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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Long-acting beta2-agonist; Drug: Indacaterol

• Registration Number: NCT01232894
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2011-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-05-21
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Results First Posted: 2013-11-19
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-acting beta2-agonist	Long-acting beta2-agonist	Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
Indacaterol	Indacaterol	Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Primary Outcome Measures

Name	Time	Method
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score	Baseline and 12 weeks	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇱 Tel Aviv, Israel