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Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

NCT01930461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2015-12-18

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

Conditions

  • Asthma
  • House Dust Mite Allergy

Interventions

BIOLOGICAL

SLIT tablets of HDM allergen extracts, 3 different doses (A)

Two sublingual tablets daily for 13 months

BIOLOGICAL

SLIT tablets of HDM allergen extracts, 3 different doses (B)

Two sublingual tablets daily for 13 months

BIOLOGICAL

SLIT tablets of HDM allergen extracts, 3 different doses (C)

Two sublingual tablets daily for 13 months

BIOLOGICAL

Placebo matching the SLIT tablets of HDM allergen extracts

Two sublingual tablets daily for 13 months

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Pascal Demoly, MD · Montpellier, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • France
  • Germany
  • Poland

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 NCT01930461 on ClinicalTrials.gov