12-week Open-label Evaluation of Efficacy and Safety of Indacaterol (MOVE-ON)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol; Drug: Long-acting beta2-agonist

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232894

CQAB149BIL01

Details and patient eligibility

About

In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

Enrollment: 90 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
• Post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70%
• Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

Exclusion criteria

• Patients with a history of asthma
• Patients who are currently being treated for COPD with tiotropium (Spiriva®)
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Indacaterol

Experimental group

Description:

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Treatment:

Drug: Indacaterol

Long-acting beta2-agonist

Active Comparator group

Description:

Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy

Treatment:

Drug: Long-acting beta2-agonist