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
Article first published 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 published online: 23 SEP 2013
- Article first published 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
Table S1. Percentage of PK samples below the lower limit of quantification (LLQ) (10 pg/mL FF, 20 pg/mL VI)* by treatment and time, study Day 42 (PK population).
Please note: Wiley Blackwell is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.