Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract - Full Text View

Sponsored by:	Laboratorios Leti, S.L.
Information provided by:	Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:	NCT00622362

Purpose

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite

Condition	Intervention	Phase
Allergic Asthma	Biological: DEPIGOID Dermatophagoides pteronyssinus Biological: Polymerized TOL of Dermatophagoides pteronyssinus Biological: Placebo Comparator	Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites

Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:

Symptom and medication scores [ Time Frame: 1 year per patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources [ Time Frame: 1 year per patient ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Dose response prick-test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Inflammatory markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Use of health resources [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Subcutaneous administration	Biological: DEPIGOID Dermatophagoides pteronyssinus Subcutaneous administration:0.5 ml/month during 1 year
B: Experimental Sublingual administration	Biological: Polymerized TOL of Dermatophagoides pteronyssinus Sublingual immunotherapy. Two drops daily during 1 year
C: Placebo Comparator Sublingual administration	Biological: Placebo Comparator Sublingual immunotherapy. Two drops daily during 1 year

Detailed Description:

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).

Eligibility

Ages Eligible for Study:	5 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent signed by the patient and guardian.
Positive clinical history of allergy to dust mites.
FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
Age-between 5 and 14 years.
Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size > 3 mm diameter and / or RAST (> 0.7 kU / L).

Exclusion Criteria:

Patients out of the age range.
Use of immunotherapy during the last four years.
Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..).
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- Patients suffering from immune deficiencies
- Patients with serious psychiatric / psychological disturbances
Patients aspirin intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622362

Contacts

Contact: María José Gómez, BcS

+34 917711790

mjgomez@leti.com

Locations

Spain
Hospital Universitario La Fé	Recruiting
Valencia, Spain, 46009
Contact: Antonio Nieto, MD PhD +34 961973258 nieto_ant@gva.es
Principal Investigator: Antonio Nieto, Dr. PhD.

Sponsors and Collaborators

Laboratorios Leti, S.L.

Investigators

Principal Investigator:

Antonio Nieto, MD PhD

Unaffiliated

More Information

Responsible Party:	Laboratorios LETI S.L. Unipersonal ( María José Gómez. )
Study ID Numbers:	2006-000571-15, 101-PG-COM-143
Study First Received:	January 10, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00622362
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Leti, S.L.:

Immunotherapy
Allergy
Allergoid
Depigmented

Polymerized
Allergen-extract
mites
Asthma

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009