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

NCT01454544 — Phase 3, Completed, 992 participants, ALK-Abelló A/S

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Registry	NCT01454544, acronym MT-06
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	992 (Actual)
Sponsor	ALK-Abelló A/S (Industry)
Conditions	House Dust Mite Allergy
Interventions	AIT Tablet (Biological)
Dates	start 2011-10-01, primary completion 2013-04-01, completion 2013-04-01, first posted 2011-10-19, last updated 2017-01-30
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions
ALK house dust mite tablet 6 DU	Experimental	Biological: AIT Tablet
ALK house dust mite tablet 12 DU	Experimental	Biological: AIT Tablet
Placebo	Placebo comparator	Biological: AIT Tablet

AIT Tablet (Biological): 1 tablet per day in 12 months

+Outcome measures

Primary outcomes

Evaluation of allergy symptoms and use of symptomatic medication [1 year with treatment]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Department of Respiratory Diseases, Lapeyronie Hospital	Montpellier, Montpellier	France

+Publications

Results publication: Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12. PMID 29656145

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