Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or \<80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) \< 0.70 at screening.
Current or ex-smokers who have a smoking history of at least 10 pack years
Symptomatic patients according to daily diary data.
You may not be if
Pregnant or nursing (lactating) women.
Women of child-bearing potential unless using adequate contraception.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
Patients with paroxysmal (e.g. intermittent) atrial fibrillation
Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)
Clareo Health | Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
