Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

Launched by NOVARTIS · Nov 13, 2007

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Consented male or female adults aged ≥40 years
• • Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
• • Patients who have smoking history of at least 10 pack years
• • Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and \<80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) \<0.70 at Visit 1 and Visit 3
• Exclusion Criteria:
• • Pregnant or nursing (lactating) women
• • Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
• • Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
• • Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
• • Any history of asthma
• • Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation \[AF\]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
• • Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
• • Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (\>450 ms for males or \>470 for females)
• • History of malignancy of any organ system, treated or untreated within the past 5 years
• • Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) \>8.0% of total hemoglobin measured at Visit 1
• • Other protocol-defined inclusion/exclusion criteria may apply