12-week Open-label Evaluation of Efficacy and Safety of Indacaterol

Novartis Pharmaceuticals90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

IndacaterolDRUG

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

Long-acting beta2-agonistDRUG

Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (8)

Novartis Investigative Site

Afula, Israel

Novartis Investigative Site

Ashkelon, Israel

Novartis Investigative Site

Holon, Israel

Novartis Investigative Site

Jerusalem, Israel

Outcomes

Primary Outcomes

Change From Baseline on Clinical COPD Questionnaire (CCQ) Score

The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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