Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
Interventions
BIOLOGICALDEPIGOID phleum
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
BIOLOGICALDEPIGOID Placebo
Placebo for subcutaneous administration
Sponsors
Laboratorios Leti, S.L.
Plaza del Hospital Civil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and medication scores comparison between active and placebo group | two years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin prick-test (SPT) with phleum. | 2 years | Evaluation of SPT wheal size. |
| Intradermal test (IDT) with phleum | 2 years | IDT wheal and erythema size. |
| FEV1 | 2 years | — |
| Quality of life questionnaire RQLQ | 2 years | — |
| Response to nasal allergen provocation test with phleum (NAPT-Phl) | two years | 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. |
| 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 | — |
| 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 | — |
Countries
Spain
Outcome results
None listed