Trial · NCT05813223
Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
NCT05813223, Early phase 1, Unknown, Stuart Mazzone
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough. Trials, record NCT05813223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05813223
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
- NCT number
- NCT05813223
- Status
- Unknown
- Phases
- Early phase 1
- Enrollment
- 31 participants, estimated
- Lead sponsor
- Stuart Mazzone
- Conditions
- Chronic Cough
- Interventions
- Gefapixant
- First posted
- 2023-04-14
- Last updated
- 2024-05-09
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in cough-related brain activity using brain imaging following Gefapixant administration | Gefapixant administration will be for 12 weeks with brain scans to be performed before, 3 days after, and 12 weeks after dosing. | 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. |
| Primary | Change in cough-related brain activity using brain imaging following Gefapixant withdrawal | Brain imaging will be performed 1 week after Gefapixant withdrawal (Week 13). | 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. |
| Secondary | Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant administration | Cough thresholds will be determined before, 3 days after and 12 weeks after Gefapixant dosing. | 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. |
| Secondary | Change in Urge To Cough Visual Analogue Scale (UTCVAS) score after Gefapixant administration | Participant self-reports using the UTCVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after 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. |
| Secondary | Change in Cough Visual Analogue Scale (CVAS) score after Gefapixant administration | Participant self-reports using the CVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after 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. |
| Secondary | Change in Leicester Cough Questionnaire (LCQ) score after Gefapixant administration | Participant self-reports using the LCQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after 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. |
| Secondary | Change in Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score after Gefapixant administration | Participant self-reports using the NLHQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after 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. |
| Secondary | Change in Hull Airway Reflux Questionnaire (HARQ) score after Gefapixant administration | Participant self-reports using the HARQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after 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. |
| Secondary | Change in Cough Severity Diary (CSD) score after Gefapixant administration | Participant self-reports using the CSD will be collected every day for 12 weeks after the start of Gefapixant administration. | 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. |
| Secondary | Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant withdrawal | Cough thresholds will be determined 1 week after Gefapixant withdrawal (Week 13). | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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