Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542484
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
The Real-world Treatment Satisfaction by Gefapixiant in RCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Real-world Treatment Satisfaction by Gefapixiant in Patients With Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance The RESTORE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic cough has a high global prevalence and it is refractory to such treatments by approximately 20 of patients Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with refractory chronic coughRCC Taste disturbance is the most frequent adverse event by gefapixant approximately 60-70 Although gefapixant is well-tolerated even if taste disturbance has occurred the impact of taste disturbance on cough-specific QoL remains to be unclear Therefore the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients
Detailed Description:
Chronic cough has a high global prevalence but appears to be poorly recognized Most patients respond to specific treatments against causes of chronic cough Meanwhile cough is refractory to such treatments by approximately 20 of patients and they are regarded as refractory chronic cough RCC Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with RCC through the inhibition of ATP transmission to afferent nerves According to the COUGH-1 and COUGH-2 taste disturbance is the most frequent adverse event by gefapixant with the incidence of 593 in COUGH-1 and 689 in COUGH-2 respectively Although 45 mg of gefapixant is well-tolerated even if taste disturbance has occurred the impact of taste disturbance on cough-specific QoL remains to be unclear in RCC and UCC Furthermore both taste disturbance and the improvement of cough by gefapixant would be associated with treatment satisfaction Therefore the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients The investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients Furthermore the investigator would like to evaluate the association of taste disturbance with cough-specific QoL in the real-world clinical practice In addition there are no biomarkers available that can predict the efficacy of the improvement of cough by gefapixant The investigator will also explore biomarkers that can be helpful in predicting well response to gefapixant in RCC and UCC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None