Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Intervention1: Drug: QVA149: QVA149(110/50 μg)capsules taken orally once daily throughout the 52 weeks will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Cont
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Written informed consent must be obtained before any assessment is performed •Male or female adults aged >=40 years •Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011) •Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) •Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) >=25 and •A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics •Patients taking stable COPD medication (at least 60 days) prior to day 28 •Patients with an mMRC grade of at least 2 at 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. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential •Patients with Type I or uncontrolled Type II diabetes •Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened •Patients who have a clinically significant laboratory abnormality at screening •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 •Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The rate of COPD exacerbations over 52 weeks of treatment.Timepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The time to the first COPD exacerbation over 52 weeks of treatment.Timepoint: 1.52 weeks;Rate of moderate to severe COPD exacerbations requiring treatment with antibioticsTimepoint: 52 weeks;Rate of moderate to severe COPD exacerbations requiring treatment with systemtic corticosteroidsTimepoint: 52 weeks;The rate of moderate to severe COPD exacerbations during 52 weeks of treatment.Timepoint: 52 weeks | — |
Countries
Austria, Canada, Denmark, Egypt, Germany, Iceland, India, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, South Africa, Turkey
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed