Male outpatients aged 18 - 65 with moderate persistent atopic asthma MedDRA version: 8.1 Level: LLT Classification code 10003638 Term: Atopic asthma
Conditions
Sponsors
Avontec GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 the Wilcoxon rank-sum test will be performed (two-sided, 5% level). The primary population for analysis will be the ITT-KPA population. ;Main Objective: Primary variable:·Calculated methacholine PC20 doubling concentration difference on day 7 compared to day 0;Secondary Objective: Secondary variables: Spirometry (FEV1, FVC) Calculated methacholine PC20 doubling concentration difference on day 3 compared to day 0 Adverse Events Safety lab | — |
Countries
United Kingdom
Outcome results
None listed