Efficacy and safety of AVT-01 5 mg once daily over 7 days in patients with moderate persistent atopic asthma – A double-blind, randomized, placebo-controlled clinical study

INTERVENTION: Product Name: AVT‐01 Product Code: AVT‐01 Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use CONDITION: Male outpatients aged 18 ‐ 65 with moderate persistent atopic asthma ; MedDRA version: 8.1 Level: LLT Classification code 10003638 Term: Atopic asthma PRIMARY OUTCOME: Main Objective: Primary variable:·Calculated methacholine PC20 doubling concentration difference on day 7 compared to day 0 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.; Secondary Objective: Secondary variables:; Spirometry (FEV1, FVC); Calculated methacholine PC20 doubling concentration difference on day 3 compared to day 0; Adverse Events; Safety lab 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