Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma

Completed · Phase 2

Conditions studied: Asthma

In brief

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).

Key facts

Study ID: NCT00467740
Run by: Boehringer Ingelheim
People needed: 296
Starts: 2007-05-01
Last updated by the study team: 2014-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
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 <90% predicted (ECSC);
Increase in FEV1 greater than or equal to 12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at Visit 1
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.
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
Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI).

You may not qualify if…

Patients with a smoking history of more than 10 pack years
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)
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
Patients who have undergone thoracotomy with pulmonary resection
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
Pregnant or nursing women
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
Patients who have previously been randomized in this study or are currently participating in another study
Patients who are unable to comply with pulmonary medication restrictions prior to randomization

Where it is running

1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood — Lakewood, California, United States
1222.6.062 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC — San Diego, California, United States
1222.6.069 Allergy Associates Medical Group — San Diego, California, United States
1222.6.068 National Jewish Medical Center — Denver, Colorado, United States
1222.6.073 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
1222.6.067 Northeast Medical Research Associates, Inc — North Darthmouth, Massachusetts, United States
1222.6.061 Center for Human Genomics — Winston-Salem, North Carolina, United States
1222.6.072 Boehringer Ingelheim Investigational Site — Kileen, Texas, United States
1222.6.071 Pulmonary Consultants — Tacoma, Washington, United States
1222.6.017 Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
1222.6.006 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
1222.6.012 Boehringer Ingelheim Investigational Site — Winnipeg, Manitoba, Canada
1222.6.016 Boehringer Ingelheim Investigational Site — Winnipeg, Manitoba, Canada
1222.6.011 Boehringer Ingelheim Investigational Site — Hamilton, Ontario, Canada
1222.6.003 Boehringer Ingelheim Investigational Site — Mississauga, Ontario, Canada
1222.6.013 Boehringer Ingelheim Investigational Site — Ottawa, Ontario, Canada
1222.6.005 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
1222.6.009 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada
1222.6.008 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
1222.6.015 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
1222.6.007 Boehringer Ingelheim Investigational Site — Sherbrooke, Quebec, Canada
1222.6.002 Boehringer Ingelheim Investigational Site — Ste-Foy, Quebec, Canada
1222.6.004 Boehringer Ingelheim Investigational Site — Saskatoon, Saskatchewan, Canada
1222.6.3303A Boehringer Ingelheim Investigational Site — Béthune, France

Full record on ClinicalTrials.gov

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