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| Name | Class |
|---|---|
| Laboratorios Leti, S.L. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEPIGOID phleum | Active Comparator | The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection. |
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| DEPIGOID Placebo & DEPIGOID Phleum | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEPIGOID phleum | Biological | Subcutaneous Immunotherapy with modified extract of Phleum pollen. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Blanca, MD, PhD | Hospital Regional Universitario, Málaga, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infanta Leonor | Madrid | Madrid | Spain | |||
| Hospital Regional Universitario Carlos Haya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29168570 | Derived | Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| DEPIGOID Placebo | Biological | Placebo for subcutaneous administration |
|
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 |
| Málaga |
| Malaga |
| Spain |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |