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The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One day schedule | Active Comparator | Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day. |
|
| Rapid schedule | Active Comparator | Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allergovac polimerized (100/100) | Biological | Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse reactions as a measure of safety and tolerabitity | Across 12-15 weeks treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin changes from baseline | Subrogate efficacy | At baseline and 1 week after last administered dose |
| Skin reactivity changes from baseline | Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared. |
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Inclusion Criteria:
Patients must sign the Informed Consent Form.
Patients must be between 18 and 60 years of age.
Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
Patients will preferably be polysensitized to Phleum pratense. Polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by:
Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María C Gómez, Dr. | Roxall Medicina España S.A | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Zafra | Zafra | Badajoz | 06300 | Spain | ||
| Hospital de Henares |
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|
| At baseline and 1 week after last administered dose |
| Henares |
| Madrid |
| Spain |
| Hospital Clínico Granada | Granada | 18012 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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