Professor Alyn Morice A.H.Morice@hull.ac.uk
Foundation Chair and Professor of Respiratory Medicine
Theobromine for the treatment of persistent cough: A randomised, multicentre, double-blind, placebo-controlled clinical trial
Morice, Alyn H.; McGarvey, Lorcan; Pavord, Ian D.; Higgins, Bernard; Chung, Kian Fan; Birring, Surinder S.
Authors
Lorcan McGarvey
Ian D. Pavord
Bernard Higgins
Kian Fan Chung
Surinder S. Birring
Abstract
© Journal of Thoracic Disease. Background: To investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity. Methods: This was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests. Results: At baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P < 0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (-12.2±23.28 in BC1036 group and -11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups. Conclusions: This study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity. Clinical trial registration: ClinicalTrials.gov: NCT01656668.
Citation
Morice, A. H., McGarvey, L., Pavord, I. D., Higgins, B., Chung, K. F., & Birring, S. S. (2017). Theobromine for the treatment of persistent cough: A randomised, multicentre, double-blind, placebo-controlled clinical trial. Journal of thoracic disease, 9(7), 1864-1872. https://doi.org/10.21037/jtd.2017.06.18
Journal Article Type | Article |
---|---|
Acceptance Date | May 18, 2017 |
Online Publication Date | Jul 1, 2017 |
Publication Date | Jul 1, 2017 |
Deposit Date | Apr 25, 2019 |
Publicly Available Date | Oct 5, 2020 |
Journal | Journal of Thoracic Disease |
Print ISSN | 2072-1439 |
Electronic ISSN | 2077-6624 |
Peer Reviewed | Peer Reviewed |
Volume | 9 |
Issue | 7 |
Pages | 1864-1872 |
DOI | https://doi.org/10.21037/jtd.2017.06.18 |
Keywords | Cocoa; Controlled clinical trial; Cough; Quality of life (QOL); Theobromine |
Public URL | https://hull-repository.worktribe.com/output/1647034 |
Publisher URL | http://jtd.amegroups.com/article/view/14426/11962 |
Files
Published article
(271 Kb)
PDF
Publisher Licence URL
https://creativecommons.org/licenses/by-nc-nd/4.0/
You might also like
Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey
(2023)
Journal Article
Downloadable Citations
About Repository@Hull
Administrator e-mail: repository@hull.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search