NCT01603056

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

A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced Rhinitis With or Without Asthma.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 5 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Extensive clinical experience has been gained due to the widespread use of Pangramin® SLIT and other SLIT products as named patient products, both with respect to the types and the frequencies of the adverse events(AEs) observed. No safety concerns have been found. The optimal therapeutic dose range regarding SLIT is not fully elucidated. The fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. The relationship between dose and effect is thus not fully elucidated. The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-05-22
• Last updated: 2016-04-29
• Results posted: 2016-04-29

Locations

1 site across 1 country: China