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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
Scientific title
The Effect of Acute and Prolonged Administration of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
Secondary ID [1] 0 0
2023.005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Cough 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in cough-related brain activity using brain imaging following Gefapixant administration
Timepoint [1] 0 0
Gefapixant administration will be for 12 weeks with brain scans to be performed before, 3 days after, and 12 weeks after dosing.
Primary outcome [2] 0 0
Change in cough-related brain activity using brain imaging following Gefapixant withdrawal
Timepoint [2] 0 0
Brain imaging will be performed 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [1] 0 0
Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant administration
Timepoint [1] 0 0
Cough thresholds will be determined before, 3 days after and 12 weeks after Gefapixant dosing.
Secondary outcome [2] 0 0
Change in Urge To Cough Visual Analogue Scale (UTCVAS) score after Gefapixant administration
Timepoint [2] 0 0
Participant self-reports using the UTCVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
Secondary outcome [3] 0 0
Change in Cough Visual Analogue Scale (CVAS) score after Gefapixant administration
Timepoint [3] 0 0
Participant self-reports using the CVAS will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
Secondary outcome [4] 0 0
Change in Leicester Cough Questionnaire (LCQ) score after Gefapixant administration
Timepoint [4] 0 0
Participant self-reports using the LCQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
Secondary outcome [5] 0 0
Change in Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score after Gefapixant administration
Timepoint [5] 0 0
Participant self-reports using the NLHQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
Secondary outcome [6] 0 0
Change in Hull Airway Reflux Questionnaire (HARQ) score after Gefapixant administration
Timepoint [6] 0 0
Participant self-reports using the HARQ will be collected before and 3 days, 4 weeks, 8 weeks and 12 weeks after Gefapixant dosing.
Secondary outcome [7] 0 0
Change in Cough Severity Diary (CSD) score after Gefapixant administration
Timepoint [7] 0 0
Participant self-reports using the CSD will be collected every day for 12 weeks after the start of Gefapixant administration.
Secondary outcome [8] 0 0
Change in capsaicin and ATP cough challenge test sensitivity following Gefapixant withdrawal
Timepoint [8] 0 0
Cough thresholds will be determined 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [9] 0 0
Change in Urge To Cough Visual Analogue Scale (UTCVAS) score following Gefapixant withdrawal
Timepoint [9] 0 0
Participant self-report using the UTCVAS will be collected 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [10] 0 0
Change in Cough Visual Analogue Scale (CVAS) score following Gefapixant withdrawal
Timepoint [10] 0 0
Participant self-report using the CVAS will be collected 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [11] 0 0
Change in Leicester Cough Questionnaire (LCQ) score following Gefapixant withdrawal
Timepoint [11] 0 0
Participant self-report using the LCQ will be collected 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [12] 0 0
Change in Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score following Gefapixant withdrawal
Timepoint [12] 0 0
Participant self-report using the NHLQ will be collected 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [13] 0 0
Change in Hull Airway Reflux Questionnaire (HARQ) score following Gefapixant withdrawal
Timepoint [13] 0 0
Participant self-report using the HARQ will be collected 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [14] 0 0
Change in Cough Severity Diary (CSD) score following Gefapixant withdrawal
Timepoint [14] 0 0
Participant self-report using the CSD will be collected every day in the 1 week after Gefapixant withdrawal (Week 13).
Secondary outcome [15] 0 0
Sustainability of Gefapixant treatment effects on cough challenge sensitivity.
Timepoint [15] 0 0
Cough thresholds will be determined at 6 and 12 months (relative to start of study).
Secondary outcome [16] 0 0
Sustainability of Gefapixant treatment effects on Urge To Cough Visual Analogue Scale (UTCVAS) score
Timepoint [16] 0 0
Participant self-report using the UTCVAS will be collected at 6 and 12 months (relative to start of study).
Secondary outcome [17] 0 0
Sustainability of Gefapixant treatment effects on Cough Visual Analogue Scale (CVAS) score
Timepoint [17] 0 0
Participant self-report using the CVAS will be collected at 6 and 12 months (relative to start of study).
Secondary outcome [18] 0 0
Sustainability of Gefapixant treatment effects on Leicester Cough Questionnaire (LCQ) score
Timepoint [18] 0 0
Participant self-report using the LCQ will be collected at 6 and 12 months (relative to start of study).
Secondary outcome [19] 0 0
Sustainability of Gefapixant treatment effects on Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ) score
Timepoint [19] 0 0
Participant self-report using the NLHQ will be collected at 6 and 12 months (relative to start of study).
Secondary outcome [20] 0 0
Sustainability of Gefapixant treatment effects on Hull Airway Reflux Questionnaire (HARQ) score
Timepoint [20] 0 0
Participant self-report using the HARQ will be collected at 6 and 12 months (relative to start of study).
Secondary outcome [21] 0 0
Sustainability of Gefapixant treatment effects on Cough Severity Diary (CSD) score
Timepoint [21] 0 0
Participant self-report using the CSD will be collected every day from Week 14 until 12 months (relative to start of study).

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3010 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Stuart Mazzone
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart B Mazzone, PhD
Address 0 0
+61383446457
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stuart B Mazzone, PhD
Address 0 0
Country 0 0
Phone 0 0
+61383446457
Fax 0 0
Email 0 0
stuart.mazzone@unimelb.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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