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House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma

NCT01433523 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2017-01-30

No results posted yet for this study

Summary

The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.

Conditions

Interventions

DRUG

ALK HDM AIT Placebo

Oral lyophilisate, Placebo, to be administered sublingually once daily

DRUG

ALK HDM AIT 6 DU

Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.

DRUG

ALK HDM AIT 12 DU

Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

Sponsors & Collaborators

  • Ergomed

    collaborator INDUSTRY

  • ACM Pivotal Global Central Laboratory

    collaborator INDUSTRY

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Christian Virchow, Prof.Dr.med. · Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-04-30
Completion
2014-02-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01433523 on ClinicalTrials.gov