These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

  • Title: Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: a randomised trial.
    Author: Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PM.
    Journal: Respir Med; 2013 Apr; 107(4):550-9. PubMed ID: 23332861.
    Abstract:
    BACKGROUND: Once-daily combination treatment is an attractive maintenance therapy for COPD. However, the dose of inhaled corticosteroid to use in a once-daily combination is unknown. We compared two strengths of fluticasone furoate (FF) plus vilanterol (VI), the same strengths of the individual components, and placebo. METHODS: Multicentre, randomised, 24-week, double-blind, placebo-controlled, parallel-group study in stable, moderate-to-severe COPD subjects (N = 1224). Subjects were randomised to FF/VI (200/25 μg; 100/25 μg), FF (200 μg; 100 μg), VI 25 μg, or placebo, once daily in the morning. Co-primary efficacy endpoints; 0-4 h weighted mean (wm) FEV(1) on day 168, and change from baseline in trough (23-24 h post-dose) FEV(1) on day 169. The primary safety objective was adverse events (AEs). RESULTS: There was a statistically significant (p < 0.001) increase in wm FEV(1) (209 ml) and trough FEV(1) (131 ml) for FF/VI 200/25 μg vs. placebo; similar changes were seen for FF/VI 100/25 μg vs. placebo. Whereas the difference between FF/VI 200/25 μg and VI 25 μg in change from baseline trough FEV(1) (32 ml) was not statistically significant (p = 0.224), the difference between FF/VI 200/25 μg and FF 200 μg for wm FEV(1) (168 ml) was significantly different (p < 0.001). VI 25 μg significantly improved wm and trough FEV(1) vs. placebo (185 ml and 100 ml, [corrected] respectively). No increase was seen in on-treatment AEs or serious AEs (SAEs), with active therapy vs. placebo. CONCLUSIONS: FF/VI provides rapid and significant sustained improvement in FEV(1) in subjects with moderate-to-severe COPD, which was not influenced by the dose of FF. These data suggest that FF/VI may offer clinical efficacy in COPD and warrants additional study. GSK study number: HZC112207. ClinicalTrials.gov: NCT01054885.
    [Abstract] [Full Text] [Related] [New Search]