Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study

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Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough : a randomised, placebo-controlled, crossover phase 2a study. / Morice, Alyn ; Smith, Jaclyn A ; McGarvey, Lorcan ; Birring, Surinder S ; Parker, Sean M ; Turner, Alice; Hummel, Thomas; Gashaw, Isabella ; Fels, Lueder ; Klein, Stefan ; Francke, Klaus ; Friedrich, Christian .

In: The European respiratory journal, Vol. 57, No. 5, 2004240, 13.05.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

Morice, A, Smith, JA, McGarvey, L, Birring, SS, Parker, SM, Turner, A, Hummel, T, Gashaw, I, Fels, L, Klein, S, Francke, K & Friedrich, C 2021, 'Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study', The European respiratory journal, vol. 57, no. 5, 2004240. https://doi.org/10.1183/13993003.04240-2020

APA

Morice, A., Smith, J. A., McGarvey, L., Birring, S. S., Parker, S. M., Turner, A., Hummel, T., Gashaw, I., Fels, L., Klein, S., Francke, K., & Friedrich, C. (2021). Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study. The European respiratory journal, 57(5), [2004240]. https://doi.org/10.1183/13993003.04240-2020

Vancouver

Author

Morice, Alyn ; Smith, Jaclyn A ; McGarvey, Lorcan ; Birring, Surinder S ; Parker, Sean M ; Turner, Alice ; Hummel, Thomas ; Gashaw, Isabella ; Fels, Lueder ; Klein, Stefan ; Francke, Klaus ; Friedrich, Christian . / Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough : a randomised, placebo-controlled, crossover phase 2a study. In: The European respiratory journal. 2021 ; Vol. 57, No. 5.

Bibtex

@article{ca245b5c117944f88e77f1412902c6ff,
title = "Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: a randomised, placebo-controlled, crossover phase 2a study",
abstract = "ATP acting via P2X3 receptors is an important mediator of refractory chronic cough (RCC). This phase 2a double-blinded crossover study assessed the safety, tolerability and efficacy of eliapixant (BAY 1817080), a selective P2X3 receptor antagonist, in adults with RCC attending specialist centres.In period A, patients received placebo for 2 weeks then eliapixant 10 mg for 1 week. In period B, patients received eliapixant 50, 200 and 750 mg twice daily for 1 week per dose level. Patients were randomised 1:1 to period A–B (n=20) or B–A (n=20). The primary efficacy endpoint was change in cough frequency assessed over 24 h (VitaloJAK). Primary safety endpoint was frequency and severity of adverse events (AEs).Thirty-seven patients completed randomised therapy. Mean cough frequency fell by 17.4% versus baseline with placebo. Eliapixant reduced cough frequency at doses ≥50 mg (reduction versus placebo at 750 mg, 25%: 90% confidence interval, 11.5–36.5%; p=0.002). Doses ≥50 mg also significantly reduced cough severity. AEs, mostly mild or moderate, were reported in 65% of patients with placebo and 41–49% receiving eliapixant. Cumulative rates of taste-related AEs were 3% with placebo and 5–21% with eliapixant: all were mild.Selective P2X3 antagonism with eliapixant significantly reduced cough frequency and severity, confirming this as a viable therapeutic pathway for RCC. Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant. Selective P2X3 antagonism appears to be a novel therapeutic approach for RCC",
author = "Alyn Morice and Smith, {Jaclyn A} and Lorcan McGarvey and Birring, {Surinder S} and Parker, {Sean M} and Alice Turner and Thomas Hummel and Isabella Gashaw and Lueder Fels and Stefan Klein and Klaus Francke and Christian Friedrich",
year = "2021",
month = may,
day = "13",
doi = "10.1183/13993003.04240-2020",
language = "English",
volume = "57",
journal = "The European respiratory journal",
issn = "0903-1936",
publisher = "European Respiratory Society",
number = "5",

