House Dust Mite Allergy
Conditions
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.
Interventions
BIOLOGICALAIT Tablet
1 tablet per day in 12 months
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed