Mite Asthma Pediatric Immunotherapy Trial (MAPIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03654976|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Allergic Asthma Due to Dermatophagoides Farinae Allergic Asthma Due to Dermatophagoides Pteronyssinus Allergic Rhinitis Due to House Dust Mite||Biological: HDM SLIT-tablet Other: Placebo||Phase 3|
The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations.
Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis.
Finally, quality of life (QoL) for subjects and caregivers will be measured.
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 2 years. Subjects will receive a written asthma action plan.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel-group|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Active treatment
Subject's ICS or ICS/LABA background medication plus HDM SLIT-tablet
Biological: HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Placebo Comparator: Placebo
Subject's ICS or ICS/LABA background medication plus placebo oral tablet
Placebo sublingual tablet, for daily administration (1 tablet per day)
- Clinically relevant asthma exacerbations [ Time Frame: Through study completion, approximately 24 months ]Annualised rate of clinically relevant asthma exacerbations
- Nightly awakenings [ Time Frame: Through study completion, approximately 24 months ]Proportion of days with nocturnal awakenings due to asthma requiring SABA duing eDiary recording
- SABA use [ Time Frame: Through study completion, approximately 24 months ]Average daily dose of SABA during eDiary recording
- Lung function [ Time Frame: Through study completion, approximately 24 months ]Percentage predicted FEV1
- Allergic rhinitis symptoms [ Time Frame: Through study completion, approximately 24 months ]Rhinitis symptoms
- Allergic rhinitis medication use [ Time Frame: Through study completion, approximately 24 months ]Symptomatic medication use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654976
|Ostrowieckie Centrum Medyczne S.C.|
|Ostrowiec Świętokrzyski, Poland|
|Southampton General Hospital|
|Southampton, United Kingdom|
|Principal Investigator:||Graham Roberts, MD||University Hospital Southampton NHS Foundation|