E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Eczema: a chronic inflammatory pruritic skin disease that follows a relapsing course and is often associated with elevated serum immunoglobulin E (IgE) levels and a personal or family history of allergies, allergic rhinitis and asthma. It is thought that atopic eczema results from an overactivity of T helper 2 (Th2) lymphocytes and down-regulation of T helper 1 (Th1) activity. |
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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 |
To investigate the effect of AeroDerm on Eczema Area and Severity Index (EASI) score in subjects with Atopic Eczema.
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E.2.2 | Secondary objectives of the trial |
To examine the effects of AeroDerm on Investigator Global Assessment (IGA), time to remission, incidence of skin infections, use of topical corticosteroids, levels of T cell subsets/ IgE.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Adult males and females > 18 years. •Subjects who currently have allergic eczema with an EASI score in the range of 10-35. Subjects with an EASI score in the range of 36-50 may be included at the discretion of the Investigator. •Subjects who have been on a stable dose of topical medications for eczema for ≥ 1 month from screening but whose eczema is not adequately responsive to, or controlled by, conventional topical treatments (eg: topical steroids, Tracrolimus, Pimecrolimus). •Subjects who have not had systemic immunosuppressive therapy (eg systemic steroids) within 1 month of screening. •Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception. •Subjects who have a pre-study medical history, physical examination and vital signs acceptable to the investigator. •Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator. •Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening. •Subjects who are negative for drugs of abuse tests at screening and admission. •Subjects with stable, adequately treated medical conditions other than eczema may be enrolled provided the Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments for medical conditions (other than eczema). •Subjects who are able and willing to give written informed consent.
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E.4 | Principal exclusion criteria |
•Subjects who do not conform to the above inclusion criteria. •Subjects who have the following medical conditions: Diabetes mellitus, Thyroiditis, Rheumatiod arthritis, Multiple sclerosis, Uveitis, Sarcoidosis, Glomerulonephritis, Helminthic infection. •Subjects who have a history of relevant drug hypersensitivity. •Subjects who have a history of alcoholism. •Subjects who have a history of drug abuse. •Subjects who have a significant infection at the time of screening and/or admission. •Subjects who are having acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn), may be asked to reschedule their screening and/or admission to when they are not longer having acute symptoms. •Subjects who have an acute infection such as influenza at the time of screening and/or admission. •Female subjects who are not using an acceptable method of contraception. •Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing. •Subjects who have previously received AeroDerm. •Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study. •Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis). •Subjects who cannot communicate reliably with the investigator. •Subjects who are unlikely to co-operate with the requirements of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The effect of AeroDerm on Eczema Area and Severity Index (EASI) score.
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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Last subject last follow up visit (provided in the protocol) |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |