Completed

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

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What is being tested

DP/MG/14-1

+ DP/MG/14-2

Biological
Who is being recruted

Asthma+11

+ Bronchial Diseases

+ Hypersensitivity

From 18 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2014
See protocol details

Summary

Principal SponsorLaboratorios Leti, S.L.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT02340130
Principal SponsorLaboratorios Leti, S.L.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

57 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesInfectionsLung DiseasesLung Diseases, ObstructiveNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRespiratory Tract InfectionsRhinitis

Criteria

7 inclusion criteria required to participate
Subject has provided appropriately signed and dated written informed consent.
Men and women aged 18 years and 70 years of age at Visit 1.
Has an FEV1 value 80% of predicted normal value at Visit 1.
Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
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10 exclusion criteria prevent from participating
Any contraindication for treatment with allergen specific immunotherapy.
Subjects with a previous history of anaphylaxis.
Patients with hospital admission due to asthma exacerbations within 1 year prior to V1.
Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
DP/MG/14-1: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period

Group II

Experimental
DP/MG/14-2: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Hospital de Conxo

Santiago de Compostela, SpainOpen Hospital de Conxo in Google Maps
Suspended

Hosp Ntra Sra de la Candelaria

Santa Cruz de Tenerife, Spain
Suspended

Hospital Lucus-Augusti

Lugo, Spain
Completed3 Study Centers