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 | Completed Phase 2 DMC

• 1 other identifier: 1301-PG-PSC-203
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Subjects (%) suffering from immediate or delayed systemic grade 2 reactions

  Subjects (%) suffering from immediate or delayed systemic grade 2 reactions, according to EACCI 2006 classification, along the study

  Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.

Study Arms (2)

DP/MG/14-1

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

Biological: DP/MG/14-1

DP/MG/14-2

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

Biological: DP/MG/14-2

Interventions

DP/MG/14-1 BIOLOGICAL

The administration regimen will consist of a rush build-up régimen and a follow up period

DP/MG/14-1

DP/MG/14-2 BIOLOGICAL

The administration regimen will consist of a rush build-up régimen and a follow up period

DP/MG/14-2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
• If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
• If a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.

You may not qualify if:

• 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).
• Acute or chronic infectious conjunctivitis.
• Has acute or chronic inflammatory or infectious airways disease.
• Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
• History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
• Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
• Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (3)

Hospital de Conxo

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hosp Ntra Sra de la Candelaria

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital Lucus-Augusti

Lugo, 27003, Spain

Location

MeSH Terms

Conditions

Rhinitis; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jaime Sanchez

  Laboratorios Leti, S.L.U

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

ES (3)