Novartis CQVA149A2337.
| Trial name or title | A 12‐Week Treatment, Multi‐center, Randomized, Double‐blind, Parallel‐group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation |
| Methods | Randomized, double‐blind, parallel‐group, placebo and active controlled study |
| Participants | Male and female patients who have signed informed consent and are ≥ 40 years of age Patients with stable chronic obstructive pulmonary disease (COPD) according to GOLD 2011 Patients with a postbronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% predicted and a postbronchodilator FEV1/forced vital capacity (FVC) < 0.70 Current smokers or ex‐smokers who have a smoking history of at least 10 pack‐years Patients with an mMRC grade 2 or greater |
| Interventions | LABA/LAMA Long‐acting muscarinic antagonist (LAMA) Placebo Long‐acting beta2‐agonist (LABA) |
| Outcomes |
Primary outcome: Standardized forced expiratory volume in 1 second (FEV1) Area under the curve (AUC) following 12 weeks of treatment Secondary outcomes: Change in health status based on total score and percentage of participants with clinically significant improvement, as reported by participants using the St George Respiratory Questionnaire (SGRQ) following 12 weeks of treatment Trough forced expiratory volume in 1 second (FEV1) following 12 weeks of treatment Level of breathlessness experienced by participants evaluated using the Transitional Dyspnoea Index (TDI) following 12 weeks of treatment Medication use (number of puffs) reported by participants using the patient electronic diary following 12 weeks of treatment Evaluation of symptoms reported using the patient electronic diary following 12 weeks of treatment Evaluation of forced expiratory volume in 1 second (FEV1) at all time points Evaluation of forced vital capacity (FVC) at all time points |
| Starting date | December 2012 |
| Contact information | Novartis Pharmaceuticals |
| Notes |
AUC: area under the curve; COPD: chronic obstructive pulmonary disease; GOLD: Global Initiative or Chronic Obstructive Lung Disease; FEV1: forced expiratory volume in 1 second ;FVC: forced vital capacity; LABA: long‐acting beta2‐agonist; LAMA: long‐acting muscarinic agonist; mMRC: modified Medical Research Council; SGRQ: St George's Respiratory Questionnaire; TDI: Transitional Dyspnoea Index.