A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
NCT ID: NCT01454544
Last Updated: 2017-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
992 participants
INTERVENTIONAL
2011-10-31
2013-04-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALK house dust mite tablet 6 DU
AIT Tablet
1 tablet per day in 12 months
ALK house dust mite tablet 12 DU
AIT Tablet
1 tablet per day in 12 months
Placebo
AIT Tablet
1 tablet per day in 12 months
Interventions
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AIT Tablet
1 tablet per day in 12 months
Eligibility Criteria
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Inclusion Criteria
* Use of symptomatice medication for treatment of house dust mite allergy
* Positive skin prick test to mites
* Positive specific IgE
Exclusion Criteria
* Overlapping symptomatice allergies
* Previous treatment with immunotherapy
18 Years
65 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Locations
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Department of Respiratory Diseases, Lapeyronie Hospital
Montpellier, Montpellier, France
Countries
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References
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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.
Related Links
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SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitis
Other Identifiers
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2011-002277-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MT-06
Identifier Type: -
Identifier Source: org_study_id
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