Asthma MedDRA version: 12.0 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of informed consent consistent Male or female patients, aged between 18 and 70 years of age, diurnally active A history of asthma diagnosed by physician at least 3 months prior to Visit 1 Pre-bronchodilator FEV1 =60% predicted and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Significant disease other than asthma Hospitalisation for an asthma exacerbation within 3 months or had an admission to an intensive care unit for asthma within 3 years of Visit 1 AST>80 IU/L, ALT >80 IU/L, bilirubin >1.5 X ULN or creatinine >1.5 X ULN or clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis based The following conditions: thyrotoxicosis, a diagnosis of paroxysmal tachycardia, marked baseline prolongation of QT/QTc interval at Visit 1, a history of additional risk factors for Torsade de Pointes The following conditions: history of myocardial infarction within 1 year of screening, clinically relevant cardiac arrhythmia, cor pulmonale, active tuberculosis, malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, COPD, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse The following concomitant medications: long acting beta-agonists (LABAs) within 48 hours prior to screening, oral or other systemic corticosteroids in the 6 weeks prior to screening, Anti-IgE antibodies for 6 months prior to screening, medications that prolong the QT/QTc interval, oral ß-adrenergics for 6 weeks prior to screening,ß-blockers, methylxanthines and antileukotrienes in the 6 weeks prior to screening, short-acting anticholinergics (6 hours beofree screening) and long-acting anticholinergics (e.g. Tiotropium (Spiriva®)) in the 6 weeks prior to screening Start of immunotherapy (desensitisation therapy) within two years and are not on stable dose. Known hypersensitivity to study medtcions Pregnant or nursing patients Patients of childbearing potential not using a highly effective method of birth control. Patients with frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years) Patients with any asthma exacerbation or respiratory tract infection in the four weeks prior to the Screening Visit (Visit 1) or during the 2-week baseline period. Patients whose compliance using the AM2+® device is less than 80% during baseline period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo. An optimum dose may be selected based on bronchodilator efficacy and safety evaluations of BI 1744 CL.;Secondary Objective: A secondary objective of this study is to compare the 24-hour FEV1 time profile of BI 1744 CL (2µg, 5µg, 10µg and 20µg) administered once daily by the Respimat® inhaler with the 24-hour FEV1 time profile of Foradil® powder capsule (12µg) administered twice daily via the Aerolizer® inhaler after 4 weeks of treatment.;Primary end point(s): The primary efficacy variable will be the forced expiratory volume in one second (FEV1). The primary endpoint is the FEV1 area under the curve (AUC) 0-24 hours (AUC 0-24h) (L) determined at the end of each 4 week treatment period. | — |
Countries
Austria, Germany, Slovenia
Outcome results
None listed