federation, 614066
    • City Сhildren's Сlinical Polyclinic No5
  • Ryazan', Russian Federation, 390026
    • I.P. Pavlov Ryazan State Medical University
  • Saint Petersburg, Russian Federation, 191025
    • Medical Technologies" Ltd.
  • Saint Petersburg, Russian Federation, 191144
    • City Children's Polyclinic No44
  • Saint Petersburg, Russian Federation, 194223
    • ArsVitae Severo-Zapad LLC
  • Saint Petersburg, Russian Federation, 194291
    • North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
  • Saint Petersburg, Russian Federation, 196240
    • Сurator LLC
  • Saint Petersburg, Russian Federation
    • City Children's Polyclinic No45
  • Saint Petersburg, Russian Federation
    • Сity Children's Polyclinic No 35
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical University
  • Stavropol', Russian Federation, 355000
    • Scientific Medical Center for General Therapy and Pharmacology
  • Tomsk, Russian Federation, 634009
    • Regional Children's Hospital
• Slovakia
  • Košice, Slovakia
    • Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
  • Levice, Slovakia, 93501
    • Ambulancia klinickej imunologie a alergologie
  • Poprad, Slovakia, 05801
    • ALFA EL, Imunoalergologická ambulancia
  • Šurany, Slovakia, 94201
    • Ambulancia klinickej imunologie a alergologie
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Esplugues De Llobregat, Spain, 08950
    • Hospital Sant Joan de Déu
  • Jerez De La Frontera, Spain, 11407
    • Hospital Universitario de Jerez de la Frontera
  • Sagunto, Spain, 46520
    • Hospital de Sagunto
  • Valencia, Spain
    • Hospital de Sagunto
  • Villarreal, Spain, 12540
    • Hospital la Plana
• Ukraine
  • Chernivtsi, Ukraine, 58023
    • Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
  • Dnipro, Ukraine, 49006
    • Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center
  • Dnipro, Ukraine
    • Dnipro City Children's Municipal Clinical Hospital #2
  • Kharkiv, Ukraine, 61000
    • City Children's Clinic № 16" of Kharkiv City Council
  • Kharkiv, Ukraine, 61000
    • City Children's Clinical Hospital # 19" of Kharkiv City Council
  • Kryvyi Rih, Ukraine, 50082
    • Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
  • Kyiv, Ukraine, 03057
    • O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
  • Kyiv, Ukraine, 03680
    • State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
  • Kyiv, Ukraine, 04050
    • Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
  • Lviv, Ukraine, 79000
    • Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
  • Poltava, Ukraine, 36011
    • Children's Clinical Hospital of Poltava Regional Council
  • Sumy, Ukraine, 40031
    • Regional Children Clinical Hospital, Infectious-Diagnostic Department
  • Vinnytsya, Ukraine, 21029
    • Regional Children's Clinical Hospital of Vinnytsia Regional Council
  • Zaporizhzhya, Ukraine, 69076
    • City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Allergy & Asthma Specialists Medical Group and Research Center
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research Center, A P.C.
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Pensacola, Florida, United States, 32503
      • Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
    • Saint Petersburg, Florida, United States, 33705
      • GCP, Global Clinical Professionals
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Labs of Savannah, Inc.
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Deaconess Clinic Allergy
  • Iowa
    • Ames, Iowa, United States, 50010
      • PMG Research of McFarland Clinic
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri
    • Warrensburg, Missouri, United States, 64093
      • Clinical Research of The Ozarks Inc
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
    • Little Silver, New Jersey, United States, 07739
      • Allergy & Asthma Associates of Monmouth City
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Allergy Partners of Western North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
    • Raleigh, North Carolina, United States, 27607
      • UNC Children's Raleigh
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
    • Oklahoma City, Oklahoma, United States, 73131
      • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • The Corvallis Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • West Ashley office: Charleston Allergy & Asthma
    • Greenville, South Carolina, United States, 29607
      • ADAC research, PA
    • Summerville, South Carolina, United States, 29485
      • Charleston Allergy & Asthma
  • Texas
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma & Sinus Center, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects aged 5-11 years
• A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
• Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
• Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
• Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
• Lung function ≥ 70% of predicted value

Exclusion Criteria:

• Sensitised and regularly exposed to perennial allergens
• Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
• Asthma requiring treatment with high dose of inhaled corticosteroid
• A relevant history of systemic allergic reaction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment; HDM SLIT-tablet plus allergy and asthma rescue medication	Biological: Sublingual allergy immunotherapy tablet; For daily administration (1 tablet per day); Other Names: Acarizax; Odactra
Placebo Comparator: Placebo; Placebo oral tablet plus allergy and asthma rescue medication	Other: Placebo; For daily administration (1 tablet per day); Other Names: Placebo sublingual tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period	The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average rhinitis DSS evaluates the treatment effect based on the reduction in daily rhinitis symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DSS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	Average rhinitis DMS evaluates the treatment effect based on the reduction in daily rhinitis medication use (on a scale of 0-12). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DMS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis TCS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average rhinoconjunctivitis DSS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptom score (on a scale of 0-18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DSS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis DMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0-20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DMS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial	The overall PRQLQ score measures the effect of rhinoconjunctivitis on participant's quality of life on a scale of 0-6. Higher scores indicate worse rhinoconjunctivitis-related quality of life.	Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)
The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	The average asthma DSS evaluates the treatment effect based on the reduction in daily asthma symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 asthma DSS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
SABA Free Days During the Primary Efficacy Assessment Period	The endpoint SABA free days evaluates the treatment effect based on the reduction in SABA use. The higher the proportion of SABA free days the higher the estimated probability of a participant having a day where they didn't use SABA.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period	Average weekly number of puffs of as-needed SABA use evaluates the treatment effect based on the reduction in the use of asthma reliever medication (SABA), and is calculated as 7 times the average of the daily number of puffs of as-needed SABA use. Higher values indicate more medication use.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Rhinitis Mild Days During the Primary Efficacy Assessment Period	The endpoint rhinitis mild days evaluates the treatment effect based on days when participants have no symptoms or mild symptoms and no medication use. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis mild day.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period	The endpoint rhinitis exacerbation days evaluates the treatment effect based on days when participants have severe symptoms. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis exacerbation day.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	Average rhinitis CSMS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and/or medication use. For this endpoint, the rhinitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy & Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis CSMS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	Average rhinoconjunctivitis CSMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and/or medication use. For this endpoint, the rhinoconjunctivitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy & Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis CSMS values, the endpoint is calculated as the average of those values.	8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
House Dust Mite Specific IgE	House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
House Dust Mite Specific IgG4	House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Total IgE	The change in total IgE was measured from screening to the end of trial.	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
House Dust Mite IgE-Blocking Factor	The IgE-blocking factor assesses the effect of serum components (including IgE-blocing antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.	Change from screening to the end of trial (after approximately 52-57 weeks of treatment)

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Principal Investigator: Antje Schuster, MD, Professor of Pediatrics, Düsseldorf University Hospital

Publications and helpful links

General Publications

• Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; Allergic rhinitis; HDM
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: MT-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No