NVA237 Versus Placebo 12-week Efficacy Study

Launched by NOVARTIS PHARMACEUTICALS · Oct 16, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011).
• • 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and \<80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) \< 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.
• • 3. Current or ex-smokers with at least 10 cigarette pack years smoking history.
• Exclusion criteria:
• • 1. Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
• • 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• • 3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
• • 4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
• • 5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
• • 6. Patients with a body mass index (BMI) of more than 40 kg/m2.
• • 7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
• • 8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.
• • Other protocol-defined inclusion/exclusion criteria may apply.