E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The objective of the study is to know the biologic activity of the Latex reference extract (IHRP) in HEP units. The HEP value will be the reference of every other diagnostic or treatment preparations. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Open, unblinded and non-randomized biological assay. In each patient four ten- fold concentrations of allergen should be tested in duplicate starting with the lowest concentration with histamine as reference solution. Should the patient develop a skin reaction > 2 fold histamine reaction during test procedure a higher concentrated test solution will not be applied |
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E.2.2 | Secondary objectives of the trial |
No secondary endpoints will be measured |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
·Patients should live in an environment where allergy caused by Latex is a relevant problem. ·Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfill the inclusion criteria. ·A positive case history with inhalant allergy related to exposure to the allergen to be tested. ·A positive prick test (mean wheal diameter ³ 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE. ·A mean wheal diameter ³ 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
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E.4 | Principal exclusion criteria |
·Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested. ·Use of drugs that may interfere with the skin reactions. ·Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
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E.5 End points |
E.5.1 | Primary end point(s) |
Wheal size area (mm2) of the immediate phase reaction |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |