To find out if people with allergic asthma caused by house dust mites will benefit from allergy vaccine given as a tablet.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018621-19-DE

Enrollment

800

Registered

2010-05-04

Start date

2011-09-30

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

House dust mite induced allergic asthma MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: ALK house dust mite (HDM) allergy immunotherapy tablet (AIT) Product Code: ALK HDM AIT Pharmaceutical Form: Oral lyophilisate INN or Proposed INN: N/A CAS Number: N/A Current Sponsor cod

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 an appropriate amount of inhaled corticosteroid (incl. combination products) in accordance with the GINA Guideline step 2-4 for the control of the 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 400-1200 mcg. • Documented reversible airway obstruction. • Asthma control level above or equal to 1.0 (asthma control questionnaire (ACQ) = 1.0) at screening. • Asthma control level between 1.0 and 1.5 (1.0 = ACQ = 1.5) at visit 3 (randomisation). • FEV1 = 70% of predicted value. • A clinical history consistent with mild to severe HDM-induced allergic rhinitis for at least 1 year. • Positive SPT response to Der pte and/or Der far. The negative control should be truly negative. A positive SPT response to Der pte and/or Der far is defined as wheal diameter = 3 mm. • 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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 and/or rhinitis if the seasonal allergen that may cause symptoms in 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of the ALK house dust mite (HDM) allergy immunotherapy tablet (AIT) (6 Development Unit (DU) and 12 DU) given once daily compared to placebo in subjects with HDM induced asthma, as measured by time to first asthma exacerbation after inhaled corticosteroid (ICS) reduction.;Secondary Objective: To determine the effects of ALK HDM AIT on asthma symptoms and immunology. To evaluate the effects of ALK HDM AIT on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics. ;Primary end point(s): The primary endpoint is the time to first asthma exacerbation during period 3 (ICS reduction). Time to first asthma exacerbation is measured in days from start of period 3 (ICS reduction). The definition of asthma exacerbation used is that the subject must experience one or more of the criteria listed below. The definition of asthma exacerbation used in this trial is based on the recommendations given in the joint statement from the American Thoracic Society and the European Respiratory Society 2009. The clinical interpretation presented below is based on recommendations from GINA, the joint statement from the American Thoracic Society and the European Respiratory Society 2009 as well as publications covering asthma exacerbations. The cut-off for daytime symptoms is based on recommendations from a multinational board of clinical experts within asthma treatment. In order to fulfil the criteria for a moderate asthma exacerbation in practice, the subject must experience one or more of the following criteria leading to a change in treatment: a) Nocturnal awakening(s) due to asthma requiring SABA use for at least 2 consecutive nights or an increase of minimum 0.75 in daily symptom score from baseline value on at least 2 consecutive days. b) An increase from baseline value in occasions of SABA use on at least 2 consecutive days (a minimum increase of 4 puffs per day). c) = 20% decrease in PEF fr	—

Measure

Time frame

Main Objective: To evaluate the efficacy of the ALK house dust mite (HDM) allergy immunotherapy tablet (AIT) (6 Development Unit (DU) and 12 DU) given once daily compared to placebo in subjects with HDM induced asthma, as measured by time to first asthma exacerbation after inhaled corticosteroid (ICS) reduction.;Secondary Objective: To determine the effects of ALK HDM AIT on asthma symptoms and immunology. To evaluate the effects of ALK HDM AIT on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics. ;Primary end point(s): The primary endpoint is the time to first asthma exacerbation during period 3 (ICS reduction). Time to first asthma exacerbation is measured in days from start of period 3 (ICS reduction). The definition of asthma exacerbation used is that the subject must experience one or more of the criteria listed below. The definition of asthma exacerbation used in this trial is based on the recommendations given in the joint statement from the American Thoracic Society and the European Respiratory Society 2009. The clinical interpretation presented below is based on recommendations from GINA, the joint statement from the American Thoracic Society and the European Respiratory Society 2009 as well as publications covering asthma exacerbations. The cut-off for daytime symptoms is based on recommendations from a multinational board of clinical experts within asthma treatment. In order to fulfil the criteria for a moderate asthma exacerbation in practice, the subject must experience one or more of the following criteria leading to a change in treatment: a) Nocturnal awakening(s) due to asthma requiring SABA use for at least 2 consecutive nights or an increase of minimum 0.75 in daily symptom score from baseline value on at least 2 consecutive days. b) An increase from baseline value in occasions of SABA use on at least 2 consecutive days (a minimum increase of 4 puffs per day). c) = 20% decrease in PEF fr

