House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma

Asthma Clinical Trial

— MITRA  

Official title:

Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433523
• Other study ID #: MT-04
• Secondary ID: 2010-018621-19
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2011
• Last updated: January 27, 2017
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2017
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: February 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ALK HDM AIT Placebo
Oral lyophilisate, Placebo, to be administered sublingually once daily
• ALK HDM AIT 6 DU
Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
• ALK HDM AIT 12 DU
Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6	Rostock

Sponsors (3)

Lead Sponsor	Collaborator
ALK-Abelló A/S	ACM Pivotal Global Central Laboratory, Ergomed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first moderate or severe asthma exacerbation after ICS reduction		Measured during the last 6 months of the trial
Secondary	Difference in changes in immunological parameters (IgE, IgG4)		Measured at the end of the trial
Secondary	Time to first severe asthma exacerbation after ICS reduction		Measured during the last 6 months of the trial
Secondary	Frequency of asthma exacerbations following ICS reduction		Measured during the last 6 months of the trial
Secondary	The average overall symptom score.		Measured during the last 6 months of the trial
Secondary	Symptom free days		Measured during the last 6 months of the trial
Secondary	Number and percentage of subjects with treatment emergent AEs		At end of trial