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 Sever

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bromides; Glycopyrrolate; Maleic acid

Criteria

Inclusion Criteria:

• Male and female patients that have signed informed consent and are >/= 40 years of age.

• Patients with stable COPD according to GOLD 2011.

• Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.

• Current or ex-smokers who have a smoking history of at least 10 pack years.

• Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

• Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (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 ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)

• Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.

• Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.

• Patients who had a COPD exacerbation within 6 weeks prior to screening.

• Patients who have a respiratory tract infection within 4 weeks prior to screening.

• Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.

• Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.

• Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.

• Patients with concomitant pulmonary disease.

• Patients with a diagnosis of alpha-1 anti-trypsin deficiency.

• Patients with active pulmonary tuberculosis.

• Patients in the active phase of a pulmonary rehabilitation programme.

• Other protocol-defined inclusion/exclusion criteria may apply