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

Phase 3

Completed

• Conditions: Health Condition 1: null- Chronic Obstructive Pulmonary Disease

• Registration Number: CTRI/2009/091/000141
• Lead Sponsor: Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 860

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 a significant disease other than COPD; a significant disease is defined as

a disease which, in the opinion of the investigator, may (i) put the patient at risk

because of participation in the study, (ii) influence the results of the study, or (iii)

cause concern regarding the patientâ??s ability to participate in the study

2. 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 (a repeat

laboratory evaluation will not be conducted in these patients)

3. 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 >=ï? 600/mm3, source documentation is required to

verify that the increased eosinophil count is related to a non-asthmatic condition.

4. Patients with any of the following conditions:

- a diagnosis of thyrotoxicosis (due to the known class side effect profile of

Ã?2-agonists)

- a diagnosis of paroxysmal tachycardia ( >100 beats per minute) (due to the

known class side effect profile of Ã?2-agonists)

5. 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

6. Patients who have undergone thoracotomy with pulmonary resection (patients with a

history of thoracotomy for other reasons should be evaluated as per exclusion

criterion No. 1)

7. Patients being treated with any of the following concomitant medications:

- oral β-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

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

and in the investigatorâ??s opinion will be unable to abstain from the use of oxygen

therapy during clinic visits

9. 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

10. Patients who have taken an investigational drug within one month or six half lives

(whichever is greater) prior to screening visit (Visit 1)

11. Patients with known hypersensitivity to β-adrenergics drugs, BAC, EDTA, lactose or

any other component of the Respimat® inhalation solution or Aerolizer® DPI delivery

system

12. Pregnant or nursing women

13. Women of childbearing potential not using two

Study & Design

• Study Type: Interventional
• Study Design: Not specified