Randomised, double-blind, double-dummy, placebo-controlled, 4-way cross-over study to characterise the 24-hour FEV1-time profiles of BI 1744 CL 5µg and 10µg (oral inhalation, delivered by the Respimat® Inhaler) and tiotropium bromide 18µg (oral inhalation, delivered by the HandiHaler®) after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 12.0Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2009-014417-27-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-12
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

provision of informed consent

diagnosis of chronic obstructive pulmonary disease

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

smoker or ex-smokers with a smoking history of more than 10 pack years

ability to perform technically acceptable pulmonary function tests

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Significant disease other than COPD

Clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis

SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN

History of asthma

Following conditions:diagnosis of thyrotoxicosis, diagnosis of paroxysmal tachycardia (>100 beats per minute), a history of myocardial infarction within 1 year of screening visit (Visit 1), unstable or life-threatening cardiac arrhythmia. hospitalization for heart failure within the past year, known active tuberculosis, a malignancy (resection, radiation therapy or chemotherapy within last five years; treated basal cell carcinoma accepted), history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis and history of significant alcohol or drug abuse

Undergone thoracotomy with pulmonary resection

Following concomitant medications: oral ß-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, regularly use daytime oxygen therapy for more than one hour per day, completed pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or current pulmonary rehabilitation program, treatment with investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)

Known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the medications

Pregnant or nursing women

Women of childbearing potential not using two effective methods of birth control

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified