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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: NVA237; Drug: QAB149; Drug: QVA149

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712516

CQVA149A2337

Details and patient eligibility

About

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

Enrollment: 1,001 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,001 participants in 4 patient groups, including a placebo group

QVA149

Experimental group

Description:

27.5/12.5 ug twice daily (b.i.d.) Single Dose Dry Powder Inhaler (SDDPI

Treatment:

Drug: QVA149

QAB149

Active Comparator group

Description:

27.5 ug b.i.d.

Treatment:

Drug: QAB149

NVA237

Active Comparator group

Description:

12.5 ug b.i.d.

Treatment:

Drug: NVA237

Placebo

Placebo Comparator group

Description:

b.i.d.

Treatment:

Drug: Placebo