E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male outpatients aged 18 - 65 with moderate persistent atopic asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003638 |
E.1.2 | Term | Atopic asthma |
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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 is the evaluation of calculated methacholine PC20 values (calculated provocative concentration of methacholine causing at least 20% reduction in FEV1) to demonstrate the efficacy of AVT-01 10 mg o.d. in comparison to placebo in a TNF-a approach resembling characteristics of severe asthma. |
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E.2.2 | Secondary objectives of the trial |
- Secondary variables: - Spirometry (FEV1, FVC)· - Calculated methacholine PC20 doubling concentration difference on day 2 compared to day 0 - Adverse Events - Safety lab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent by the patient for study participation, prior to protocol specific procedures - Male outpatients aged 18 - 65 - Atopic persistent asthma defined as: The patients have to suffer from allergic complaints caused by clinically relevant sensitisation against at least one common aeroallergen. The IgE mediated sensitisation has to be verified by: suggestive medical history; a positive skin prick test for the respective aeroallergen, resulting in a wheal diameter of at least 3 mm > negative control reaction; or '++' versus histamine - Mild persistent asthma acc. GINA classification 2005: FEV1 ≥ 80% predicted PC20 methacholine ≤ 4 mg / ml |
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E.4 | Principal exclusion criteria |
Intake of any of the following medications within the last 2 weeks prior to screening: - Systemic antibiotics - Systemic or inhaled glucocorticosteroids - Systemic or inhaled long-acting beta-agonists - Leukotriene modifiers - Nedocromil
Intake of any of the following medications during the entire study: - Systemic antibiotics - Systemic or inhaled glucocorticosteroids - Systemic or inhaled long-acting beta-agonists - Leukotriene modifiers - Nedocromil - Cromolyn sodium - Antihistamines - NSAIDs - Immunosuppressant agents - Antitussive drugs (e.g. codeine or other morphine derivatives)
Medical history or presence of any of the following organic diseases: - Acute respiratory infection (including “common cold”) in the past 4 weeks prior to screening and during the entire study - Chronic obstructive pulmonary disease (COPD) - Acute episode of COPD - Clinically relevant chronic cardiovascular disease - Chronic kidney disease - Gastrointestinal or liver diseases, such as: active peptic gastric ulcer malabsorption hypersecretion of bile acid hepatitis - Malignant growth - Severe somatopathic, neurological and/or psychiatric disease - Aortic aneurysm - Myasthenia gravis
General: - Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study - Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or [and] known drug abuse, known to be non-compliant or presenting an unstable psychiatric history) - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study - Patients in custody by juridical or official order - Evidence of an uncooperative attitude - Patients who have difficulties in understanding the language in which the patient information is given - A patient who is at the same time the investigator - Any vulnerable subject (patient who is or could be dependent on the investigator, e.g. spouse of the investigator, nurses, members of the site staff, persons who are officially/legally admitted to an institution, persons with a terminal illness, persons living in a nursing home, homeless persons, patients in emergency situations, prisoners, persons incapable of consenting) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the calculated PC20 values difference on day 2 compared to day 1 (before AVT-01 application).
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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 | 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 | 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.8.3 |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |