Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense 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 in an up-dosing cluster regimen for 4 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depigoid Phleum pratense 1000DPP/Ml | Experimental | Depigmented and Polymerized Allergen extract of Phleum Pratense.Subcutaneous Immunotherapy in an up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. |
|
| 2 | Placebo Comparator | Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergen extract (Phleum pratense) | Biological | Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and medication score recorded by subjects | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal provocation test, Dose-response skin prick test, Rhinoconjunctivitis Quality of life questionnaire, visual scales, asthma symptom scores, medication scores, adverse event and severity adverse event, unplanned health care resource utilization | 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Sanchez | Hospital Río Carrión | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített | Budapest | Budapest | 1122 | Hungary | ||
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Subcutaneous monthly treatment |
|
| AEK Jarobetegszakrendelo Intézet Pulmonologia |
| Budapest |
| Budapest |
| 1134 |
| Hungary |
| Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet | Komárom | Komárom | 2900 | Hungary |
| Karolina Kórhaz Rendelöintézet Tüdögondozó | Mosonmagyaróvár | Mosonmagyaróvár | 9200 | Hungary |
| Hospital Universitario de Getafe | Madrid | Madrid | 28905 | Spain |
| H. Río Carrión | Palencia | Palencia | 34005 | Spain |
| Hospital Ntra. Sra de Sonsoles | Ávila | Spain |
| Hospital de Llerena | Badajoz | Spain |
| Hospital Militar de Burgos | Burgos | Spain |
| Hospital de Coria | Cáceres | Spain |
| Hospital Ntra. Sra. de la Montaña | Cáceres | Spain |
| Hospital Ciudad Real | Ciudad Real | Spain |
| Hospital San Juan de Dios | León | Spain |
| Hospital Virgen Blanca | León | Spain |
| Hospital San Millan | Logroño | Spain |
| Hospital de Merida | Mérida | Spain |
| Clinica Universitaria de Navarra | Navarra | Spain |
| Hospital del Bierzo | Ponferrada | Spain |
| Hospital Santa Barbara | Puertollano | Spain |
| Hospital de Santa Barbara | Soria | Spain |
| Hospital Universitario del Río Hortega | Valladolid | Spain |
| Hospital Clinico Lozano Blesa | Zaragoza | Spain |
| Hospital la Maz | Zaragoza | Spain |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000485 | Allergens |
| ID | Term |
|---|---|
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided