A Study to Compare the Effect of QVA149 With Salmeterol/Futicasone n the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- CTRI/2014/01/004365
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3332
•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 < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
•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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method