NCT01454544

A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 992 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• House Dust Mite Allergy

Interventions

Type	Name	Description
BIOLOGICAL	AIT Tablet	1 tablet per day in 12 months

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-10-19
• Last updated: 2017-01-30

Locations

1 site across 1 country: France