Overview

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 QVA149 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