Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy (Bronchodilation) and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (4 Doses) Delivered by the Respimat® Inhaler in Patients With Asthma
- NCT00467740
- PHASE2
- INTERVENTIONAL
Last updated: 2014-06-27
Purpose of Trial
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).
This study is for people with
Asthma
Interventions being studied
BI 1744 CL
Inclusion Criteria:
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
2. Male or female patients, 18 years of age or older
3. Diagnosis of asthma (GINA)
4. Pre-bronchodilator FEV1 greater than or equal to 60% predicted and \<90% predicted (ECSC);
5. Increase in FEV1 greater than or equal to 12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at Visit 1
6. Patient must have been taking Inhaled Corticosteroids for at least 12 weeks prior to screening, and must have been receiving a stable low/moderate dose for at least 6 weeks prior to screening.
7. Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
8. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI).
Exclusion Criteria:
1. Patients with a smoking history of more than 10 pack years
2. Patients with any of the following conditions: a diagnosis of thyrotoxicosis, a diagnosis of 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)
3. Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (Visit 1), 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
4. Patients who have undergone thoracotomy with pulmonary resection
5. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
6. Pregnant or nursing women
7. Women of childbearing potential not using a highly effective method of birth control. 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
8. Patients who have previously been randomized in this study or are currently participating in another study
9. Patients who are unable to comply with pulmonary medication restrictions prior to randomization
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
10 Locations
Lakewood
1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood
California, United States
Los Angeles
1222.6.062 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC
California, United States
San Diego
1222.6.069 Allergy Associates Medical Group
California, United States
Denver
1222.6.068 National Jewish Medical Center
Colorado, United States
Wheat Ridge
1222.6.073 Boehringer Ingelheim Investigational Site
Colorado, United States
North Darthmouth
1222.6.067 Northeast Medical Research Associates, Inc
Massachusetts, United States
Winston-Salem
1222.6.061 Center for Human Genomics
North Carolina, United States
Kileen
1222.6.072 Boehringer Ingelheim Investigational Site
Texas, United States
Tacoma
1222.6.071 Pulmonary Consultants
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov