Status:
COMPLETED
BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructi...
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 COPD and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \< 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
- Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
Exclusion
- Patients with a significant disease other than COPD.
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \> x2 ULN, SGPT \> x2 ULN, bilirubin \> x2 ULN or creatinine \> x2 ULN will be excluded regardless of clinical condition.
- Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count more than 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
- Patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period.
- Patients with any of the following conditions: a diagnosis of thyrotoxicosis; a diagnosis of paroxysmal tachycardia (\>100 beats per minute)
- Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (Visit 1); unstable or life-threatening cardiac arrhythmia; have been hospitalized for heart failure within the past year; 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 being treated with any of the following concomitant medications: oral beta2-adrenergics; oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
- Patients who regularly use daytime oxygen therapy for more than one hour per day.
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
- Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
- Pregnant or nursing women
- Women of childbearing potential not using two effective methods of birth control (one barrier, 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00846768
Start Date
February 1 2009
Last Update
July 1 2014
Active Locations (5)
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1
1222.26.32008 Boehringer Ingelheim Investigational Site
Genk, Belgium
2
1222.26.32006 Boehringer Ingelheim Investigational Site
Ghent, Belgium
3
1222.26.32007 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
4
1222.26.31002 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands