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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | HDM SLIT-tablet plus allergy and asthma rescue medication |
|
| Placebo | Placebo Comparator | Placebo oral tablet plus allergy and asthma rescue medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual allergy immunotherapy tablet | Biological | For daily administration (1 tablet per day) |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antje Schuster, MD | Professor of Pediatrics, Düsseldorf University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy & Asthma Specialists Medical Group and Research Center | Huntington Beach | California | 92647 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39678704 | Derived | Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan. | |
| 32548677 |
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The trial randomized 1460 participants. Two participants in the 12 SQ-HDM group were randomized in error and did not receive study treatment, hence the number of participants that started (who were randomized and treated) is 1458.
The trial randomized 1460 participants from 95 sites in 11 countries (Bulgaria, Canada, France, Germany, Lithuania, Poland, Russia, Slovakia, Spain, Ukraine, United States).
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| ID | Title | Description |
|---|---|---|
| FG000 | HDM SLIT-tablet (12 SQ-HDM) | Rhinitis/rhinoconjunctivitis rescue medication as needed, plus daily house dust mite sublingual immunotherapy tablet (HDM-SLIT tablet, 12 SQ-HDM dose). |
| FG001 | Placebo SLIT-tablet |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2021 | Mar 19, 2024 |
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Double-blind
| Placebo | Other | For daily administration (1 tablet per day) |
|
|
| 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) |
| California Allergy and Asthma Medical Group |
| Los Angeles |
| California |
| 90025 |
| United States |
| Allergy & Asthma Medical Group and Research Center, A P.C. | San Diego | California | 92123 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center | Pensacola | Florida | 32503 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | United States |
| GCP, Global Clinical Professionals | St. Petersburg | Florida | 33705 | United States |
| Aeroallergy Research Labs of Savannah, Inc. | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Deaconess Clinic Allergy | Evansville | Indiana | 47715 | United States |
| PMG Research of McFarland Clinic | Ames | Iowa | 50010 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Clinical Research of The Ozarks Inc | Warrensburg | Missouri | 64093 | United States |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
| Allergy & Asthma Associates of Monmouth City | Little Silver | New Jersey | 07739 | United States |
| Allergy Partners of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital | Chapel Hill | North Carolina | 27599 | United States |
| UNC Children's Raleigh | Raleigh | North Carolina | 27607 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Institute of Allergy & Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| The Corvallis Clinic | Corvallis | Oregon | 97330 | United States |
| West Ashley office: Charleston Allergy & Asthma | Charleston | South Carolina | 29414 | United States |
| ADAC Research, PA | Greenville | South Carolina | 29607 | United States |
| Charleston Allergy & Asthma | Summerville | South Carolina | 29485 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| Allergy, Asthma & Sinus Center, S.C. | Greenfield | Wisconsin | 53228 | United States |
| Multiprofile Hospital for active treatment, Department of Pediatrics | Gabrovo | 5300 | Bulgaria |
| Multiprofile Hospital for Active Treatment, Department of Pediatrics | Kyustendil | 2500 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4002 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD | Plovdiv | Bulgaria |
| Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics | Razgrad | 7200 | Bulgaria |
| Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology | Razgrad | 7200 | Bulgaria |
| Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse | Rousse | 7002 | Bulgaria |
| Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics | Sofia | 1407 | Bulgaria |
| Sv. Vratch and Sv.Sv. Kuzma i Damian | Sofia | 1408 | Bulgaria |
| Alitea-Med-Medical-Center | Sofia | 1618 | Bulgaria |
| Diagnostic-Consultative center Ritam TR | Stara Zagora | 6000 | Bulgaria |
| Halton Pediatric Allergy | Burlington | L7L 6W6 | Canada |
| Triple A Lab | Hamilton | L8S 1G5 | Canada |
| Kingston General Hospital - Division of Allergy & Immunology | Kingston | K7L 2V7 | Canada |
| CHU Ste-Justine | Montreal | H3T1C5 | Canada |
| The Montreal Children's Hospital | Montreal | H4A 3J1 | Canada |
| Niagara Clinical Research | Niagara Falls | L2G 1J4 | Canada |
| Gordon Sussman Clinical Research, Inc. | North York | Canada |
| Clinique spécialisée en allergie de la capitale | Québec | G1V 4W2 | Canada |
| Hospital for Sick Children | Toronto | M5G 1X8 | Canada |
| Joel Liem Medicine Professional Corporation | Windsor | N8X 2G1 | Canada |
| Hôpital Morvan - Service de Pédiatrie | Brest | France |
| CHU de Montpellier - Service Pneumologie et Addictologie | Montpellier | 34090 | France |
| Kinderarztpraxis Bramsche | Bramsche | 49565 | Germany |
| HNO praxis - Dr Yury Yarin | Dresden | 01139 | Germany |
| Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin | Frankfurt | Germany |
| GMAP/HNO am Neckar | Heidelberg | 68120 | Germany |
| CD8 klinika | Kaunas | LT-44191 | Lithuania |
| Siauliai Republican Hospital | Šiauliai | LT-76231 | Lithuania |
| JSC Seimos gydytojas | Vilnius | LT-01118 | Lithuania |
| Center of Allergy Diagnosis and Treatment | Vilnius | LT-08109 | Lithuania |
| Inlita JSC, Santara KTC | Vilnius | Lithuania |
| Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz | Gryfice | 72-300 | Poland |
| Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska | Katowice | 40-338 | Poland |
| Centrum Medyczne ALL-MED | Krakow | 30-033 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Poradnia Alergologiczna | Lodz | 90-141 | Poland |
| Poradnia Alergologiczna | Lodz | 90-329 | Poland |
| Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk | Lublin | 20-050 | Poland |
| Centrum Alergologii Teresa Hofman Sp. z o.o. | Poznan | 60-214 | Poland |
| Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o. | Rzeszów | 35-612 | Poland |
| Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz | Rzeszów | Poland |
| IRMED Irena Wojciechowska | Warsaw | 01-157 | Poland |
| All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel | Wroclaw | 53-201 | Poland |
| City Children's Hospital | Kolpino | 196657 | Russia |
| Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University | Krasnoyarsk | 660022 | Russia |
| NRC Institute of Immunology | Moscow | 115478 | Russia |
| Moscow City Children's Hospital No 9 | Moscow | 123317 | Russia |
| City Сhildren's Сlinical Polyclinic No5 | Perm | 614066 | Russia |
| I.P. Pavlov Ryazan State Medical University | Ryazan | 390026 | Russia |
| Medical Technologies" Ltd. | Saint Petersburg | 191025 | Russia |
| City Children's Polyclinic No44 | Saint Petersburg | 191144 | Russia |
| ArsVitae Severo-Zapad LLC | Saint Petersburg | 194223 | Russia |
| North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation | Saint Petersburg | 194291 | Russia |
| Сurator LLC | Saint Petersburg | 196240 | Russia |
| City Children's Polyclinic No45 | Saint Petersburg | Russia |
| Сity Children's Polyclinic No 35 | Saint Petersburg | Russia |
| Smolensk State Medical University | Smolensk | 214019 | Russia |
| Scientific Medical Center for General Therapy and Pharmacology | Stavropol | 355000 | Russia |
| Regional Children's Hospital | Tomsk | 634009 | Russia |
| Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie | Košice | Slovakia |
| Ambulancia klinickej imunologie a alergologie | Levice | 93501 | Slovakia |
| ALFA EL, Imunoalergologická ambulancia | Poprad | 05801 | Slovakia |
| Ambulancia klinickej imunologie a alergologie | Šurany | 94201 | Slovakia |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | 08950 | Spain |
| Hospital Universitario de Jerez de la Frontera | Jerez de la Frontera | 11407 | Spain |
| Hospital de Sagunto | Sagunto | 46520 | Spain |
| Hospital de Sagunto | Valencia | Spain |
| Hospital la Plana | Villarreal | 12540 | Spain |
| Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases | Chernivtsi | 58023 | Ukraine |
| Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center | Dnipro | 49006 | Ukraine |
| Dnipro City Children's Municipal Clinical Hospital #2 | Dnipro | Ukraine |
| City Children's Clinic № 16" of Kharkiv City Council | Kharkiv | 61000 | Ukraine |
| City Children's Clinical Hospital # 19" of Kharkiv City Council | Kharkiv | 61000 | 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 | 50082 | Ukraine |
| O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear | Kyiv | 03057 | Ukraine |
| State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine | Kyiv | 03680 | Ukraine |
| Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine | Kyiv | 04050 | Ukraine |
| Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center | Lviv | 79000 | Ukraine |
| Children's Clinical Hospital of Poltava Regional Council | Poltava | 36011 | Ukraine |
| Regional Children Clinical Hospital, Infectious-Diagnostic Department | Sumy | 40031 | Ukraine |
| Regional Children's Clinical Hospital of Vinnytsia Regional Council | Vinnytsia | 21029 | Ukraine |
| City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department | Zaporizhzhya | 69076 | Ukraine |
| Derived |
| 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. |
Rhinitis/rhinoconjunctivitis rescue medication as needed, plus daily placebo sublingual immunotherapy tablet (Placebo SLIT-tablet).
