Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant

Morice, Alyn H.; Birring, Surinder S.; Smith, Jaclyn A.; McGarvey, Lorcan P.; Schelfhout, Jonathan; Martin Nguyen, Allison; Xu, Zhi Jin; Wu, Wen Chi; Muccino, David R.; Sher, Mandel R.

doi:10.1007/s00408-021-00437-7

Efficacy and safety of pharmacotherapy for refractory or unexplained chronic cough: a systematic review and network meta-analysis (2023)
Journal Article
Zheng, Z., Huang, J., Xiang, Z., Wu, T., Lan, X., Xie, S., …Chen, R. (2023). Efficacy and safety of pharmacotherapy for refractory or unexplained chronic cough: a systematic review and network meta-analysis. EClinicalMedicine, 62, Article 102100. https://doi.org/10.1016/j.eclinm.2023.102100

Background: Refractory chronic cough (RCC) has a significant impact on patient's health-related quality of life and represents a challenge in clinical management. However, the optimal treatment for RCC remains controversial. This study aimed to inves... Read More about Efficacy and safety of pharmacotherapy for refractory or unexplained chronic cough: a systematic review and network meta-analysis.

Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey (2023)
Journal Article
McGarvey, L., Morice, A. H., Martin, A., Li, V. W., Doane, M. J., Urdaneta, E., …Fonseca, E. (2023). Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey. ERJ Open Research, 9(4), Article 00157-2023. https://doi.org/10.1183/23120541.00157-2023

Background Chronic cough, defined as daily cough for at least 8 weeks, negatively affects quality of life and work productivity and increases healthcare resource utilisation. We aimed to determine the prevalence and burden of chronic cough in the UK.... Read More about Burden of chronic cough in the UK: results from the 2018 National Health and Wellness Survey.

Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study (2023)
Journal Article
Dicpinigaitis, P. V., Morice, A. H., Smith, J. A., Sher, M. R., Vaezi, M., Guilleminault, L., …McGarvey, L. (2023). Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study. Lung, 201, Article 255-266. https://doi.org/10.1007/s00408-023-00621-x

Introduction: The PAGANINI study evaluated the efficacy and safety of the selective P2X3 antagonist eliapixant in patients with refractory chronic cough (RCC). Methods: PAGANINI was a randomized, double-blind, parallel-group, placebo-controlled, mult... Read More about Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study.

Improving asthma care through implementation of the SENTINEL programme: findings from the pilot site (2023)
Journal Article
Crooks, M. G., Crowther, L., Cummings, H., Cohen, J., Huang, C., Pitel, L., …Xu, Y. (2023). Improving asthma care through implementation of the SENTINEL programme: findings from the pilot site. ERJ Open Research, 9(3), Article 00685-2022. https://doi.org/10.1183/23120541.00685-2022

Aim: Short-acting β2-agonist (SABA) overuse adversely impacts asthma-related outcomes and the environment. The SABA rEductioN Through ImplemeNting Hull asthma guidELines (SENTINEL) programme aims to reduce SABA overuse through supported implementatio... Read More about Improving asthma care through implementation of the SENTINEL programme: findings from the pilot site.

The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial (2023)
Journal Article
Friedrich, C., Francke, K., Birring, S. S., van den Berg, J. W. K., Marsden, P. A., McGarvey, L., …Morice, A. H. (2023). The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Respiratory Research, 24(1), Article 109. https://doi.org/10.1186/s12931-023-02384-8

BACKGROUND: P2X3 receptor antagonists seem to have a promising potential for treating patients with refractory chronic cough. In this double-blind, randomized, placebo-controlled study, we investigated the efficacy, safety, and tolerability of the no... Read More about The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial.

Antitussive efficacy of the current treatment protocol for refractory chronic cough: our real-world experience in a retrospective cohort study (2023)
Journal Article
Zhang, M., Morice, A. H., Si, F., Zhang, L., Chen, Q., Wang, S., …Qiu, Z. (2023). Antitussive efficacy of the current treatment protocol for refractory chronic cough: our real-world experience in a retrospective cohort study. Therapeutic Advances in Respiratory Disease, 17, https://doi.org/10.1177/17534666231167716

BACKGROUND: The management of refractory chronic cough (RCC) is a great challenge. Neuromodulators have long been used for RCC with imperfect efficacy. OBJECTIVES: We summarized the outcomes of the current treatments used at our specialist cough clin... Read More about Antitussive efficacy of the current treatment protocol for refractory chronic cough: our real-world experience in a retrospective cohort study.

Ingredients of Vicks VapoRub inhibit rhinovirus-induced ATP release (2023)
Journal Article
Stinson, R. J., Morice, A. H., Ahmad, B., & Sadofsky, L. R. (2023). Ingredients of Vicks VapoRub inhibit rhinovirus-induced ATP release. Drugs in Context, 12, 1-18. https://doi.org/10.7573/dic.2023-3-2

Background: Over-the-counter therapies, such as Vicks VapoRub, are frequently used in the management of upper respiratory tract infection symptoms. Of these, acute cough is the most bothersome; however, the mechanisms involved have not been fully elu... Read More about Ingredients of Vicks VapoRub inhibit rhinovirus-induced ATP release.

Nebivolol as a Potent TRPM8 Channel Blocker: A Drug-Screening Approach through Automated Patch Clamping and Ligand-Based Virtual Screening (2022)
Journal Article
Jahanfar, F., Sadofsky, L., Morice, A., & D’Amico, M. (2022). Nebivolol as a Potent TRPM8 Channel Blocker: A Drug-Screening Approach through Automated Patch Clamping and Ligand-Based Virtual Screening. Membranes, 12(10), Article 954. https://doi.org/10.3390/membranes12100954

Transient Receptor Potential Melastatin 8 (TRPM8) from the melastatin TRP channel subfamily is a non-selective Ca2+-permeable ion channel with multimodal gating which can be activated by low temperatures and cooling compounds, such as menthol and ici... Read More about Nebivolol as a Potent TRPM8 Channel Blocker: A Drug-Screening Approach through Automated Patch Clamping and Ligand-Based Virtual Screening.

Investigating the diagnostic utility of high-resolution oesophageal manometry in patients with refractory respiratory symptoms (2022)
Journal Article
Sykes, D. L., Crooks, M. G., Hart, S. P., Jackson, W., Gallagher, J., & Morice, A. H. (2022). Investigating the diagnostic utility of high-resolution oesophageal manometry in patients with refractory respiratory symptoms. Respiratory medicine, 202, Article 106985. https://doi.org/10.1016/j.rmed.2022.106985

Background: The interaction between the respiratory and gastrointestinal systems, and the role of the latter in the development of respiratory pathology, has been examined with a focus on gastro-oesophageal reflux disease (GORD). However, little data... Read More about Investigating the diagnostic utility of high-resolution oesophageal manometry in patients with refractory respiratory symptoms.

Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups (2022)
Journal Article
Smith, J. A., Birring, S. S., Dicpinigaitis, P. V., McGarvey, L. P., Morice, A. H., Pavord, I. D., …Muccino, D. (2022). Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups. Lung, 200(4), 423-429. https://doi.org/10.1007/s00408-022-00553-y

Introduction: In phase 3 trials (COUGH-1/COUGH-2), gefapixant 45 mg twice daily significantly reduced 24-h cough frequency vs placebo in refractory or unexplained chronic cough (RCC or UCC). Methods: Here, the efficacy of gefapixant 45 mg vs placebo... Read More about Improvements in Objective and Subjective Measures of Chronic Cough with Gefapixant: A Pooled Phase 3 Efficacy Analysis of Predefined Subgroups.

Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study (2022)
Journal Article
Friedrich, C., Francke, K., Gashaw, I., Scheerans, C., Klein, S., Fels, L., …Morice, A. (2022). Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. Clinical Pharmacokinetics, 61, 1143–1156. https://doi.org/10.1007/s40262-022-01126-1

Background and Objective: There is no licensed treatment for refractory chronic cough; off-label therapies have limited efficacy and can produce adverse effects. Excessive adenosine triphosphate signaling via P2X3 receptors is implicated in refractor... Read More about Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study.

Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough (2022)
Journal Article
Dicpinigaitis, P. V., Birring, S. S., Blaiss, M., McGarvey, L. P., Morice, A. H., Pavord, I. D., …Muccino, D. (2023). Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough. Annals of Allergy, Asthma and Immunology, 130(1), 60-66. https://doi.org/10.1016/j.anai.2022.05.003

Background: The current characterization of patients with refractory or unexplained chronic cough (RCC and UCC, respectively) primarily stems from relatively small clinical studies. Objective: To report the baseline medical history and clinical chara... Read More about Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough.

Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS) (2022)
Journal Article
Cotton, S., Devereux, G., Abbas, H., Briggs, A., Campbell, K., Chaudhuri, R., …Lipworth, B. J. (2022). Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS). Trials, 23(1), Article 307. https://doi.org/10.1186/s13063-022-06226-8

Background: Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity, mortality and healthcare costs. Beta blockers are well-established drugs widely used to treat cardiovascular conditions. Observational studies consiste... Read More about Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS).

Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials (2022)
Journal Article
McGarvey, L. P., Birring, S. S., Morice, A. H., Dicpinigaitis, P. V., Pavord, I. D., Schelfhout, J., …Smith, J. A. (2022). Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials. Lancet, 399(10328), 909-923. https://doi.org/10.1016/S0140-6736%2821%2902348-5

Background: Gefapixant is an oral P2X3 receptor antagonist that has previously shown efficacy and safety in refractory chronic cough and unexplained chronic cough. We therefore aim to confirm the efficacy and safety of gefapixant in participants with... Read More about Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough (2022)
Journal Article
McGarvey, L., Smith, J. A., Morice, A., Birring, S. S., Chung, K. F., Dicpinigaitis, P. V., …Gomez, J. C. (2022). A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough. Lung, https://doi.org/10.1007/s00408-022-00592-5

Introduction: To determine the optimal dose of sivopixant, a highly selective P2X3 receptor antagonist, for refractory or unexplained chronic cough (RCC/UCC). Methods: In this phase 2b, randomized, double-blind, placebo-controlled, parallel-group, mu... Read More about A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough.

Adaptive study design to assess effect of TRPV4 inhibition in patients with chronic cough (2021)
Journal Article
Ludbrook, V. J., Hanrott, K. E., Kreindler, J. L., Marks-Konczalik, J. E., Bird, N. P., Hewens, D. A., …Smith, J. (2021). Adaptive study design to assess effect of TRPV4 inhibition in patients with chronic cough. ERJ Open Research, 7(3), Article 00269-2021. https://doi.org/10.1183/23120541.00269-2021

Objective Airway sensory nerves involved in the cough reflex are activated by adenosine triphosphate (ATP) agonism of P2X purinoceptor 3 (P2X3) receptors. Transient receptor potential vanilloid 4 (TRPV4) channel activation causes ATP release from air... Read More about Adaptive study design to assess effect of TRPV4 inhibition in patients with chronic cough.

Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: A randomised, placebo-controlled, crossover phase 2a study (2021)
Journal Article
Morice, A., Smith, J. A., McGarvey, L., Birring, S. S., Parker, S. M., Turner, A., …Friedrich, C. (2021). Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: A randomised, placebo-controlled, crossover phase 2a study. European respiratory journal, 58(5), Article 2004240. https://doi.org/10.1183/13993003.04240-2020

Background. 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 a... Read More about Eliapixant (BAY 1817080), a P2X3 receptor antagonist, in refractory chronic cough: A randomised, placebo-controlled, crossover phase 2a study.

Domiciliary Cough Monitoring for the Prediction of COPD Exacerbations (2021)
Journal Article
Crooks, M. G., den Brinker, A. C., Thackray-Nocera, S., van Dinther, R., Wright, C. E., & Morice, A. H. (2021). Domiciliary Cough Monitoring for the Prediction of COPD Exacerbations. Lung, 199(2), 131-137. https://doi.org/10.1007/s00408-021-00435-9

Introduction: Acute exacerbations of COPD (AE-COPD) are a leading cause of health service utilisation and are associated with morbidity and mortality. Identifying the prodrome of AE-COPD by monitoring symptoms and physiological parameters (telemonito... Read More about Domiciliary Cough Monitoring for the Prediction of COPD Exacerbations.

Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant (2021)
Journal Article
Morice, A. H., Birring, S. S., Smith, J. A., McGarvey, L. P., Schelfhout, J., Martin Nguyen, A., …Sher, M. R. (2021). Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant. Lung, 199(2), 121-129. https://doi.org/10.1007/s00408-021-00437-7

Purpose: This analysis assesses clinical characteristics of patients with refractory chronic cough (RCC) or unexplained chronic cough (UCC) enrolled in a phase 2 study to better understand this patient population. Methods: Patients with RCC/UCC lasti... Read More about Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant.

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