Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
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 and female adults aged ≥40 years.
Patients with stable COPD according to GOLD strategy (GOLD 2011).
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator.
FEV1/FVC \< 0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC ≥ grade 2
You may not be if
History of long QT syndrome or prolonged QTc.
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of asthma or have concomitant pulmonary disease.
Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.
Clareo Health | Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
