ALK HDM AIT MT-04 The MITRA trial

• Research type

  Research Study

• Full title

  Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma.

• IRAS ID

  55659

• Contact name

  Stephen Reginald Durham

• Eudract number

  2010-018621-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  There is supporting evidence that house dust mite (HDM) exposure is the most common indoor allergen associated with asthma world wide. Immunotherapy has been shown to provide therapeutic benefits to subjects with HDM induced asthma. ALK is planning this trial in order to investigate if clinically relevant improvements in lung function and symptoms and less dependency on asthma controller medication for the patient can be obtained. The objective of the trial is to measure the reduced risk for an asthma exacerbation in subjects with HDM induced asthma. When modifying the immune system by giving the ALK HDM AIT daily, the hypothesis is that the future risk of asthma exacerbations is reduced or avoided, resulting in less stress for the patient. This is a randomised, parallel-group, double-blind, placebo-controlled, multi-national, multi-centre trial in Europe. The trial will be initiated when the major pollen seasons in Europe (e.g. grass) are over. Approximately 800 subjects will be randomised to 1 of 3 treatment groups (2 doses of ALK House Dust Mite Allergen Immunotherapy Tablet (6 Development Unit or 12 Development Unit) or placebo) and receive treatment for at least 8 months and up to 18 months. The primary objective in this trial is to evaluate the efficacy of once-daily administration of ALK House Dust Mite Allergen Immunotherapy Tablet (6 Development Unit and 12 Development Unit) compared to placebo, as measured by reducing the risk for an asthma exacerbation in subjects with House Dust Mite induced asthma. The definition of asthma exacerbation used in this trial is based on the recommendations given in the joint statement made by the American Thoracic Society and the European Respiratory Society 2009.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/51

• Date of REC Opinion

  27 Sep 2010

• REC opinion

  Further Information Favourable Opinion