Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.

Conditions
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Local Allergic Rhinitis

Intervention / Treatment
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* Biological: Pangramin Plus D. pteronyssinus
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pangramin Plus D. pteronyssinus<br>Pangramin Plus D. pteronyssinus 100% for subcutaneous injection | Biological: Pangramin Plus D. pteronyssinus<br>* Subcutaneous immunotherapy with Dermatophagoides pteronyssinus<br>|
| Placebo Comparator: Placebo<br>Placebo for subcutaneous injection | Biological: Placebo<br>* Placebo for subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, month 1,3,6,12,18, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months |  | Baseline, month 1,3,6,12,18, and 24 | 
| Change from Baseline response to intradermal test at 1,3,6,12 and 24 months |  | Baseline, month 1,3,6,12,18, and 24 | 
| Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months |  | 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 |  | 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 |  | Baseline, month 1,3,6,12,18 and 24 | 
| Adverse event |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local allergic rhinitis, subcutaneous immunotherapy, house dust mite allergy, Dermatophagoides pteronyssinus allergy