}

RIS

TY - JOUR

T1 - Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough

T2 - a randomised, placebo-controlled, crossover phase 2a study

AU - Morice, Alyn

AU - Smith, Jaclyn A

AU - McGarvey, Lorcan

AU - Birring, Surinder S

AU - Parker, Sean M

AU - Turner, Alice

AU - Hummel, Thomas

AU - Gashaw, Isabella

AU - Fels, Lueder

AU - Klein, Stefan

AU - Francke, Klaus

AU - Friedrich, Christian

PY - 2021/5/13

Y1 - 2021/5/13

N2 - ATP acting via P2X3 receptors is an important mediator of refractory chronic cough (RCC). This phase 2a double-blinded crossover study assessed the safety, tolerability and efficacy of eliapixant (BAY 1817080), a selective P2X3 receptor antagonist, in adults with RCC attending specialist centres.In period A, patients received placebo for 2 weeks then eliapixant 10 mg for 1 week. In period B, patients received eliapixant 50, 200 and 750 mg twice daily for 1 week per dose level. Patients were randomised 1:1 to period A–B (n=20) or B–A (n=20). The primary efficacy endpoint was change in cough frequency assessed over 24 h (VitaloJAK). Primary safety endpoint was frequency and severity of adverse events (AEs).Thirty-seven patients completed randomised therapy. Mean cough frequency fell by 17.4% versus baseline with placebo. Eliapixant reduced cough frequency at doses ≥50 mg (reduction versus placebo at 750 mg, 25%: 90% confidence interval, 11.5–36.5%; p=0.002). Doses ≥50 mg also significantly reduced cough severity. AEs, mostly mild or moderate, were reported in 65% of patients with placebo and 41–49% receiving eliapixant. Cumulative rates of taste-related AEs were 3% with placebo and 5–21% with eliapixant: all were mild.Selective P2X3 antagonism with eliapixant significantly reduced cough frequency and severity, confirming this as a viable therapeutic pathway for RCC. Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant. Selective P2X3 antagonism appears to be a novel therapeutic approach for RCC

AB - ATP acting via P2X3 receptors is an important mediator of refractory chronic cough (RCC). This phase 2a double-blinded crossover study assessed the safety, tolerability and efficacy of eliapixant (BAY 1817080), a selective P2X3 receptor antagonist, in adults with RCC attending specialist centres.In period A, patients received placebo for 2 weeks then eliapixant 10 mg for 1 week. In period B, patients received eliapixant 50, 200 and 750 mg twice daily for 1 week per dose level. Patients were randomised 1:1 to period A–B (n=20) or B–A (n=20). The primary efficacy endpoint was change in cough frequency assessed over 24 h (VitaloJAK). Primary safety endpoint was frequency and severity of adverse events (AEs).Thirty-seven patients completed randomised therapy. Mean cough frequency fell by 17.4% versus baseline with placebo. Eliapixant reduced cough frequency at doses ≥50 mg (reduction versus placebo at 750 mg, 25%: 90% confidence interval, 11.5–36.5%; p=0.002). Doses ≥50 mg also significantly reduced cough severity. AEs, mostly mild or moderate, were reported in 65% of patients with placebo and 41–49% receiving eliapixant. Cumulative rates of taste-related AEs were 3% with placebo and 5–21% with eliapixant: all were mild.Selective P2X3 antagonism with eliapixant significantly reduced cough frequency and severity, confirming this as a viable therapeutic pathway for RCC. Taste-related side-effects were lower at therapeutic doses than with the less selective P2X3 antagonist gefapixant. Selective P2X3 antagonism appears to be a novel therapeutic approach for RCC

UR - http://erj.ersjournals.com/

U2 - 10.1183/13993003.04240-2020

DO - 10.1183/13993003.04240-2020

M3 - Article

VL - 57

JO - The European respiratory journal

JF - The European respiratory journal

SN - 0903-1936

IS - 5

M1 - 2004240

ER -