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Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis

NCT01603056 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2016-04-29

Study results available
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Summary

Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or without asthma.

Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy.

This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix.

Conditions

  • Allergic Rhinitis

Interventions

BIOLOGICAL

Pangramin SLIT HDM mix.

Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

BIOLOGICAL

Placebo

Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Zhang Luo, Professor · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT01603056 on ClinicalTrials.gov