Asthma
Conditions
Interventions
Product Name: BI 1744 solution for inhalation for the use with Respimat inhaler
Product Code: BI 1744
Pharmaceutical Form: Inhalation vapour, solution
Current Sponsor code: BI 1744 CL
Concentration ty
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients, 18 years of age or older Diagnosis of asthma (GINA) Pre-bronchodilator FEV1 greater than or equal to 60% predicted and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >80 IU/L, SGPT >80 IU/L, bilirubin >1.5XULN or creatinine >1.5XULN will be excluded regardless of clinical condition Patients with a smoking history of more than 10 pack years Patients with any of the following conditions: a diagnosis of thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse Patients being treated with any of the following concomitant medications: long acting beta-agonists (LABAs) for 2 weeks prior to Visit 1, medications that prolong the QT/QTc interval since the effects of BI 1744 CL on QT/QTc interval have yet to be characterized, oral ß-adrenergics, ß-blockers (topical ß -blockers for ocular conditions are allowed) Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2 years Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations. ;Secondary Objective: ;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint is the trough FEV1 response [L] after four weeks of treatment Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and 10 minutes prior to test-drug inhalation) at the end of the dosing interval, 23-24 hours post drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre treatment FEV1 values measured at Visit 2 (-1 hour and -10 minutes) prior to administration of the first dose of study medication. | — |
Countries
France, Germany
Outcome results
None listed