E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019857 |
E.1.2 | Term | Hereditary allergy |
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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 |
The primary objective for this research project is to provide evidence that by administering a common allergen such as house dust mite to children before they develop any sensitisation, we can induce tolerance to that allergen. This will prevent the immune system developing an allergic response and general sensitisation that ultimately leads to asthma and allergy development. The goal is to test the hypothesis that by intervening early in life we can alter the immune response and prevent asthma and allergy development. |
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E.2.2 | Secondary objectives of the trial |
During the course of the study we will be collecting blood samples at 6 and 18 months. These samples will allow us to evaluate how the immune system responds to administeration of allergen, by analysing differences in active and placebo groups, in different types of immune cells, and chemicals that are released by these cells. Even if the intervention does not work, this analysis will still help us to determine why it did not work, what changes were introduced and what was lacking and how this can be improved for future trials. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: Infants aged 5 to 9 months at high risk of development of asthma and atopy, as defined by two or more first degree relatives (i.e. biological mother, father or sibling) affected by asthma or allergy, assessed through standardised questionnaires. |
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E.4 | Principal exclusion criteria |
Infants with positive skin test to one or more of 6 common allergens (house dust mite, grass pollen, cat, cows’ milk, egg white and peanut), prior to randomization at the age of 6-9 months, will be excluded. Following initial agreement and consent of the parents, skin prick test will be performed (in duplicate for house dust mite), on the volar surface of the forearm of the infant, using standardised methodology. A mean wheal diameter of ≥3mm when compared with saline control will be regarded as positive, the infant will be considered sensitized and excluded from the study. Infants with major concurrent health problems (e.g. congenital heart disease, cystic fibrosis, those requiring special feeding regimens on account of prematurity or illness) will be also be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure for this study is the cumulative prevalence of sensitisation to house dust mite over the 12 months intervention period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
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 | 2 |
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 | Yes |
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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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |