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: QVA149; Drug: NVA237; Drug: QAB149

Study type: Interventional

Funder types: Industry

Identifiers

NCT01727141

CQVA149A2336

Details and patient eligibility

About

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

Full description

NOTE: Detailed Description: data not entered

Enrollment: 1,042 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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1,042 participants in 4 patient groups, including a placebo group

QVA149

Experimental group

Description:

27.5/12.5 ug twice daily (b.i.d.) via 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