A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
- Conditions
- House Dust Mite Allergy
- Interventions
- Biological: AIT Tablet
- Registration Number
- NCT01454544
- Lead Sponsor
- ALK-Abelló A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 992
- 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
- History of uncontrolled asthma
- Overlapping symptomatice allergies
- Previous treatment with immunotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALK house dust mite tablet 12 DU AIT Tablet - ALK house dust mite tablet 6 DU AIT Tablet - Placebo AIT Tablet -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Respiratory Diseases, Lapeyronie Hospital
🇫🇷Montpellier, France