Clinical trial NCT01433523: House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma
Official title: Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: HDM
AIT
asthma
asthma exacerbation
House dust mite induced asthma
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Ergomed
name: ACM Pivotal Global Central Laboratory
First posted: 2011-09-14
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.


Eligibility criteria: Key Inclusion Criteria:

* A clinical relevant history consistent with house dust mite induced asthma of at least 1 year prior to trial entry.
* Use of an appropriate amount of inhaled corticosteroid for the control of asthma symptoms.
* Documented reversible airway obstruction.
* Suitable level of asthma control.
* FEV1 ≥ 70% of predicted value.
* Positive Skin Prick Test response to Der pte and/or Der far.
* Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).

Key Exclusion Criteria:

* A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites).
* A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period from October to March.
* Any clinically relevant chronic disease.

Primary outcomes:
measure: Time to first moderate or severe asthma exacerbation after ICS reduction
timeFrame: Measured during the last 6 months of the trial
Secondary outcomes:
measure: Difference in changes in immunological parameters (IgE, IgG4)
timeFrame: Measured at the end of the trial
measure: Time to first severe asthma exacerbation after ICS reduction
timeFrame: Measured during the last 6 months of the trial
measure: Frequency of asthma exacerbations following ICS reduction
timeFrame: Measured during the last 6 months of the trial
measure: The average overall symptom score.
timeFrame: Measured during the last 6 months of the trial
measure: Symptom free days
timeFrame: Measured during the last 6 months of the trial
measure: Number and percentage of subjects with treatment emergent AEs
timeFrame: At end of trial
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
Study officials:
affiliation: Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
name: Christian Virchow, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.