Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.

Official Title
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Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Biological: DEPIGOID phleum
* Biological: DEPIGOID Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Local allergic rhinitis with sensitization to grass pollen Skin prick test and serum specific IgE negative to grass pollen. Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen. Written informed consent Exclusion Criteria: Immunological diseases Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers. Treatment with beta-blockers Severe psychological disorders Severe atopic dermatitis FEV1 < 70% of reference value after treatment Hypersensitivity or intolerance to excipients and / or medication trial. Failure to adequately perform diagnostic tests or treatment. Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response. Immunotherapy in the 5 years prior to their inclusion in the study. Pregnant women or at risk of pregnancy and lactating women.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEPIGOID phleum<br>The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection. | Biological: DEPIGOID phleum<br>* Subcutaneous Immunotherapy with modified extract of Phleum pollen.<br>|
| Placebo Comparator: DEPIGOID Placebo & DEPIGOID Phleum<br>This arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study. DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract. | Biological: DEPIGOID phleum<br>* Subcutaneous Immunotherapy with modified extract of Phleum pollen.<br>Biological: DEPIGOID Placebo<br>* Placebo for subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and medication scores comparison between active and placebo group | Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. 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). | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to nasal allergen provocation test with phleum (NAPT-Phl) | The response to NAPT-Phl with increasing concentrations of phleum pratense (0.001-0.01-0.05-0.1 mcg/ml) will be evaluated by nasal symptoms and acoustic rhinometry. | two years | 
| Skin prick-test (SPT) with phleum. | Evaluation of SPT wheal size. | 2 years | 
| Intradermal test (IDT) with phleum | IDT wheal and erythema size. | 2 years | 
| FEV1 |  | 2 years | 
| Quality of life questionnaire RQLQ |  | 2 years | 
| Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage |  | 2 years | 
| Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage. |  | 2 years | 
| Heart rate |  | 2 years | 
| Blood pressure |  | 2 years | 
| Adverse events |  | 2 years |