Overview

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Formoterol Fumarate
Olodaterol
Criteria
Inclusion criteria:

1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must
meet the following spirometric criteria:post-bronchodilator FEV1<80% of predicted
normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1

2. Male or female patients, 40 years of age or older

3. Patients must be current or ex-smokers with a smoking history of more than 10 pack
years:

Exclusion criteria:

1. 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

2. Patients with a history of asthma and/or total blood eosinophil count greater than
600/mm3

3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)

4. Patients with a history of myocardial infarction within 1 year of screening visit,
unstable or life-threatening cardiac arrhythmia, hospitalization 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,
life-threatening pulmonary obstruction, cystic fibrosis, clinically evident
bronchiectasis, significant alcohol or drug abuse

5. Patients who have undergone thoracotomy with pulmonary resection

6. Patients being treated with oral beta-adrenergics or 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.

7. Patients who regularly use daytime oxygen therapy for more than one hour per day.

8. 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

9. Pregnant or nursing women

10. Women of childbearing potential not using two effective methods of birth control (one
barrier and one non-barrier).