House Dust Mite Allergy Trial In Children
- Conditions
- Allergic Rhinitis Due to House Dust MiteAllergic Rhinitis Due to Dermatophagoides FarinaeAllergic Rhinitis Due to Dermatophagoides Pteronyssinus
- Interventions
- Biological: Sublingual allergy immunotherapy tabletOther: Placebo
- Registration Number
- NCT04145219
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1460
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active treatment Sublingual allergy immunotherapy tablet HDM SLIT-tablet plus allergy and asthma rescue medication Placebo Placebo Placebo oral tablet plus allergy and asthma rescue medication
- Primary Outcome Measures
Name Time Method Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
- Secondary Outcome Measures
Name Time Method The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment) 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.
Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Total IgE Change from screening to the end of trial (after approximately 52-57 weeks of treatment) The change in total IgE was measured from screening to the end of trial.
House Dust Mite IgE-Blocking Factor Change from screening to the end of trial (after approximately 52-57 weeks of treatment) 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.
The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
House Dust Mite Specific IgE Change from screening to the end of trial (after approximately 52-57 weeks of treatment) House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
SABA Free Days During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
Rhinitis Mild Days During the Primary Efficacy Assessment Period 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP 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.
House Dust Mite Specific IgG4 Change from screening to the end of trial (after approximately 52-57 weeks of treatment) House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation
Trial Locations
- Locations (110)
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
Deaconess Clinic Allergy
🇺🇸Evansville, Indiana, United States
Multiprofile Hospital for active treatment, Department of Pediatrics
🇧🇬Gabrovo, Bulgaria
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
CHU Ste-Justine
🇨🇦Montréal, Canada
Allergy & Asthma Associates of Monmouth City
🇺🇸Little Silver, New Jersey, United States
Halton Pediatric Allergy
🇨🇦Burlington, Canada
Allergy, Asthma & Sinus Center, S.C.
🇺🇸Greenfield, Wisconsin, United States
GCP, Global Clinical Professionals
🇺🇸Saint Petersburg, Florida, United States
HNO praxis - Dr Yury Yarin
🇩🇪Dresden, Germany
Aeroallergy Research Labs of Savannah, Inc.
🇺🇸Savannah, Georgia, United States
Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology
🇧🇬Razgrad, Bulgaria
Centrum Medyczne ALL-MED
🇵🇱Kraków, Poland
Triple A Lab
🇨🇦Hamilton, Canada
Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics
🇧🇬Razgrad, Bulgaria
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
🇩🇪Frankfurt, Germany
PMG Research of McFarland Clinic
🇺🇸Ames, Iowa, United States
Allergy Partners of Western North Carolina
🇺🇸Asheville, North Carolina, United States
Multiprofile Hospital for Active Treatment, Department of Pediatrics
🇧🇬Kyustendil, Bulgaria
Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center
🇺🇦Dnipro, Ukraine
Niagara Clinical Research
🇨🇦Niagara Falls, Canada
Medical Technologies" Ltd.
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Spain
Moscow City Children's Hospital No 9
🇷🇺Moscow, Russian Federation
Hospital de Sagunto
🇪🇸Valencia, Spain
NRC Institute of Immunology
🇷🇺Moscow, Russian Federation
Alitea-Med-Medical-Center
🇧🇬Sofia, Bulgaria
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
ArsVitae Severo-Zapad LLC
🇷🇺Saint Petersburg, Russian Federation
Сurator LLC
🇷🇺Saint Petersburg, Russian Federation
City Сhildren's Сlinical Polyclinic No5
🇷🇺Perm, Russian Federation
Kinderarztpraxis Bramsche
🇩🇪Bramsche, Germany
Joel Liem Medicine Professional Corporation
🇨🇦Windsor, Canada
O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear
🇺🇦Kyiv, Ukraine
Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University
🇷🇺Krasnoyarsk, Russian Federation
I.P. Pavlov Ryazan State Medical University
🇷🇺Ryazan', Russian Federation
Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska
🇵🇱Katowice, Poland
JSC Seimos gydytojas
🇱🇹Vilnius, Lithuania
GMAP/HNO am Neckar
🇩🇪Heidelberg, Germany
Сity Children's Polyclinic No 35
🇷🇺Saint Petersburg, Russian Federation
City Children's Polyclinic No45
🇷🇺Saint Petersburg, Russian Federation
Smolensk State Medical University
🇷🇺Smolensk, Russian Federation
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Children's Clinical Hospital of Poltava Regional Council
🇺🇦Poltava, Ukraine
Regional Children's Clinical Hospital of Vinnytsia Regional Council
🇺🇦Vinnytsya, Ukraine
Scientific Medical Center for General Therapy and Pharmacology
🇷🇺Stavropol', Russian Federation
Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie
🇸🇰Košice, Slovakia
Ambulancia klinickej imunologie a alergologie
🇸🇰Šurany, Slovakia
Dnipro City Children's Municipal Clinical Hospital #2
🇺🇦Dnipro, Ukraine
Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine
🇺🇦Kyiv, Ukraine
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center
🇺🇦Lviv, Ukraine
Hospital Sant Joan de Deu
🇪🇸Esplugues De Llobregat, Spain
Hospital la Plana
🇪🇸Villarreal, Spain
Regional Children's Hospital
🇷🇺Tomsk, Russian Federation
City Children's Clinic № 16" of Kharkiv City Council
🇺🇦Kharkiv, Ukraine
City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department
🇺🇦Zaporizhzhya, Ukraine
Allergy & Asthma Specialists Medical Group and Research Center
🇺🇸Huntington Beach, California, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
Clinical Research of The Ozarks Inc
🇺🇸Warrensburg, Missouri, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
The Corvallis Clinic
🇺🇸Corvallis, Oregon, United States
Charleston Allergy & Asthma
🇺🇸Summerville, South Carolina, United States
Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse
🇧🇬Ruse, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics
🇧🇬Sofia, Bulgaria
Clinique spécialisée en allergie de la capitale
🇨🇦Québec, Canada
CHU de Montpellier - Service Pneumologie et Addictologie
🇫🇷Montpellier, France
Center of Allergy Diagnosis and Treatment
🇱🇹Vilnius, Lithuania
Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz
🇵🇱Gryfice, Poland
Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk
🇵🇱Lublin, Poland
Centrum Alergologii Teresa Hofman Sp. z o.o.
🇵🇱Poznań, Poland
IRMED Irena Wojciechowska
🇵🇱Warszawa, Poland
City Children's Hospital
🇷🇺Kolpino, Russian Federation
City Children's Polyclinic No44
🇷🇺Saint Petersburg, Russian Federation
Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases
🇺🇦Chernivtsi, Ukraine
City Children's Clinical Hospital # 19" of Kharkiv City Council
🇺🇦Kharkiv, Ukraine
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
🇺🇦Kryvyi Rih, Ukraine
State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
Regional Children Clinical Hospital, Infectious-Diagnostic Department
🇺🇦Sumy, Ukraine
Miami Clinical Research
🇺🇸Miami, Florida, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
🇺🇸San Diego, California, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Kingston General Hospital - Division of Allergy & Immunology
🇨🇦Kingston, Canada
The Montreal Children's Hospital
🇨🇦Montréal, Canada
Gordon Sussman Clinical Research, Inc.
🇨🇦North York, Canada
Hospital for Sick Children
🇨🇦Toronto, Canada
Hôpital Morvan - Service de Pédiatrie
🇫🇷Brest, France
ALFA EL, Imunoalergologická ambulancia
🇸🇰Poprad, Slovakia
North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation
🇷🇺Saint Petersburg, Russian Federation
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
🇧🇬Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Sv. Vratch and Sv.Sv. Kuzma i Damian
🇧🇬Sofia, Bulgaria
Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.
🇵🇱Rzeszow, Poland
Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz
🇵🇱Rzeszów, Poland
All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel
🇵🇱Wrocław, Poland
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
UNC Children's Raleigh
🇺🇸Raleigh, North Carolina, United States
The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital
🇺🇸Chapel Hill, North Carolina, United States
West Ashley office: Charleston Allergy & Asthma
🇺🇸Charleston, South Carolina, United States
Inlita JSC, Santara KTC
🇱🇹Vilnius, Lithuania
Diagnostic-Consultative center Ritam TR
🇧🇬Stara Zagora, Bulgaria
CD8 klinika
🇱🇹Kaunas, Lithuania
Siauliai Republican Hospital
🇱🇹Šiauliai, Lithuania
Poradnia Alergologiczna
🇵🇱Łódź, Poland
ADAC Research, PA
🇺🇸Greenville, South Carolina, United States