E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic asthma |
E.1.2 | System Organ Class | 100000004855 |
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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 |
To study the influence of clopidogrel on the inflammation following inhaled allergen challenge in asthma to enable a better understanding of the underlying pathology of asthma, and to assess whether clopidogrel might become a useful treatment. |
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E.2.2 | Secondary objectives of the trial |
To identify potential markers reflective of the disease process in asthma that might be potentially usable as a biomarker that could aid in the diagnosis and management of disease. To measure speech and breathing patterns in asthma to see if these can aid diagnosis or monitoring of asthma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Confirmed diagnosis of asthma Only taking as required short acting beta agonists as treatment Baseline forced expiratory volume in one second (FEV1)>80% predicted Age 18-50 years For female patients: menopausal >2yr or with childbearing potential but taking efficient contraception and having a negative pregnancy test.
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E.4 | Principal exclusion criteria |
Current smoker, ex-smoker who quit <1yr prior to study and smoking history >10 pack years Current use of aspirin, selective serotonin reuptake inhibitors, any other anticoagulant medication, or medication which interacts adversely with clopidogrel Diagnosis or documented history of bronchopulmonary aspergillosis or uncontrolled infections Any clinically significant cardiopulmonary abnormalities not related to pre-existing asthma Past or present tuberculosis, systemic lupus erythematosis or multiple sclerosis Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment History of psychiatric, medical or surgical disorders that may interfere with study Clinical history suggestive of respiratory infection in month preceding study Alcohol or recreational drug abuse Diagnosis of immunodeficiency requiring treatment Treatment with immunomodulators (inhaled corticosteroids in two months or oral corticosteroids in six months prior to study) Ongoing allergen desensitisation therapy Regular use of sedatives, hypnotics, tranquillisers Positive hepatitis viral antigens or antibodies Blood donation within 3 months of the study Live immunisation <4 wks prior to study Inability to understand directions for study assessment Inability to be contacted in case of emergency Participation in another study at the same time or within a prior 3-month period |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in sputum eosinophil count after allergen challenge |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
8 days after commencing 7 day course of clopidogrel |
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E.5.2 | Secondary end point(s) |
Provoking concentration of methacholine inducing 20% fall in forced expiratory volume in 1 second. Sputum concentrations of tissue factor, tissue factor inhibitor, thrombin activatable finbrinolysis inhibitor and P-selectin. Change in peripheral blood eosinophil and platelet counts. Change in urine fibrin degradation products and leukotriene E4. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
8 days after commencing 7 day course of clopidogrel |
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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 | 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 | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 2 |
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 | 2 |
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 |