A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
Information source: ALK-Abelló A/S
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: House Dust Mite Allergy
Intervention: AIT Tablet (Biological)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: ALK-Abelló A/S Overall contact:
Ea Dige, MD, Phone: +45 45 74 75 76
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.
Clinical Details
Study design: Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Evaluation of allergy symptoms and use of symptomatic medication
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Ea Dige, MD, Phone: +45 45 74 75 76 Additional Information
Last updated: October 17, 2011
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