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 |
|
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 |
|
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 |
Primary variable:·Calculated methacholine PC20 doubling concentration difference on day 7 compared to day 0 |
|
E.2.2 | Secondary objectives of the trial |
Secondary variables: Spirometry (FEV1, FVC) Calculated methacholine PC20 doubling concentration difference on day 3 compared to day 0 Adverse Events Safety lab |
|
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 asthma defined as: The patients have to suffer from allergic complaints caused by clinically relevant sensitisation against house dust mites. The IgE mediated sensitisation has to be verified by: suggestive medical history; a positive skin prick test for house dust mites, resulting in a wheal diameter of at least 3 mm > negative control reaction; or '++' versus histamine Patients with co-allergies (e.g. trees, grasses) may only be included before or after the respective pollen season - Moderate persistent asthma acc. GINA classification 2005: FEV1 = 60 to 80%predicted PC20 methacholine ≤ 4 mg / ml |
|
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 - NSAIDs - Immunosuppressant agents - Antihistamines 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 acido 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 - Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study - Patients who have difficulties in understanding the language in which the patient information is given - Any vulnerable patient (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) - 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). - Patients in custody by juridical or official order - Evidence of an uncooperative attitude - A patient who is at the same time the investigator |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the calculated PC20 doubling concentration difference on day 7 compared to day 0.
Comparison between the treatment groups will be done using a two-sided t-test at the 5% level. If a normal distribution cannot be assumed then a Wilcoxon rank-sum test will be performed (two-sided, 5% level).
The primary population for analysis will be the ITT-KPA population.
|
|
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
| No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
| |
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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |