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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05813223
Registration number
NCT05813223
Ethics application status
Date submitted
20/03/2023
Date registered
14/04/2023
Titles & IDs
Public title
Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
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Scientific title
The Effect of Acute and Prolonged Administration of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
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Secondary ID [1]
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0
2023.005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Cough
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Condition category
Condition code
Respiratory
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0
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gefapixant
Experimental: Gefapixant treatment - Participants will asked to take an oral tablet containing 45mg Gefapixant twice daily (BID).
Treatment: Drugs: Gefapixant
Purinergic (P2X3) Receptor antagonist. Film-coated tablet taken orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in cough-related brain activity using brain imaging following Gefapixant administration
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Assessment method [1]
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We will investigate the time-dependent effect of Gefapixant treatment on brain activity evoked by inhaled ATP and capsaicin as measured using functional Magnetic Resonance Imaging (fMRI). The principle endpoint is measured as the change in capsaicin and ATP evoked Blood Oxygen Level Dependent (BOLD) signal and the unit of measure is percentage.
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Timepoint [1]
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Gefapixant administration will be for 12 weeks with brain scans to be performed before, 3 days after, and 12 weeks after dosing.
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Primary outcome [2]
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Change in cough-related brain activity using brain imaging following Gefapixant withdrawal
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Assessment method [2]
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We will follow up with participants 1 week after stopping Gefapixant dosing and investigate the time-dependent effect of Gefapixant treatment on brain activity evoked by inhaled ATP and capsaicin as measured using functional Magnetic Resonance Imaging (fMRI). The principle endpoint is measured as the change in capsaicin and ATP evoked Blood Oxygen Level Dependent (BOLD) signal and the unit of measure is percentage.
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Timepoint [2]
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Brain imaging will be performed 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [1]
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Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant administration
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Assessment method [1]
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We will investigate participant's cough sensitivity thresholds by inhaled cough challenge testing. This involves participants inhaling single breaths of increasing concentrations of tussigenic stimuli (capsaicin and ATP) as well as saline control to determine threshold doses that elicit an urge to cough, two coughs (C2) and five coughs (C5). The principle endpoint is measured as the change in capsaicin and ATP concentration needed to elicit cough responses and the unit of measure is micromolar.
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Timepoint [1]
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Cough thresholds will be determined before, 3 days after and 12 weeks after Gefapixant dosing.
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Secondary outcome [2]
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Change in Urge To Cough Visual Analogue Scale (UTCVAS) score after Gefapixant administration
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Assessment method [2]
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Participants will be asked to self-report on their urge to cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No urge to cough" and a maximum value of 100 labelled "Worst urge to cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in UTCVAS score and the unit of measure is points.
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Timepoint [2]
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Participant self-reports using the UTCVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
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Secondary outcome [3]
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Change in Cough Visual Analogue Scale (CVAS) score after Gefapixant administration
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Assessment method [3]
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Participants will be asked to self-report on their cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No cough" and a maximum value of 100 labelled "Worst cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in CVAS score and the unit of measure is points.
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Timepoint [3]
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Participant self-reports using the CVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
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Secondary outcome [4]
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Change in Leicester Cough Questionnaire (LCQ) score after Gefapixant administration
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Assessment method [4]
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Participants will be asked to self-report on the impact of cough on their quality of life. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to the impact of cough in one of three domains (physical, psychological social). The LCQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in LCQ score and the unit of measure is points.
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Timepoint [4]
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Participant self-reports using the LCQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
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Secondary outcome [5]
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Change in Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score after Gefapixant administration
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Assessment method [5]
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Participants will be asked to self-report on sensations related to laryngeal hypersensitivity. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to an upper airway sensation in one of three domains (throat obstruction, throat pain/thermal), throat tickle). The NHLQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in NLHQ score and the unit of measure is points.
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Timepoint [5]
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Participant self-reports using the NLHQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
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Secondary outcome [6]
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Change in Hull Airway Reflux Questionnaire (HARQ) score after Gefapixant administration
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Assessment method [6]
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Participants will be asked to self-report on symptoms related to airway reflux. Each item requires a rating on a 6-point Likert scale from 0 to 5 and is related to an aspect of airway reflux. The HARQ is scored by adding the total ratings (range 0-70). A higher score indicates a worse outcome. The principal endpoint is measured as the change in HARQ score and the unit of measure is points.
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Timepoint [6]
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Participant self-reports using the HARQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
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Secondary outcome [7]
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Change in Cough Severity Diary (CSD) score after Gefapixant administration
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Assessment method [7]
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Participants will be asked to self-report on their daily cough severity. Each item requires a rating on an 11-point Likert scale from 0 to 10 and is related to an aspect of cough in one of three domains (frequency, intensity, disruption). The CSD is scored by averaging the ratings in each domain, as well as averaging across all items (range 1-10). A higher score indicates a worse outcome. The principal endpoint is measured as the change in CSD score and the unit of measure is points.
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Timepoint [7]
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Participant self-reports using the CSD will be collected every day for 12 weeks after the start of Gefapixant administration.
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Secondary outcome [8]
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Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant withdrawal
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Assessment method [8]
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We will follow up with participants 1 week after stopping Gefapixant dosing and investigate participant's cough sensitivity thresholds by inhaled cough challenge testing. This involves participants inhaling single breaths of increasing concentrations of tussigenic stimuli (capsaicin and ATP) as well as saline control to determine threshold doses that elicit an urge to cough, two coughs (C2) and five coughs (C5). The principle endpoint is measured as the change in capsaicin and ATP concentration needed to elicit cough responses and the unit of measure is micromolar.
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Timepoint [8]
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Cough thresholds will be determined 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [9]
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Change in Urge To Cough Visual Analogue Scale (UTCVAS) score following Gefapixant withdrawal
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Assessment method [9]
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We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on their urge to cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No urge to cough" and a maximum value of 100 labelled "Worst urge to cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in UTCVAS score and the unit of measure is points.
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Timepoint [9]
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Participant self-report using the UTCVAS will be collected 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [10]
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Change in Cough Visual Analogue Scale (CVAS) score following Gefapixant withdrawal
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Assessment method [10]
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We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on their cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No cough" and a maximum value of 100 labelled "Worst cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in CVAS score and the unit of measure is points.
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Timepoint [10]
0
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Participant self-report using the CVAS will be collected 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [11]
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Change in Leicester Cough Questionnaire (LCQ) score following Gefapixant withdrawal
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Assessment method [11]
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We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on the impact of cough on their quality of life. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to the impact of cough in one of three domains (physical, psychological social). The LCQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in LCQ score and the unit of measure is points.
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Timepoint [11]
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Participant self-report using the LCQ will be collected 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [12]
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Change in Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score following Gefapixant withdrawal
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Assessment method [12]
0
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We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on sensations related to laryngeal hypersensitivity. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to an upper airway sensation in one of three domains (throat obstruction, throat pain/thermal), throat tickle). The NHLQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in NLHQ score and the unit of measure is points.
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Timepoint [12]
0
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Participant self-report using the NHLQ will be collected 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [13]
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Change in Hull Airway Reflux Questionnaire (HARQ) score following Gefapixant withdrawal
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Assessment method [13]
0
0
We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on symptoms related to airway reflux. Each item requires a rating on a 6-point Likert scale from 0 to 5 and is related to an aspect of airway reflux. The HARQ is scored by adding the total ratings (range 0-70). A higher score indicates a worse outcome. The principal endpoint is measured as the change in HARQ score and the unit of measure is points.
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Timepoint [13]
0
0
Participant self-report using the HARQ will be collected 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [14]
0
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Change in Cough Severity Diary (CSD) score following Gefapixant withdrawal
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Assessment method [14]
0
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We will follow up with participants 1 week after stopping Gefapixant dosing. Participants will be asked to self-report on their daily cough severity. Each item requires a rating on an 11-point Likert scale from 0 to 10 and is related to an aspect of cough in one of three domains (frequency, intensity, disruption). The CSD is scored by averaging the ratings in each domain, as well as averaging across all items (range 1-10). A higher score indicates a worse outcome. The principal endpoint is measured as the change in CSD score and the unit of measure is points.
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Timepoint [14]
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Participant self-report using the CSD will be collected every day in the 1 week after Gefapixant withdrawal (Week 13).
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Secondary outcome [15]
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Sustainability of Gefapixant treatment effects on cough challenge sensitivity.
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Assessment method [15]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. We will investigate participant's cough sensitivity thresholds by inhaled cough challenge testing. This involves participants inhaling single breaths of increasing concentrations of tussigenic stimuli (capsaicin and ATP) as well as saline control to determine threshold doses that elicit an urge to cough, two coughs (C2) and five coughs (C5). The principle endpoint is measured as the change in capsaicin and ATP concentration needed to elicit cough responses and the unit of measure is micromolar.
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Timepoint [15]
0
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Cough thresholds will be determined at 6 and 12 months (relative to start of study).
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Secondary outcome [16]
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Sustainability of Gefapixant treatment effects on Urge To Cough Visual Analogue Scale (UTCVAS) score
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Assessment method [16]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on their urge to cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No urge to cough" and a maximum value of 100 labelled "Worst urge to cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in UTCVAS score and the unit of measure is points.
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Timepoint [16]
0
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Participant self-report using the UTCVAS will be collected at 6 and 12 months (relative to start of study).
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Secondary outcome [17]
0
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Sustainability of Gefapixant treatment effects on Cough Visual Analogue Scale (CVAS) score
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Assessment method [17]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on their cough severity using the Urge to Cough Visual Analogue Scale. The scale is 100 units with a minimum value of 0 labelled "No cough" and a maximum value of 100 labelled "Worst cough ever". A higher score indicates a worse outcome. The principal endpoint is measured as the change in CVAS score and the unit of measure is points.
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Timepoint [17]
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Participant self-report using the CVAS will be collected at 6 and 12 months (relative to start of study).
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Secondary outcome [18]
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Sustainability of Gefapixant treatment effects on Leicester Cough Questionnaire (LCQ) score
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Assessment method [18]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on the impact of cough on their quality of life. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to the impact of cough in one of three domains (physical, psychological social). The LCQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in LCQ score and the unit of measure is points.
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Timepoint [18]
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Participant self-report using the LCQ will be collected at 6 and 12 months (relative to start of study).
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Secondary outcome [19]
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Sustainability of Gefapixant treatment effects on Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score
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Assessment method [19]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on sensations related to laryngeal hypersensitivity. Each item requires a rating on a 7-point Likert scale from 1 to 7 and is related to an upper airway sensation in one of three domains (throat obstruction, throat pain/thermal), throat tickle). The NHLQ is scored by averaging the ratings in each domain and then adding the average domain scores (range 3-21). A higher score indicates a better outcome. The principal endpoint is measured as the change in NLHQ score and the unit of measure is points.
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Timepoint [19]
0
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Participant self-report using the NLHQ will be collected at 6 and 12 months (relative to start of study).
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Secondary outcome [20]
0
0
Sustainability of Gefapixant treatment effects on Hull Airway Reflux Questionnaire (HARQ) score
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Assessment method [20]
0
0
Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on symptoms related to airway reflux. Each item requires a rating on a 6-point Likert scale from 0 to 5 and is related to an aspect of airway reflux. The HARQ is scored by adding the total ratings (range 0-70). A higher score indicates a worse outcome. The principal endpoint is measured as the change in HARQ score and the unit of measure is points.
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Timepoint [20]
0
0
Participant self-report using the HARQ will be collected at 6 and 12 months (relative to start of study).
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Secondary outcome [21]
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0
Sustainability of Gefapixant treatment effects on Cough Severity Diary (CSD) score
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Assessment method [21]
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Participants can opt to resume Gefapixant administration for another 9 months after completion of the withdrawal assessments. Participants will be asked to self-report on their daily cough severity. Each item requires a rating on an 11-point Likert scale from 0 to 10 and is related to an aspect of cough in one of three domains (frequency, intensity, disruption). The CSD is scored by averaging the ratings in each domain, as well as averaging across all items (range 1-10). A higher score indicates a worse outcome. The principal endpoint is measured as the change in CSD score and the unit of measure is points.
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Timepoint [21]
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Participant self-report using the CSD will be collected every day from Week 14 until 12 months (relative to start of study).
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Eligibility
Key inclusion criteria
* Written informed consent to participate in the study. 18-65 years old; Male or female.
* Non-smokers for at least 5 years and have no history of neurological disease or any recent history (over 8 weeks) of acute respiratory infections.
* Presence of Refractory Chronic Cough (RCC) or Unexplained Chronic Cough (UCC) for =1 year, defined as cough unresponsive to treatment for underlying conditions including reflux disease, asthma and rhinitis.
* Presence of cough symptoms as determined by a self-reported cough severity of =40mm on 10-point scale on screening.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current smokers or recreational drug users.
* Women who are pregnant.
* People with contraindications to MRI scanning (i.e. metal implants, claustrophobia).
* Children and/or young people (ie. <18 years).
* People with an intellectual or mental impairment.
* People highly dependent on medical care.
* People in existing dependent or unequal relationships with any member of the research team.
* People with known allergy to chili (very rare).
* Non-English speakers (as English proficiency is required to accurately complete research tasks).
