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The Efficacy of Bradanicline in Refractory Chronic Cough

Yoshihiro Kanemitsu, Jaclyn Smith, Peter Butera, Brendan Canning, Peter Dicpinigaitis, Vivek Iyer, Michael Kitt
European Respiratory Journal 2020 56: 4564; DOI: 10.1183/13993003.congress-2020.4564
Yoshihiro Kanemitsu
1The University of Manchester, Manchester, United Kingdom
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  • For correspondence: yoshihiro.kanemitsu@manchester.ac.uk
Jaclyn Smith
1The University of Manchester, Manchester, United Kingdom
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Peter Butera
2Attenua, San Mateo , United States of America
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Brendan Canning
3Johns Hopkins University, Baltimore, United States of America
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Peter Dicpinigaitis
4Albert Einstein College of Medicine, New York, United States of America
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Vivek Iyer
5Mayo Clinic, Rochester, United States of America
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Michael Kitt
2Attenua, San Mateo , United States of America
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Abstract

Background: Several clinical studies have implicated nicotine in reducing cough reflex sensitivity in both healthy smoking and non-smoking subjects. Bradanicline, a highly selective α7 nicotinic acetylcholine receptor (nAChR) agonist, may therefore be effective for refractory chronic cough (RCC), possibly through sensory gating in the central nervous systems.

Rationale: To evaluate the efficacy of bradanicline in RCC patients.

Methods: This randomized, double-blinded, placebo-controlled, crossover study recruited 46 RCC patients (39 females, mean age 63 years, median cough duration 18 years) from November 2018 to February 2019. Patients were allocated to bradanicline-placebo or placebo-bradanicline, 1:1 ratio, after screening for a minimum ≥10 coughs/hr. Following an initial loading dose (50mg bradanicline or matched placebo), study treatment was escalated weekly from 25mg to 75mg, and then 150mg or a matched placebo regimen for a total of 3 weeks of treatment. After a 14-day washout, patients were crossed over. Cough frequency was monitored for 24 hours (VitaloJAK). The primary endpoint was the relationship between bradanicline dose and awake cough frequency (ACF).

Results: All but one patient completed the study and 409/414 cough recordings were available for analysis. Mean ACF at baseline was 36.4 (SD 29.3) coughs/hour. Neither bradanicline nor placebo reduced ACF, with no meaningful difference between the two treatments. Patient reported outcomes also showed no treatment effects. The frequency of adverse effects was similar for bradanicline (n = 16) and placebo (n = 17).

Conclusions: Despite good tolerability, escalating doses of bradanicline did not reduce awake cough frequency in RCC patients compared with placebo.

  • Cough
  • RCT (Randomized Controlled Trial)

Footnotes

Cite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4564.

This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2020
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The Efficacy of Bradanicline in Refractory Chronic Cough
Yoshihiro Kanemitsu, Jaclyn Smith, Peter Butera, Brendan Canning, Peter Dicpinigaitis, Vivek Iyer, Michael Kitt
European Respiratory Journal Sep 2020, 56 (suppl 64) 4564; DOI: 10.1183/13993003.congress-2020.4564

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The Efficacy of Bradanicline in Refractory Chronic Cough
Yoshihiro Kanemitsu, Jaclyn Smith, Peter Butera, Brendan Canning, Peter Dicpinigaitis, Vivek Iyer, Michael Kitt
European Respiratory Journal Sep 2020, 56 (suppl 64) 4564; DOI: 10.1183/13993003.congress-2020.4564
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