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| ID | Type | Description | Link |
|---|---|---|---|
| 6078-PG-OSL-145 | Other Identifier | Sponsor Protocol number |
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The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
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 three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Biological vaccine | Experimental | The first active arm will receive a dose that is 10x less than the dose of the other arm |
|
| B: biological vaccine | Experimental | The first active arm will receive a dose that is 10x more than the dose of the other arm |
|
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy with modified extract of P. pratense pollen | Biological | Sublingual (2 drops daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal provocation test | 1 year | |
| Dose-response skin prick-test | 1 year | |
| Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Félix Lorente, Prf. PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico de Salamanca | Salamanca | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D003233 | Conjunctivitis, Allergic |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Placebo | Other | Placebo 2 drops daily |
|
| 1 year |
| Medication scores | 1 year |
| Visual scales | 1 year |
| "In vitro" immunological tests | 1 year |
| Record of adverse events | 1 year |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |