E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The development of contact allergy to aluminium during hyposensitization therapy. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objectives; •To estimate the proportions of children and adults who develop contact allergy to aluminium during the hyposensitization therapy.
•To compare the proportions of children and adults with a positive patch test to aluminium between groups, those with late local reactions, characterized as an by itching subcutaneous nodules and those without manifestations symptoms in three parallel groups.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives; •To investigate the frequency of contact allergy in atopic children and adults with allergic rhinitis and/or asthma •To compare the contact allergy rates between atopic children and adults with and without atopic dermatitis •To make comparison between groups considering the following possible risk factors for developing persisting itching nodules with contact allergy to aluminium. - Number of received doses/injections of hyposensitization extracts - Sex - Age - Other medication ( e.g. antacids) - Use of deodorants, antiperspirants - Work or hobby which involves exposure to aluminium
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed written consent given by adult participants, children more than 15 years of age and parent/guardian. Children and adults who will start there hyposensitisation therapy during 2007 and 2008 at 22 hospital clinics in Sweden.
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E.4 | Principal exclusion criteria |
Experienced anaphylaxis during skin tests. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A positive patch test to aluminium Development of an itching nodule and the proportion of individuals that develop itching nodules in the group with a positive patch test to aluminium in comparison with those who develop an itching nodule with a negative patch test to aluminium.
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
To exclude that a general change in aluminium exposure in the population,control group incl. after1y |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 22 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |