MedTrace Logo

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

NCT02340130 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-08-08

No results posted yet for this study

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.

Conditions

  • Rhinitis
  • Rhinoconjunctivitis
  • Asthma

Interventions

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

Sponsors & Collaborators

  • Laboratorios Leti, S.L.

    lead INDUSTRY

Principal Investigators

  • Jaime Sanchez · Laboratorios Leti, S.L.U

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • Spain

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 NCT02340130 on ClinicalTrials.gov