subjects with moderate to very severe COPD MedDRA version: 14.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Product Name: indacaterol maleate/glycopyrronium bromide
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: indacaterol
CAS Number: 753498-25-8
Current Spo
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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: • Total abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception). • Female sterilization defined as surgical hysterectomy, bilateral oophorectomy, or tubal ligation at least six weeks before taking the study treatment (Single oophorectomy does not meet the definition of female sterilization). • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. • Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate 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. 8. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective bet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that QVA149 (110/50 µg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 µg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.;Secondary Objective: To demonstrate that QVA149 (110/50 µg o.d.) is superior to salmeterol/fluticasone (50/500 µg b.i.d.) in terms of rate of all COPD exacerbations during 52 weeks of treatment. To evaluate the effect of QVA149 compared to salmeterol/fluticasone during 52 weeks of treatment in terms of: • Time to first COPD exacerbation (mild/moderate/severe). • Rate and time to first moderate/severe COPD exacerbations. To evaluate the effect of QVA149 compared to salmeterol/fluticasone in terms of: • FEV1 and FVC on Day 1 and after 4, 12, 26, 38 and 52 weeks of treatment. • Lung function in terms of standardized FEV1 AUC (0 – 12h), in a subset of patients. • Total score of the St. George’s Respiratory Questionnaire (SGRQ-C) after 4, 12, 26, 38 and 52 weeks of treatment • Mean use of rescue therapy over the 52 weeks treatment period. ;Primary end point(s): Rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment;Timepoint(s) of evaluation of this end point: week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Time to first COPD exacerbation (mild/moderate/severe). •Rate and time to first moderate/severe COPD exacerbations. •Rate and time to first moderate to severe COPD exacerbation requiring: • systemic glucocorticosteroids during the treatment period • antibiotics during the treatment period • hospitalizations during the treatment period. • rehospitilisation within 30 days during the treatment period. •FEV1 (including morning pre-dose FEV1) and FVC on Day 1 and after 4, 12, 26, 38 and 52 weeks of treatment. •Standardized FEV1 AUC (0 – 12h), in a subset of patients. •Total score of the St. George’s Respiratory Questionnaire (SGRQ-C) after 4, 12, 26, 38 and 52 weeks of treatment •Mean use of rescue therapy over the 52 weeks treatment period. •Safety - ECG, laboratory tests, vital signs and adverse events •24-hour weighted mean urine cortisol, in a sub-set of patients. ;Timepoint(s) of evaluation of this end point: week 52 | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom
Contacts
Public ContactDRA Department
Novartis Slovakia s.r.o.
Outcome results
None listed