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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.


Alyn H. Morice

Lorcan McGarvey

Ian D. Pavord

Bernard Higgins

Kian Fan Chung

Surinder S. Birring


© 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: NCT01656668.

Journal Article Type Article
Publication Date Jul 1, 2017
Journal Journal of Thoracic Disease
Print ISSN 2072-1439
Electronic ISSN 2077-6624
Peer Reviewed Peer Reviewed
Volume 9
Issue 7
Pages 1864-1872
APA6 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.
Keywords Cocoa; Controlled clinical trial; Cough; Quality of life (QOL); Theobromine
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