drugset / Trial / NCT00389363
Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).
Timeline
- Start
- 2006-08
- Primary completion
- 2008-04
- Completion
- 2008-04
Outcome
Met primary endpoint
release “The MITRA trial met its primary clinical endpoint. Patients who received the dose of 12 SQ-HDM experienced a significant improvement in their asthma control” alk.net ↗
Publications
- 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.
- Mosbech H, Canonica GW, Backer V, de Blay F, Klimek L, Broge L, Ljorring C. SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms. Ann Allergy Asthma Immunol. 2015 Feb;114(2):134-40. doi: 10.1016/j.anai.2014.11.015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SQ-HDM | Other / unclassified | 1 unknown | Other |
| Subject | SQ-HDM | Other / unclassified | 3 unknown | Other |
| Subject | SQ-HDM | Other / unclassified | 6 unknown | Other |