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The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml. |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depigoid Parietaria judaica 1000DPP/ml | Biological | Subcutaneous monthly treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms score | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization | 2 years |
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Inclusion Criteria:
Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica >0,7KU/L
- Patients who are able to comply with the dose regime
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angel Ferrer, Dr | Hospital Vega Baja | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Viladecans |
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| Placebo | Biological | Subcutaneous monthly treatment |
|
| Barcelona |
| Barcelona |
| 08840 |
| Spain |
| Hospital Vega Baja | Alicante | Orihuela | 03314 | Spain |
| H. de sagunto | Sagunto | Sagunto | 46520 | Spain |
| Hospital General de Onteniente | Ontinyent | Valencia | Spain |
| Hospital Luis Alcañiz | Xàtiva | Valencia | Spain |
| Hospital Marina Baixa | Alicante | Spain |
| Hospital de Castellón | Castellon | Spain |
| Hospital Reina Sofía | Murcia | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital La Fe | Valencia | Spain |