None listed
Conditions
Interventions
Patients will be assigned to one of the following 2 blinded treatment arms in a ratio of 1:1
1. QVA149 (110/50 μ
g) once daily
2. Salmeterol/fluticasone (50/500μ
g) b.i.d
Patients, investigator staff, persons performing the assessments, and data analysts will remain
blind to the identity of the treatment from the time of randomization until database lock
(2) The identity of the treatments will be concealed by the use of investigational treatment that
are identical in packaging, labeling, schedule of administration and appearance.
A double-dummy
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Written informed consent must be obtained before any assessment is performed. 2. Male or female adults aged ≥40 years. 3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011). 4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years). 5. Patients with a post-bronchodilator FEV1 ≥25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28). (Post refers to 1 h after sequential inhalation of 84 μg (or equivalent dose) of ipratropium bromide and 400 μg of salbutamol). 6. A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics. 7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101. 8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).
Exclusion criteria
Exclusion criteria: Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include. Patients with Type I or uncontrolled Type II diabetes. 4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened. 5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201. (These patients should not be re-screened) 6. Patients who have a clinically significant laboratory abnormality at Visit 101. 7. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment.
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Finland, France, Germany, India, Japan, Korea South, Mexico, Peru, Poland, Russian Federation, Spain, Switzerland, Taiwan, Thailand, Turkey
Contacts
Public ContactOscar Barreneche
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed