A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
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.
Inclusion Criteria:
Exclusion Criteria:
Huntington Beach, California 92647, United States
San Diego, California 92123, United States
Pensacola, Florida 32503, United States
Chapel Hill, North Carolina 27599, United States
Oklahoma City, Oklahoma 73131, United States
Razgrad, 7200, Bulgaria
Razgrad, 7200, Bulgaria
Rousse, 7002, Bulgaria
Sofia, 1407, Bulgaria
North York, Canada
Frankfurt, Germany
Wroclaw, 53-201, Poland
Saint Petersburg, 194291, Russia
Chernivtsi, 58023, Ukraine
Dnipro, 49006, Ukraine
Kryvyi Rih, 50082, Ukraine
Kyiv, 03057, Ukraine
Kyiv, 03680, Ukraine
Kyiv, 04050, Ukraine
Lviv, 79000, Ukraine