Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients

Launched by NOVARTIS PHARMACEUTICALS · May 8, 2015

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with airflow limitation indicated by a post-bronchodilator FEV1 \<80% of the predicted normal value and a post-bronchodilator FEV1/FVC\<0.7
• • Current or ex-smokers who have a smoking history of at least 10 pack years.
• • Able and willing to give written informed consent
• • Hyperinflated patients with RVol\>135% predicted
• Exclusion Criteria:
• • Patients on LABA or LAMA treatment at Visit 1.
• • History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.
• • More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.
• • Patients who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction \<40% as determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 2)
• • Patients with a known history or current atrial fibrillation to be confirmed by ECG.
• • Patients with pacemaker, bypass or stent.
• • Patients whose QTcF measured at Visit 3 is \>450 ms for males and \>470 ms for females
• • Additional study-specific inclusion and exclusion criteria may apply