Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Launched by NOVARTIS PHARMACEUTICALS · Dec 10, 2007

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• • 2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
• • 3. Patients who have smoking history of at least 10 pack years.
• • 4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.70.
• Exclusion Criteria:
• • 1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
• • 2. 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 department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
• • 3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
• • 4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
• • 5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
• • 6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
• • 7. Patients with uncontrolled Type I and Type II diabetes.
• • 8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
• • 9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
• • 10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (\>450 ms for males or \>470 ms for females).
• • 11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.
• • Other protocol-defined inclusion/exclusion criteria may apply.