Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

Completed · Phase 2

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Key facts

Study ID

NCT00696020

Run by

Boehringer Ingelheim

People needed

360

Starts

2008-06-01

Last updated by the study team

2015-08-13

Who can join

Age: 40 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
• 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 greater or equal 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).
• Further inclusion criteria apply

You may not qualify if…

• 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
• Further exclusion criteria apply

Where it is running

• 1237.4.0118 Boehringer Ingelheim Investigational Site — Riverside, California, United States
• 1237.4.0103 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1237.4.0115 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1237.4.0105 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.4.0110 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1237.4.0117 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1237.4.0104 Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• 1237.4.0120 Boehringer Ingelheim Investigational Site — Edina, Minnesota, United States
• 1237.4.0112 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
• 1237.4.0119 Boehringer Ingelheim Investigational Site — Saint Charles, Missouri, United States
• 1237.4.0114 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 1237.4.0102 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1237.4.0111 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1237.4.0106 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1237.4.0107 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1237.4.0123 Boehringer Ingelheim Investigational Site — Knoxville, Tennessee, United States
• 1237.4.0122 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
• 1237.4.0109 Boehringer Ingelheim Investigational Site — New Braunfels, Texas, United States
• 1237.4.0108 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1237.4.0116 Boehringer Ingelheim Investigational Site — Spokane, Washington, United States
• 1237.4.0121 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1237.4.0101 Boehringer Ingelheim Investigational Site — Morgantown, West Virginia, United States
• 1237.4.0203 Boehringer Ingelheim Investigational Site — Winnipeg, Manitoba, Canada
• 1237.4.0201 Boehringer Ingelheim Investigational Site — Mississauga, Ontario, Canada
• 1237.4.0202 Boehringer Ingelheim Investigational Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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