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The primary objective is to assess the concentration of each allergen extract (Phleum pratense and Dactylis glomerata) that induces a wheal size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution. The standardization procedure is carried out according to the Aas Method as specified in the guideline developed by the Nordic Council on Medicines
The trial will consist of a single visit, in which the following procedures will be carried out:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phleum pratense extract + Dactylis glomerata extract + positive control + negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the three concentrations of both allergenic extracts, along with the positive (histamine) and negative (saline solution) controls, will be applied to each subject. Phleum pratense: 100, 10 and 1 µg/mL Dactylis glomerata: 100, 10 and 1 µg/mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergenic extracts | Other | In each subject, a drop of each of the 3 concentrations of the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin induced wheal measurement | Measure of the area (mm^2) of the induced wheal on the skin upon applying each of the 3 concentrations of each allergenic extract (Phleum pratense and Dactylis glomerata), as well as those induced by positive (histamine) and negative controls, through the prick test. | 15 minutes after allergen introduction |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events registration | Registration of any adverse events that occurred during the course of the trial | Through study completion, an average of 6 months |
| Adverse reactions registration | Registration and documentation of any adverse reaction that occurred during the course of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Ojeda | ClÃnica de Asma y Alergia Dres. Ojeda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica de Asma y Alergia Dres. Ojeda | Madrid | 28006 | Spain |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.
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| Through study completion, an average of 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |