Randomised, Double-Blind, Placebo-Controlled, Parallel Group Studyto Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatmentof Orally Inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) Delivered bythe Respimat® Inhaler in Patients with COPD

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 8.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2006-004828-36-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-21
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. All patients must have a diagnosis of chronic obstructive pulmonary disease (P06-12085) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 > 30% of predicted normal and < 80% of predicted normal [ECSC, R94-1408] and a post-bronchodilator FEV1 / FVC < 70% at Visit 1 [See Section 5.1 for ECSC predicted normal equations]
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

Pack Years = (Number of cigarettes/day)/20 x years of smoking

Patients who have never smoked cigarettes must be excluded
4. Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEFR measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
5. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix 1) and from a metered dose inhaler (MDI).

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

1. Patients with a significant disease other than COPD;
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > 80 IU/L, SGPT > 80 IU/L, bilirubin > 17 µmol/L or creatinine >110 µmol/L (males) / 95 µmol/L (females) will be excluded regardless of clinical condition;
3. Patients with a history of asthma or a total blood eosinophil count ³ 600/mm3;
4. 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 QTc 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);
5. 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 (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
7. Patients being treated with any of the following concomitant medications:
–medications that prolong the QT/QTc interval
–oral ß-adrenergics
–ß-blockers (topical ß -blockers for ocular conditions are allowed)
–oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose)

Study & Design

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