Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

Miguel Blanca Gomez36 enrolled

Overview

To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo. The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Local Allergic Rhinitis

Interventions

Pangramin Plus D. pteronyssinusBIOLOGICAL

Subcutaneous immunotherapy with Dermatophagoides pteronyssinus

PlaceboBIOLOGICAL

Placebo for subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Prior to study specific examinations the patient has to give his/her written informed consent. * Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP). * Age: 18-55. * Negative skin prick-test to DP * Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP\>0.35 kU/L * If applicable negative urine pregnancy test and willingness to use effective form of contraception for the duration of involvement in the study. Exclusion Criteria: * Severe immunopathological or immunodeficiencies diseases. * Treatment with beta-blockers, even when administered topically * Severe psychological disorders * Severe Atopic Dermatitis * FEV1 \<70% predicted after appropriate pharmacological treatment * History of hypersensitivity or intolerance to excipients and / or trial medication or other medication to be used for protocol * Inability to adequately perform diagnostic tests or treatment * Awareness of other inhaled allergens (perennial or seasonal) clinically relevant to the subject and that may interfere with the response evaluation * Treatment with immunotherapy in the 5 years prior to his inclusion in the study

Locations (1)

Hospital Carlos Haya

Málaga, Malaga, Spain

Outcomes

Primary Outcomes

Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months

Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).

Time frame: Baseline, month 1,3,6,12,18, and 24

Secondary Outcomes

Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months

Time frame: Baseline, month 1,3,6,12,18, and 24

Change from Baseline response to intradermal test at 1,3,6,12 and 24 months

Time frame: Baseline, month 1,3,6,12,18, and 24

Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months

Time frame: Baseline, month 1,3,6,12,18, and 24

Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months

Time frame: Baseline, month 1,3,6,12,18 and 24

Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months

Time frame: Baseline, month 1,3,6,12,18 and 24

Adverse event

Time frame: 2 years

Data from ClinicalTrials.gov

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