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 0
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
31
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
The University of Melbourne - Parkville
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Recruitment postcode(s) [1]
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0
3010 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Stuart Mazzone
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Merck Sharp & Dohme LLC
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Address [1]
0
0
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0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
0
Melbourne Health
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Address [2]
0
0
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0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
0
0
Monash University
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Address [3]
0
0
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Country [3]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
Recently, a new drug called Gefapixant passed phase III clinical trials for cough suppression in patients with chronic cough. The goal of this clinical trial is to investigate the effect of acute and prolonged administration of the drug Gefapixant on cough-related brain activity in patients with chronic cough. The main question it aims to answer is: does the mechanism of action of Gefapixant on the brainstem and brain circuits regulating cough differ between acute and prolonged therapy in people with chronic cough? Participants have their brain activity and their sensitivity to cough-inducing substances measured as well as complete questionnaires about their cough before and while taking daily Gefapixant.
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Trial website
https://clinicaltrials.gov/study/NCT05813223
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Trial related presentations / publications
Chung KF, Pavord ID. Prevalence, pathogenesis, and causes of chronic cough. Lancet. 2008 Apr 19;371(9621):1364-74. doi: 10.1016/S0140-6736(08)60595-4. Chung KF, McGarvey L, Mazzone SB. Chronic cough as a neuropathic disorder. Lancet Respir Med. 2013 Jul;1(5):414-22. doi: 10.1016/S2213-2600(13)70043-2. Epub 2013 May 3. Mazzone SB, McLennan L, McGovern AE, Egan GF, Farrell MJ. Representation of capsaicin-evoked urge-to-cough in the human brain using functional magnetic resonance imaging. Am J Respir Crit Care Med. 2007 Aug 15;176(4):327-32. doi: 10.1164/rccm.200612-1856OC. Epub 2007 Jun 15. Ando A, Smallwood D, McMahon M, Irving L, Mazzone SB, Farrell MJ. Neural correlates of cough hypersensitivity in humans: evidence for central sensitisation and dysfunctional inhibitory control. Thorax. 2016 Apr;71(4):323-9. doi: 10.1136/thoraxjnl-2015-207425. Epub 2016 Feb 9. Thomas D, Gibson PG. Gefapixant for chronic cough. Lancet. 2022 Mar 5;399(10328):886-887. doi: 10.1016/S0140-6736(21)02438-7. No abstract available. McGarvey LP, Birring SS, Morice AH, Dicpinigaitis PV, Pavord ID, Schelfhout J, Nguyen AM, Li Q, Tzontcheva A, Iskold B, Green SA, Rosa C, Muccino DR, Smith JA; COUGH-1 and COUGH-2 Investigators. 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. 2022 Mar 5;399(10328):909-923. doi: 10.1016/S0140-6736(21)02348-5. Smith JA, Kitt MM, Morice AH, Birring SS, McGarvey LP, Sher MR, Li YP, Wu WC, Xu ZJ, Muccino DR, Ford AP; Protocol 012 Investigators. Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial. Lancet Respir Med. 2020 Aug;8(8):775-785. doi: 10.1016/S2213-2600(19)30471-0. Epub 2020 Feb 25. Morice AH, Jakes AD, Faruqi S, Birring SS, McGarvey L, Canning B, Smith JA, Parker SM, Chung KF, Lai K, Pavord ID, van den Berg J, Song WJ, Millqvist E, Farrell MJ, Mazzone SB, Dicpinigaitis P; Chronic Cough Registry. A worldwide survey of chronic cough: a manifestation of enhanced somatosensory response. Eur Respir J. 2014 Nov;44(5):1149-55. doi: 10.1183/09031936.00217813. Epub 2014 Sep 3. Morice AH, Kitt MM, Ford AP, Tershakovec AM, Wu WC, Brindle K, Thompson R, Thackray-Nocera S, Wright C. The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: a randomised placebo-controlled study. Eur Respir J. 2019 Jul 4;54(1):1900439. doi: 10.1183/13993003.00439-2019. Print 2019 Jul. Dicpinigaitis PV, Alva RV. Safety of capsaicin cough challenge testing. Chest. 2005 Jul;128(1):196-202. doi: 10.1378/chest.128.1.196.
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Public notes
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Contacts
Principal investigator
Name
0
0
Stuart B Mazzone, PhD
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Address
0
0
+61383446457
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Stuart B Mazzone, PhD
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Address
0
0
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Country
0
0
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Phone
0
0
+61383446457
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05813223