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

NCT01454544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 992

Last updated 2017-01-30

No results posted yet for this study

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

BIOLOGICAL

AIT Tablet

1 tablet per day in 12 months

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01454544 on ClinicalTrials.gov