COPD patients with moderate to severe airflow limitation MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: indacaterol
CAS Number: 753498-25-8
Other descriptive name: INDACATEROL MALEATE
Concentration unit: µg mi
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have signed an Informed Consent Form prior to initiation of any studyrelated procedure. 2. Male and female adults aged =40 years. 3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011). 4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30% and =65 years) yes F.1.3.1 Number of subjects for this age range 266
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 laboratory. These patients should not be re-screened. For more exclusion criteria, please refer to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of QVA149 27.5/12.5 µg twice a day as compared to fluticasone/salmeterol 250/50 µg twice a day in COPD patients with moderate to severe airflow limitation in terms of standardized FEV1 AUC0-12h at Week 12.;Secondary Objective: To evaluate the effect of QVA149 27.5/12.5 µg twice a day as compared to fluticasone/salmeterol 250/50µg twice a day in COPD patients with moderate to severe airflow limitation in terms of: • Lung function: • Trough FEV1 at Day 1 and Week 12 (mean of 23 h 15 min and 23 h 45 min post morning dose) • Pre-dose trough FEV1 at Week 12 (mean of 15 min and 45 min pre morning dose) • Peak FEV1 within 4 hours post dose at Day 1 and Week 12 • AUC0-4h at Day 1 and Week 12 • FEV1 and FVC bytime point at Day 1 and Week 12 • The level of breathlessness experienced by the patients evaluated using Transition Dyspnea Index (TDI) at Week 12 • The change in health status, based on total score of the St George’s Respiratory Questionnaire (SGRQ) at Week 12 as compared to baseline For more secondary objectives, please refer to the protocol;Primary end point(s): FEV1 AUC0-12h;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Lung function: • Trough FEV1 at Day 1 and Week 12 (mean of 23 h 15 min and 23 h 45 min post morning dose) • Pre-dose trough FEV1 at Week 12 (mean of 15 min and 45 min pre morning dose) • Peak FEV1 within 4 hours post dose at Day 1 and Week 12 • AUC0-4h at Day 1 and Week 12 • FEV1 and FVC bytime point at Day 1 and Week 12 • The level of breathlessness experienced by the patients evaluated using Transition Dyspnea Index (TDI) at Week 12 • The change in health status, based on total score of the St George’s Respiratory Questionnaire (SGRQ) at Week 12 as compared to baseline • The mean change from baseline in daily number of puffs of rescue medication at Week 12 • Symptoms reported at Week 12 using the patient electronic diary • COPD assessment test (CAT) at Week 12 • Safety and tolerability (electrocardiograms (ECGs), laboratory tests, vital signs and adverse events including COPD exacerbations and oral candidiasis) over 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Argentina, Belgium, Colombia, Czech Republic, India, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed