Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo to NVA237 and indacaterol 150 µg; Drug: NVA237 50 µg and indacaterol 150 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01604278

2011-005673-23 (EudraCT Number)

CNVA237A2316

Details and patient eligibility

About

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Enrollment: 449 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
• Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
• Current or ex-smokers who have a smoking history of at least 10 pack years
• Symptomatic patients according to daily diary data.

Exclusion criteria

• Pregnant or nursing (lactating) women.
• Women of child-bearing potential unless using adequate contraception.
• Patients with Type I or uncontrolled Type II diabetes.
• Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
• Patients with paroxysmal (e.g. intermittent) atrial fibrillation
• Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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449 participants in 2 patient groups, including a placebo group

NVA237 + indacaterol

Active Comparator group

Treatment:

Drug: NVA237 50 µg and indacaterol 150 µg

Placebo to NVA237 + indacaterol

Placebo Comparator group

Treatment:

Drug: Placebo to NVA237 and indacaterol 150 µg