Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
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
Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
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) \< 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations \[Quanjer PH 1993\], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables \[Japan Respiratory Society 2001\].
You may not be if
Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
Patients with a history of asthma indicated by (but not limited to):
1. Blood eosinophil count \> 400/mm3
2. Onset of symptoms prior to age 40 years.
Clareo Health | Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
