Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. The MITRA Trial. - MITRA

Phase 1

• Conditions: House dust mite induced allergic asthma; MedDRA version: 12.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2010-018621-19-SK
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-26
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Written informed consent obtained before entering the trial.
Male or female = 18 years.
• A clinical relevant history consistent with HDM-induced asthma of at least 1 year prior to trial entry.
• Use of asthma medication (e.g. combination products) for the control of asthma symptoms for a period of at least 6 months within the past year.
• Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg.
• Documented reversible airway obstruction.
• Asthma control level above or equal to 1.0 (asthma control questionnaire (ACQ) = 1.0) at visit 1 (screening).
• Asthma control level between 1.0 and 1.5 (1.0 = ACQ = 1.5) at visit 3 (randomisation).
Electronic diary compliance rate between visit 2 and visit 3 = 80% at visit 3 (randomisation)
• FEV1 > 60% of predicted value.
• A clinical history consistent with HDM-induced allergic rhinitis for at least 1 year.
• Positive SPT response (wheal diameter = 3 mm larger than the negative control) to Der pte and/or Der far.
• Positive specific IgE against Der pte and/or Der far (= IgE Class 2; = 0.70 KU/L).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• A clinical history of persistent allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized (except HDM).
• A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period of the year corresponding the ICS reduction period (period 3)
• Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
• Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified