Transient receptor potential vanilloid 1 (TRPV1) antagonism in patients with refractory chronic cough: A double-blind randomized controlled trial
Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agen...
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| Published in | Journal of allergy and clinical immunology Vol. 134; no. 1; pp. 56 - 62.e4 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Elsevier Inc
01.07.2014
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents.
We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough.
Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected.
Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498.
This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. |
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| AbstractList | Background Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents. Objective We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough. Methods Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected. Results Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498. Conclusion This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents. We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough. Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected. Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498. This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. Background Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents. Objective We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough. Methods Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected. Results Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498. Conclusion This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents.BACKGROUNDInhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents.We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough.OBJECTIVEWe sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough.Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected.METHODSTwenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected.Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498.RESULTSTreatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2; P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5; P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498.This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents.CONCLUSIONThis study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. Background Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor potential vanilloid 1 (TRPV1) on airway sensory nerves. Therefore the TRPV1 receptor is an attractive target for the development of antitussive agents. Objective We sought to assess the antitussive effect of TRPV1 antagonism in patients with refractory chronic cough. Methods Twenty-one subjects with refractory chronic cough (>8 weeks) attending a specialist clinic were recruited to a randomized, double-blind, placebo-controlled crossover trial assessing a TRPV1 antagonist (SB-705498). Cough reflex sensitivity to capsaicin (concentration of capsaicin inducing at least 5 coughs) and 24-hour cough frequency were coprimary end points assessed after a single dose of SB-705498 (600 mg) and matched placebo. Cough severity and urge to cough were reported on visual analog scales, and cough-specific quality of life data were also collected. Results Treatment with SB-705498 produced a significant improvement in cough reflex sensitivity to capsaicin at 2 hours and a borderline significant improvement at 24 hours compared with placebo (adjusted mean difference of +1.3 doubling doses at 2 hours [95% CI, +0.3 to +2.2;P = .0049] and +0.7 doubling doses at 24 hours [95% CI, +0.0 to +1.5;P = .0259]). However, 24-hour objective cough frequency was not improved compared with placebo. Patient-reported cough severity, urge to cough, and cough-specific quality of life similarly suggested no effect of SB-705498. Conclusion This study raises important questions about both the role of TRVP1-mediated mechanisms in patients with refractory chronic cough and also the predictive value of capsaicin challenge testing in the assessment of novel antitussive agents. |
| Author | Dockry, Rachel Newlands, Amy Kelsall, Angela Khalid, Saifudin Smart, Kevin Woodcock, Ashley Murdoch, Robert Holt, Kimberley Smith, Jaclyn A. |
| Author_xml | – sequence: 1 givenname: Saifudin surname: Khalid fullname: Khalid, Saifudin organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom – sequence: 2 givenname: Robert surname: Murdoch fullname: Murdoch, Robert organization: GlaxoSmithKline, Stevenage, United Kingdom – sequence: 3 givenname: Amy surname: Newlands fullname: Newlands, Amy organization: GlaxoSmithKline, Stevenage, United Kingdom – sequence: 4 givenname: Kevin surname: Smart fullname: Smart, Kevin organization: GlaxoSmithKline, Stevenage, United Kingdom – sequence: 5 givenname: Angela surname: Kelsall fullname: Kelsall, Angela organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom – sequence: 6 givenname: Kimberley surname: Holt fullname: Holt, Kimberley organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom – sequence: 7 givenname: Rachel surname: Dockry fullname: Dockry, Rachel organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom – sequence: 8 givenname: Ashley surname: Woodcock fullname: Woodcock, Ashley organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom – sequence: 9 givenname: Jaclyn A. surname: Smith fullname: Smith, Jaclyn A. email: jacky.smith@manchester.ac.uk organization: Centre for Respiratory and Allergy, University of Manchester, University Hospital of South Manchester, Manchester, United Kingdom |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28610803$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/24666696$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2014 American Academy of Allergy, Asthma & Immunology American Academy of Allergy, Asthma & Immunology 2015 INIST-CNRS Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved. Copyright Elsevier Limited Jul 2014 |
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| Keywords | transient receptor potential vanilloid 1 VAS HRT IQR TRPV1 CQLQ Cough sensory nerves C2 C5 capsaicin Tmax cough sounds Concentration of capsaicin inducing at least 5 coughs Time to maximum observed plasma concentration Visual analog scale Interquartile range T max Concentration of capsaicin inducing at least 2 coughs Hormone replacement therapy Cough Quality of Life Questionnaire Human Immunopathology Treatment resistance Capsaicin Randomized controlled trial Transitory Antagonism Chronic Immunology Double blind study Sensory nerve Biological receptor |
| Language | English |
| License | https://www.elsevier.com/tdm/userlicense/1.0 CC BY 4.0 Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved. |
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| PublicationTitle | Journal of allergy and clinical immunology |
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| Snippet | Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient receptor... Background Inhalation of capsaicin, the extract of hot chili peppers, induces coughing in both animals and human subjects through activation of transient... |
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| SubjectTerms | Administration, Inhalation Adult Aged Allergy and Immunology Animals Antitussive Agents - therapeutic use Biological and medical sciences Capsaicin Chronic Disease Cough Cough - chemically induced Cough - drug therapy Cough - genetics Cough - physiopathology cough sounds Cross-Over Studies Double-Blind Method Drug therapy Female Fundamental and applied biological sciences. Psychology Fundamental immunology Gene Expression Humans Immunopathology Male Medical sciences Middle Aged Plasma Pneumology Pyrrolidines - therapeutic use Quality of Life Respiratory system : syndromes and miscellaneous diseases Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis sensory nerves Severity of Illness Index Studies transient receptor potential vanilloid 1 Treatment Outcome TRPV Cation Channels - antagonists & inhibitors TRPV Cation Channels - genetics Urea - analogs & derivatives Urea - therapeutic use |
| Title | Transient receptor potential vanilloid 1 (TRPV1) antagonism in patients with refractory chronic cough: A double-blind randomized controlled trial |
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