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

Primary Purpose

Rhinitis, Rhinoconjunctivitis, Asthma

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

DP/MG/14-1

DP/MG/14-2

About this trial

This is an interventional treatment trial for Rhinitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hospital de Conxo
Hosp Ntra Sra de la Candelaria
Hospital Lucus-Augusti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

DP/MG/14-1

DP/MG/14-2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02340130

First Posted

January 13, 2015

Last Updated

August 7, 2018

Sponsor

Laboratorios Leti, S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02340130

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Leti, S.L.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Rhinoconjunctivitis, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DP/MG/14-1

Arm Type

Experimental

Arm Description

Arm Title

DP/MG/14-2

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

DP/MG/14-1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

DP/MG/14-2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaime Sanchez

Organizational Affiliation

Laboratorios Leti, S.L.U

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital de Conxo

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hosp Ntra Sra de la Candelaria

City

Santa Cruz de Tenerife

State/Province

Tenerife

ZIP/Postal Code

38010

Country

Spain

Facility Name

Hospital Lucus-Augusti

City

Lugo

ZIP/Postal Code

27003

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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