Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||5 Years - 17 Years|
- - Written informed consent - Male or female of any race/ethnicity aged 5-17 years - A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods - A clinical history of HDM allergic asthma - Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms - A clinical history of asthma exacerbations in the past two years - One or more of the following within the past 4 weeks prior to randomisation: - Daytime asthma symptoms more than twice/week - Any nocturnal awakening due to asthma - SABA rescue medication needed for treatment of asthma symptoms - Any activity limitation due to asthma - Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements - Clinical history of HDM AR within the last year prior to randomisation - An average TCRS>0 during the baseline period - Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D.
- - Positive SPT to D.
- - Subject willing and able to comply with trial protocol
Exclusion Criteria:- Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or other perennial allergen - Has experienced a life-threatening asthma attack - Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids - Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids - Any SLIT or SCIT treatment with D.
- - Ongoing treatment with any allergy immunotherapy product - Any clinically relevant condition or chronic disease incl.
- - Has a diagnosis of eosinophilic oesophagitis - A relevant history of systemic allergic reactions - Ongoing treatment with OCS - Treatment with restricted and prohibited concomitant medication - Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening - A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Hungary, Poland, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite|
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.
Experimental: Active treatment
Subject's ICS or ICS/LABA background medication plus HDM SLIT-tablet
Placebo Comparator: Placebo
Subject's ICS or ICS/LABA background medication plus placebo oral tablet
Biological: - HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Other: - Placebo
Placebo sublingual tablet, for daily administration (1 tablet per day)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.