—

Secondary

Measure	Time frame
Secondary end point(s): Key Secondary Endpoints Key secondary endpoints are: • Time to first deterioration in asthma symptoms. Time in days from start of period 3 (ICS reduction) to the first asthma exacerbation fulfilling criterion a), see section 8.6.1 of the protocol. • Immunology measured at end of trial in terms of specific IgE-blocking factor against HDM allergens. Other Secondary Endpoints • Severe asthma exacerbation. - Time to first severe asthma exacerbation. Time in days from start of period 3 to the first severe asthma exacerbation fulfilling criterion e) or f), see section 8.6.1 of the protocol. • Asthma exacerbations during period 3. - The frequency of asthma exacerbations (number/percentage of subjects) during period 3. • Asthma symptoms. - The average overall symptom score over the first asthma exacerbation free period during the first 3 months of period 3. - The average overall symptom score over the first asthma exacerbation free period during entire period 3. - Symptom free days during period 3. A symptom free day is defined as a day with: o No asthma symptoms (symptom score =0). o No need for SABA. o No increase in ICS or use of oral steroid. • Symptomatic medication. - Time to first increased use of SABA. Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion b), see section 8.6.1 of the protocol. • Lung function. - The average morning PEF and diurnal variability over the first asthma exacerbation free period during first 3 months of period 3. - The average morning PEF and diurnal variability over the first asthma exacerbation free period during entire period 3. - Time to first deterioration in lung function. Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion c), see section 8.6.1 of the protocol. - Change in FEV1 from baseline to visit 9 (ICS reduction). • Asthma control. - The overall ACQ for the last week of period 2 (treatment	—

Measure

Time frame

Secondary end point(s): Key Secondary Endpoints Key secondary endpoints are: • Time to first deterioration in asthma symptoms. Time in days from start of period 3 (ICS reduction) to the first asthma exacerbation fulfilling criterion a), see section 8.6.1 of the protocol. • Immunology measured at end of trial in terms of specific IgE-blocking factor against HDM allergens. Other Secondary Endpoints • Severe asthma exacerbation. - Time to first severe asthma exacerbation. Time in days from start of period 3 to the first severe asthma exacerbation fulfilling criterion e) or f), see section 8.6.1 of the protocol. • Asthma exacerbations during period 3. - The frequency of asthma exacerbations (number/percentage of subjects) during period 3. • Asthma symptoms. - The average overall symptom score over the first asthma exacerbation free period during the first 3 months of period 3. - The average overall symptom score over the first asthma exacerbation free period during entire period 3. - Symptom free days during period 3. A symptom free day is defined as a day with: o No asthma symptoms (symptom score =0). o No need for SABA. o No increase in ICS or use of oral steroid. • Symptomatic medication. - Time to first increased use of SABA. Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion b), see section 8.6.1 of the protocol. • Lung function. - The average morning PEF and diurnal variability over the first asthma exacerbation free period during first 3 months of period 3. - The average morning PEF and diurnal variability over the first asthma exacerbation free period during entire period 3. - Time to first deterioration in lung function. Time in days from start of period 3 to the first asthma exacerbation fulfilling criterion c), see section 8.6.1 of the protocol. - Change in FEV1 from baseline to visit 9 (ICS reduction). • Asthma control. - The overall ACQ for the last week of period 2 (treatment

—

Countries

Austria, Croatia, Denmark, France, Germany, Latvia, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain, United Kingdom

Contacts

Public ContactClinical Project Manager

ALK-Abelló A/S

bmt@alk-abello.com+454574 7995

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026