A clinical trial involving research of the house dust mite SLIT-tablet
Research type
Research Study
Full 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
IRAS ID
232819
Contact name
Manoj Satyavarapu
Contact email
Sponsor organisation
ALK-Abelló A/S
Eudract number
2016-004363-39
Clinicaltrials.gov Identifier
17691, IND number
Duration of Study in the UK
4 years, 3 months, 20 days
Research summary
Summary of Research
House Dust Mite (HDM) is an important inhalant allergen among children and adolescents found to be the most important risk factor for asthma development. Patients are treated with antihistamines or local corticosteroids depending on the severity and unfortunately none of the mentioned treatment options provide long-term, post-treatment benefits or alter the natural course of the allergic.
In this study ALK-Abelló A/S(study sponsor) is looking to investigate whether add-on treatment with the HDM SLIT tablet (sublingual immunotherapy- drug taken by placing under the tongue)(study drug)can provide a relevant treatment benefit in terms of a reduced number of asthma exacerbations for children and adolescent participants with HDM allergic asthma. In addition this trial will generate information on the Quality of Life (QoL) and Economic benefits of the study drug.In this trial, participants will be randomised (1:1) to treatment with the HDM SLIT-tablet (study drug) or placebo in addition to their usual asthma treatment for a treatment period of 2 years. Participants in the active treatment group may experience treatment benefits in terms of improved asthma symptom control and a reduced number of asthma exacerbations, as well as a reduced burden of symptoms related to HDM AR.
The HDM SLIT-tablet is approved in the United States, Europe, Japan, and Australia for treatment of HDM respiratory allergic disease in the adult population and in Europe and Japan for treatment of adolescents (12-17 years) with HDM Allergic rhinitis(inflammation in the nose) (AR).
About 600 participants will be enrolled on this study in up to 10 countries.
Summary of Results
What was the study called?
The title of the study was ʻA 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’.2. When and where did the study take place?
The study took place from February 2018 to August 2022. It started before the COVID-19 pandemic and ended during the pandemic. The participants were treated in 9 different countries: Poland, Spain, Bulgaria, Hungary, Germany, France, United Kingdom, USA and Russia.3. What was the study about?
Research has shown that the HDM SLIT-tablet can reduce the number of asthma attacks in adults. The overall aim of this study was to know if the HDM SLIT tablet could also reduce the number of asthma attacks in children and adolescents.4. Who took part in the study?
Children and adolescents 5-17 years old with asthma caused by allergy to house dust mites took part in the study. The participants had had 1 or more asthma attacks in the past few years before the study. The participants also had nose symptoms caused by their allergy to house dust mites.5. Which medicines were studied?
All participants used their usual daily asthma preventer medication. When they needed it, they also used their asthma reliever medication (SABA-inhaler). The participants were divided in 2 groups where they got either the HDM SLIT tablet or a pretend tablet called ‘placebo’. It was completely random which group each participant was in. It was not known until the study was over, which group the participants were in.The HDM SLIT-tablet contained an allergen extract from the house dust mites the participants were allergic to. When the tablet was placed under the tongue the allergens in the extract were taken up by the immune system of the body. The intention was to train the body to get used to the allergens. This should increase the body's ability to cope with HDM allergy.
The placebo-tablet did not contain any real medicine, but it looked, smelled and tasted exactly as the HDM SLIT-tablet.
6. What were the side effects?
A side effect is an unwanted medical event that the doctor believes is caused by the medicine in the study.Most participants in the study had at least one side effect (78% of participants in the HDM SLIT tablet group and 57% of participants in the placebo group). Most side effects were mild. This meant that the side effect did not interfere with the participant’s daily activities.
The most common side effects of the HDM SLIT-tablet were:
- Itching in the mouth (experienced by 61% of participants in the HDM SILT-tablet group and by 22% in the placebo group)
- Irritation in the throat (experienced by 57% of participants in the HDM SILT-tablet group and 31% in the placebo group)
- Itching in the ear (experienced by 36% of participants in the HDM SILT-tablet group and 19% in the placebo group)One child who got the HDM-SLIT tablet was hospitalised because of a side effect. The side effect was an allergic condition called ‘eosinophilic oesophagitis’. This is an allergic inflammation in the oesophagus. If the condition is not treated it can damage the tissue over time. It can happen when the immune system responds to something you are allergic to.
7. What were the results of the study?
During the study the participants had fewer asthma attacks than the researchers had expected. During the COVID-19 pandemic there were even fewer. The study could not show that the HDM SLIT-tablet reduced the number of asthma attacks.8. How did the COVID-19 pandemic impact the study?
The study was impacted by the COVID-19 pandemic as the number of asthma attacks fell during the COVID-19 pandemic. Besides impacting the study results, this made it difficult to find children and adolescents to join the study. During the COVID-19 pandemic people used facemasks and kept their distance from each other. This meant that there were fewer viral infections like the common cold and influenza. Researchers know that these viral infections cause asthma attacks. Fewer viral infections may be the reason why there were fewer asthma attacks during the COVID 19 pandemic.9. How has this study helped people and researchers?
The study showed that the HDM SLIT-tablet was well tolerated by the participating children and adolescents with asthma. It also showed that the HDM SLIT-tablet is suitable to take at home, after it has been taken the first time at the doctor’s clinic.10. Are there plans for further studies?
Another study is ongoing where researchers want to know if the HDM SLIT-tablet can reduce symptoms and use of rescue medication caused by allergy to house dust mites in children.11. Who sponsored the study?
ALK-Abelló sponsored the study.
The contact details are: ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm, Denmark, Phone: +45 4574 7576.12. Where can I find more information?
You can find the results from the study in the EudraCT database here: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSuN3Cw0CwvdYuvj4K0ilrA-2FkyAC-2BhESdhQDwLU16qtFyoAIM_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKq1402mDWKmoetr6oI7YIO5d2Oi55TUeDrn0L0TpUnHPZwwslPYYMqmcFgdraeugNmpvmJcHho9e-2FkOcVwrMNWat2yKUVNKcSxC4heQJAdQf0hpeb4-2FpDOYWnE0pt7OaCg4ShFHgUHUTDFMm7FOJeIdFM7-2FiVmRqB8FtoB4F484w-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C3a5d4769c1134c05dbbd08db41a7f9a0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638175961923028457%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=DrwCy85reBSlw7Z3JPLydkIFs5QpB95CxSC4w1f0uso%3D&reserved=013. Thank you
Thank you to all children and adolescents and their families who took part in the study.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
17/WM/0425
Date of REC Opinion
15 Jan 2018
REC opinion
Further Information Favourable Opinion