A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
MT-06
2 other identifiers
interventional
992
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 30, 2017
January 1, 2017
1.5 years
October 13, 2011
January 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
ALK house dust mite tablet 6 DU
EXPERIMENTALALK house dust mite tablet 12 DU
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1 tablet per day in 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of uncontrolled asthma
- Overlapping symptomatice allergies
- Previous treatment with immunotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Study Sites (1)
Department of Respiratory Diseases, Lapeyronie Hospital
Montpellier, Montpellier, 34295, France
Related Publications (1)
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: 29656145DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 19, 2011
Study Start
October 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
January 30, 2017
Record last verified: 2017-01