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| COMPLETED | Completed IMP |
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| NOT COMPLETED |
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|
All randomized and treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | HDM SLIT-tablet (12 SQ-HDM) | Rhinitis/rhinoconjunctivitis rescue medication as needed, plus daily house dust mite sublingual immunotherapy tablet (HDM-SLIT tablet, 12 SQ-HDM dose). |
| BG001 | Placebo SLIT-tablet | Rhinitis/rhinoconjunctivitis rescue medication as needed, plus daily placebo sublingual immunotherapy tablet (Placebo SLIT-tablet). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants had to be 5-11 years old at randomization | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Allergy history | All participants had a medical history of HDM allergic rhinitis or rhinoconjunctivitis. However, since 1 participant in the 12 SQ-HDM group had 'rhinitis' entered in the wrong eCRF form, the data incorrectly suggests that 1 participant did not have rhinitis/rhinoconjunctivitis even though they did. | Count of Participants | Participants |
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| Baseline sensitisations | Count of Participants | Participants |
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| Asthma status at baseline | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Participants in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations | Posted | Mean | Standard Error | score on a scale | Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment) |
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| Secondary | 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. | Participants with asthma in the full analysis set with observations in the primary efficacy period | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants with asthma in the full analysis set with observations in the primary efficacy period | Posted | Number | 95% Confidence Interval | Probability (%) of a SABA free day | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants with asthma in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | weekly number of puffs | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants with asthma in the full analysis set with observations in the primary efficacy period | Posted | Number | 95% Confidence Interval | Probability (%) of a rhinitis mild day | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period | Posted | Number | 95% Confidence Interval | Probability (%) of a rhinitis exace. day | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | 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. | Participants in the full analysis set with observations in the primary efficacy period. | Posted | Mean | Standard Error | score on a scale | 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP |
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| Secondary | House Dust Mite Specific IgE | House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation | Participants from Canada and Poland in the full analysis set with observations | Posted | Mean | Standard Deviation | log10 transformed kU/L | Change from screening to the end of trial (after approximately 52-57 weeks of treatment) |
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| Secondary | House Dust Mite Specific IgG4 | House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation | Participants from Canada and Poland in the full analysis set with observations | Posted | Mean | Standard Deviation | log10 transformed mg/L | Change from screening to the end of trial (after approximately 52-57 weeks of treatment) |
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| Secondary | Total IgE | The change in total IgE was measured from screening to the end of trial. | Participants from Canada and Poland in the full analysis set with observations | Posted | Mean | Standard Deviation | log10 transformed kU/L | Change from screening to the end of trial (after approximately 52-57 weeks of treatment) |
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| Secondary | 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. | Participants from Canada and Poland in the full analysis set with observations | Posted | Mean | Standard Deviation | unitless | Change from screening to the end of trial (after approximately 52-57 weeks of treatment) |
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Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (from V1 to TC3 (telephone call 3), for approximately 54-59 weeks).
Treatment emergent AEs (TEAEs) are displayed (these were AEs starting on/after time of first IMP and no later than 7 days after last day of IMP). For the first 28 days of treatment, the presence/absence of 15 specific symptoms, identified as local side effects of sublingual immunotherapy (solicited events), were captured in an eDiary. Solicited events were evaluated by the investigator and reported in the eCRF as AEs as per their discretion. TEAEs from the eCRF are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HDM SLIT-tablet (12 SQ-HDM) | Rhinitis/rhinoconjunctivitis rescue medication and asthma controller/reliever medication as needed, plus daily house dust mite sublingual allergy immunotherapy tablet (HDM-SLIT tablet, 12 SQ-HDM dose). | 0 | 727 | 16 | 727 | 608 | 727 |
| EG001 | Placebo SLIT-tablet | Rhinitis/rhinoconjunctivitis rescue medication and asthma controller/reliever medication as needed, plus daily placebo sublingual allergy immunotherapy tablet (Placebo SLIT-tablet). | 0 | 731 | 6 | 731 | 534 | 731 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis norovirus | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pseudomonas bronchitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hallucinations, mixed | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral pruritus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Tooth loss | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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No publication can be made before the primary publication. PI shall provide Sponsor (S) with a copy of any publication or presentation 60 days before submission/public disclosure. S can require changes or non-publication of the article, if appropriate. Upon S request, the PI must delay the publication, presentation or public disclosure for an additional 120 days to permit S to apply for a patent application. Any other public statements regarding the trial requires prior written consent from S.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations Strategy | ALK-Abelló A/S | +45 4574 7576 | clinicaltrials@alk.net |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2023 | Mar 19, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| American Indian or Alaska Native |
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| Multiple |
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| Other |
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| United States |
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| Ukraine |
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| Poland |
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| Slovakia |
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| Bulgaria |
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| France |
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| Lithuania |
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| Germany |
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| Russia |
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| Spain |
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| House dust mite and others |
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