Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial.

BACKGROUND AND OBJECTIVE: Combination long-acting ß2 -agonist/long-acting muscarinic antagonist (LABA/LAMA) has demonstrated superior clinical outcomes over LABA/inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD) patients; however, data from blinded randomized controlled trials on direct switching from LABA/ICS to LABA/LAMA are lacking. FLASH (Assessment of switching salmeterol/Fluticasone to indacateroL/glycopyrronium in A Symptomatic COPD patient coHort) investigated if direct switch, without a washout period, from salmeterol/fluticasone (SFC) to indacaterol/glycopyrronium (IND/GLY) in COPD patients improves lung function and is well tolerated. METHODS: In this 12-week, multicentre, double-blind study, patients with moderate-to-severe COPD and up to one exacerbation in previous year, receiving SFC for ≥3 months, were randomized to continue SFC 50/500 µg twice daily (bd) or switch to IND/GLY 110/50 µg once daily (od). Primary endpoint was pre-dose trough forced expiratory volume in 1 s (FEV1 ) at Week 12. RESULTS: In total, 502 patients were randomized (1:1) to IND/GLY or SFC. Patients switched to IND/GLY demonstrated superior lung function (pre-dose trough FEV1 ) versus SFC at Week 12 (treatment difference (Δ) = 45 mL; P = 0.028). IND/GLY provided significant improvements in pre-dose trough forced vital capacity (FVC; Δ = 102 mL; P = 0.002) and numerical improvements in transition dyspnoea index (TDI; Δ = 0.46; P = 0.063). Rescue medication use and COPD assessment test (CAT) scores were comparable between groups. Both treatments had similar safety profiles. CONCLUSION: FLASH demonstrated that a direct switch to IND/GLY from SFC improved pre-dose FEV1 and FVC in COPD patients with up to one exacerbation in the previous year. No new safety signals were identified.

Proinflammatory cytokines in Egyptian elderly with chronic obstructive pulmonary disease.

BACKGROUND: The pulmonary component of chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases. HYPOTHESIS: The levels of the proinflammatory cytokines, interleukin 1 beta (IL-1ß), tumor necrosis factor alfa (TNF-α), and C-reactive protein (CRP), in elderly patients suffering from COPD are increased. SETTINGS AND DESIGN: A case control study involving 90 elderly participants from the outpatient clinics of Ain Shams University hospitals. MATERIALS AND METHODS: The 90 subjects were subdivided into three equal groups ' group I (control), group II (patients with COPD), and group III (patients with COPD and cardiovascular complications). Comprehensive clinical assessment, pulmonary functions, and echocardiography were performed. The levels of IL-1ß, TNF-α, and CRP were measured in the patients' serum and compared. STATISTICAL ANALYSIS: SPSS (Statistical Package for Social Science) version 10. RESULTS: IL1-ßand CRP were significantly higher in the third group than the first group (P <0.05). There was a similar significant difference between the second and third group as regards IL1-ßand CRP (P < 0.05). Positive significant correlation between CRP and TNF-α with stage of COPD according to FEV1 (P <0.05) were found. CONCLUSIONS: Complicated cases of COPD had higher levels of IL1-ß and CRP and the more severe the cases, the higher the levels of CRPand TNF-α.