E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asthma and more specifically virus-induced exacerbations in allergic asthma patients |
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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 | 10015575 |
E.1.2 | Term | Exacerbation of asthma |
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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 | 10001705 |
E.1.2 | Term | Allergic asthma |
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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 | 10049868 |
E.1.2 | Term | Asthma exacerbation prophylaxis |
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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 |
Virus-induced exacerbations represent the major clinical manifestation of asthma, but the underlying mechanisms are poorly understood. Since virus-induced asthma exacerbations are associated with reduced Th1- and enhanced Th2 cytokine production, we hypothesise that the Th2 cytokine IL-5 critically impairs the host response to viral airway infections in allergic asthma patients leading to an exaggerated inflammatory response. With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients. |
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E.2.2 | Secondary objectives of the trial |
In addition, we aim to clarify the role of IL-5 during viral airway infection by analysis of the specific cellular immune responses against viruses during experimental rhinovirus infection in mild to moderate allergic asthma patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 18 – 50 years Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma Non-smoking or stopped smoking more than 12 months ago and ≤ 5 pack years Clinically stable, no history of exacerbations within the last 6 weeks prior to the study Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study Baseline FEV1 at least 80% of predicted PC20histamine < 9.8 mg/ml Positive skin prick test to one or more of the 12 common aeroallergen extracts |
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E.4 | Principal exclusion criteria |
Moderate to severe asthma patients (according to the GINA guidelines) Patients who have had an exacerbation during the past 6 months, as indicated by a course of systemic steroids or antibiotics Presence of antibodies directed against rhinovirus type 16 (titer > 4) Smokers or ex-smokers (< 12 months or > 6 pack years) Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1 Patients who are in close contact with young children (< 2 years), either professional or family related Participation in any clinical investigational drug treatment protocol within the preceding 3 months |
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E.5 End points |
E.5.1 | Primary end point(s) |
Lungfunction, determined by the difference in pre-bronchodilator FEV1 between day 70 and 77 (1 day prior and 6 days after inoculation with RV16). |
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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 | Yes |
E.6.4 | Safety | No |
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
| 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 | 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
|
The conditions leading to premature termination of the study are described in the study protocol (page 30). |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |