Authorship and contributorship
Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study
Version of Record online: 5 JUN 2013
© 2013 The Authors. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
The Clinical Respiratory Journal
Volume 7, Issue 4, pages 397–406, October 2013
How to Cite
Allen, A., Schenkenberger, I., Trivedi, R., Cole, J., Hicks, W., Gul, N. and Jacques, L. (2013), Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study. The Clinical Respiratory Journal, 7: 397–406. doi: 10.1111/crj.12026
A.A., W.H and L.J. developed the design and concept of the study, and A.A. was the study pharmacokineticist. J.C. and I.S. were study Principal Investigators at their respective investigational sites. R.T. was the clinical study investigation lead; N.G. was the lead statistical contact.
The study was approved by local ethics review committees and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from each patient prior to the performance of any study-specific procedures.
Conflict of interest
J.C. has received investigator and travel fees for his role in conducting multicentre clinical trials organised by GlaxoSmithKline, administered by his employer facility IPS Research, which has also received site funding and support in association with such trials, which include the study described in this work. I.S. declares no conflicts of interest.A.A., R.T., W.H., N.G. and L.J. are employees of and hold stock/shares in GlaxoSmithKline. All authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors, had full access to and interpreted the data, and wrote the manuscript. All authors vouch for the accuracy and completeness of the data and the data analysis.
This study was funded by GlaxoSmithKline (GSK study number HZA106851; http://www.clinicaltrials.gov registration number NCT01086410).
- Issue online: 23 SEP 2013
- Version of Record online: 5 JUN 2013
- Accepted manuscript online: 12 APR 2013 04:09AM EST
- Manuscript Accepted: 7 APR 2013
- Manuscript Revised: 4 APR 2013
- Manuscript Received: 18 JAN 2013
- GlaxoSmithKline. Grant Number: HZA106851
- 1Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2011. Available at: http://www.ginasthma.com/ (accessed 10 January 2013).
- 15National Institutes for Health (NIH). Guidelines for the Diagnosis and Management of Asthma – Expert Panel Report 3, 2007. Bethesda, MD, U.S. Department of Health and Human Services, 2007. NIH Publication No. 07-4051.
- 18The safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled fluticasone furoate (FF) and vilanterol (VI) are unaffected by administration in combination. Eur Respir J. 2011;38(Suppl. 55): 824s. [abstract]., , , , , .
- 19The absolute bioavailability of fluticasone furoate (FF) and vilanterol (VI) trifenatate following inhaled administration in combination in healthy subjects. Eur Respir J. 2011;38(Suppl. 55): 3976s. [abstract]., , , , .