Status:
COMPLETED
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once...
Eligibility Criteria
Inclusion
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \>= 30% of predicted normal and \<80% of predicted normal and a post-bronchodilator FEV1 / FVC \<70% at Visit 1
- Male or female patients, 40 years of age or older
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years
- 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).
- additional inclusion criteria apply.
Exclusion
- Patients with a significant disease other than COPD
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count \>= 600/mm3.
- 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 QTcF\* 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, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, 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 regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
- Pregnant or nursing women
- Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). 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 two 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
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
- additional exclusion criteria apply.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00720499
Start Date
July 1 2008
Last Update
August 17 2015
Active Locations (24)
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1
1237.9.00152 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
2
1237.9.00155 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
3
1237.9.00151 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
4
1237.9.00154 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States