NCT02340130

Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma

A Multicentre, Open Label, Phase IIb Clinical Trial to Evaluate Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites Mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides Pteronyssinus / Lepidoglyphus Destructor and DP/MG/14-2 Dermatophagoides Pteronyssinus /Blomia Tropicalis) in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.

Detailed description

The objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.

Conditions

• Rhinitis
• Rhinoconjunctivitis
• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	DP/MG/14-1	The administration regimen will consist of a rush build-up régimen and a follow up period
BIOLOGICAL	DP/MG/14-2	The administration regimen will consist of a rush build-up régimen and a follow up period

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2015-01-16
• Last updated: 2018-08-08

Locations

3 sites across 1 country: Spain