2 results match your criteria: "Clinical Statistics (K.M.K.[Affiliation]"

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma.

N Engl J Med

September 2016

From Respiratory Clinical Development (D.A.S., A.M.Y., L.A.L., I.H.R., K.S.B., S.Y.K., S.J.P.) and Research and Development, Clinical Platforms and Sciences, Clinical Statistics (K.M.K.), GlaxoSmithKline, Research Triangle Park, Rho, Chapel Hill (H.M.), and Biostatistics, Parexel International, Durham (B.A.P.) - all in North Carolina; the Department of Pediatrics, Breathing Institute, Pediatric Pulmonary Section, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora (S.J.S., A.H.L.); the Department of Pediatrics, Center Lillebælt, Fredericia and Kolding Hospital, Odense, Denmark (S.P.); and the Department of Allergy and Research and Evaluation, Kaiser Permanente Research, San Diego, CA (R.S.Z.).

Background: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children.

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Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.

N Engl J Med

May 2016

From Respiratory Clinical Development (D.A.S., I.H.R., A.M.Y., C.M.P., K.S.B., S.J.P.) and Research and Development, Clinical Platforms and Sciences, Clinical Statistics (K.M.K., A.H.E.), GlaxoSmithKline, Durham, NC.

Background: The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate.

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