Phase 3
Completed N=90
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Source: ClinicalTrials.gov NCT01232894 ↗Enrolled (actual)
90
Serious AEs
3.5%
Results posted
Nov 2013
Primary outcomePrimary: Change From Baseline on Clinical COPD Questionnaire (CCQ) Score — 1.8; 1.7; 1.7; 1.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on Clinical COPD Questionnaire (CCQ) Score |
1.8; 1.7; 1.7; 1.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01232894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.