J Rhinol.
2011 Nov;18(2):128-134.
Efficacy and Tolerability of Theobromine in Patients with Upper Airway Cough Syndrome: A Multicenter, Double-Blind, Randomized, Active Drug Comparative Study
- Affiliations
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- 1Department of Otorhinolaryngology Head & Neck Surgery, Yeouido St. Mary's Hospital, Korea. entcho@catholic.ac.kr
- 2Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- 3Department of Otorhinolaryngology Head & Neck Surgery, Severance Hospital, Korea.
- 4Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 5Department of Otorhinolaryngology Head & Neck Surgerym Korea University Anam Hospital, Korea.
- 6Korea University College of Medicine, Guro Hospital, Seoul, Korea.
Abstract
OBJECTIVES
The objective of this study is to evaluate the efficacy and tolerability of theobromine in patients with upper airway cough syndrome compared to those of levocloperastine. MATERIALS AND METHOD: This was a randomized, double-blind study. One hundred sixty-five patients with upper airway cough syndrome participated in a 5 day treatment; 85 subjects were included in the theobromine treatment group and 80 in the levocloperastine control group. Cough severity score, daytime cough symptom (DCS), nighttime cough symptom (NCS) and cough quality of life questionnaire (CQLQ) were analyzed for symptom analysis, and vital signs and laboratory study were performed for safety evaluation before and after medication administration.
RESULTS
The primary efficacy analysis showed that the mean change in cough grade between baseline and follow-up in the treatment group was lower than that in the control group. This led to the conclusion that theobromine has similar efficacy to control treatment. The secondary efficacy analysis of changes in DCS, NCS and CQLQ verified this conclusion. Considering safety, only one case of dyspepsia was considered to be probably related to theobromine. Other tests conducted before and after treatment confirmed the safety of treatment medications.
CONCLUSION
Theobromine is a novel natural antitussive medication that has similar efficacy to levocloperastine and adequate safety.
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