A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet

House Dust Mite Allergy Clinical Trial

— MT-06  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454544
• Other study ID #: MT-06
• Secondary ID: 2011-002277-38
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2011
• Last updated: January 27, 2017
• Start date: October 2011
• Est. completion date: April 2013

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 primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• A history of house dust mite allergy

• Use of symptomatice medication for treatment of house dust mite allergy

• Positive skin prick test to mites

• Positive specific IgE

Exclusion Criteria:

• History of uncontrolled asthma

• Overlapping symptomatice allergies

• Previous treatment with immunotherapy

Related Conditions & MeSH terms

• House Dust Mite Allergy
• Hypersensitivity

Intervention

Biological:
• AIT Tablet
1 tablet per day in 12 months

Locations

Country	Name	City	State
France	Department of Respiratory Diseases, Lapeyronie Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of allergy symptoms and use of symptomatic medication	Comparing the daily recording of symptoms and use of symptomatic medication during the last period of the trial between the actively treated patients and the placebo treated.	1 year with treatment

External Links

•   SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitis