Trial Outcomes & Findings for Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043) (NCT NCT04193202)

NCT ID: NCT04193202

Last Updated: 2023-05-16

Results Overview

Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

419 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Gefapixant Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Overall Study STARTED	208	211
Overall Study Treated	206	209
Overall Study COMPLETED	192	201
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefapixant Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Overall Study Adverse Event	2	1
Overall Study Death	0	1
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	11	5

Baseline Characteristics

Includes randomized participants who had LCQ total score values at baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefapixant n=208 Participants Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=211 Participants Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.	Total n=419 Participants Total of all reporting groups
Age, Continuous	52.6 Years STANDARD_DEVIATION 13.8 • n=208 Participants	52.5 Years STANDARD_DEVIATION 13.7 • n=211 Participants	52.6 Years STANDARD_DEVIATION 13.7 • n=419 Participants
Sex: Female, Male Female	136 Participants n=208 Participants	135 Participants n=211 Participants	271 Participants n=419 Participants
Sex: Female, Male Male	72 Participants n=208 Participants	76 Participants n=211 Participants	148 Participants n=419 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	71 Participants n=208 Participants	76 Participants n=211 Participants	147 Participants n=419 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=208 Participants	134 Participants n=211 Participants	270 Participants n=419 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=208 Participants	1 Participants n=211 Participants	2 Participants n=419 Participants
Race (NIH/OMB) American Indian or Alaska Native	22 Participants n=208 Participants	28 Participants n=211 Participants	50 Participants n=419 Participants
Race (NIH/OMB) Asian	3 Participants n=208 Participants	2 Participants n=211 Participants	5 Participants n=419 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=208 Participants	0 Participants n=211 Participants	0 Participants n=419 Participants
Race (NIH/OMB) Black or African American	3 Participants n=208 Participants	0 Participants n=211 Participants	3 Participants n=419 Participants
Race (NIH/OMB) White	151 Participants n=208 Participants	152 Participants n=211 Participants	303 Participants n=419 Participants
Race (NIH/OMB) More than one race	29 Participants n=208 Participants	29 Participants n=211 Participants	58 Participants n=419 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=208 Participants	0 Participants n=211 Participants	0 Participants n=419 Participants
Baseline Leicester Cough Questionnaire (LCQ)	10.8 Scores on a scale STANDARD_DEVIATION 3.1 • n=202 Participants • Includes randomized participants who had LCQ total score values at baseline	11.3 Scores on a scale STANDARD_DEVIATION 2.8 • n=200 Participants • Includes randomized participants who had LCQ total score values at baseline	11.0 Scores on a scale STANDARD_DEVIATION 3.0 • n=402 Participants • Includes randomized participants who had LCQ total score values at baseline

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who have taken at least one dose of study intervention, and had LCQ total score values at both baseline and week 12. Participants were analyzed in the group as randomized.

Outcome measures

Outcome measures
Measure	Gefapixant n=199 Participants Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=199 Participants Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12	4.34 Scores on a Scale Interval 3.84 to 4.83	3.59 Scores on a Scale Interval 3.09 to 4.09

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who have taken at least one dose of study intervention, and had VAS total score values at both baseline and week 12. Participants were analyzed in the group as randomized.

Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated.

Outcome measures

Outcome measures
Measure	Gefapixant n=201 Participants Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=205 Participants Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12	-31.79 Scores on a Scale Interval -35.37 to -28.2	-24.87 Scores on a Scale Interval -28.41 to -21.32

SECONDARY outcome

Timeframe: Up to approximately 14 weeks

Population: All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs is presented.

Outcome measures

Outcome measures
Measure	Gefapixant n=206 Participants Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=209 Participants Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Percentage of Participants With One or More Adverse Events (AEs)	65.5 Percentage of Participants	43.1 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 12 weeks

Population: All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.

Outcome measures

Outcome measures
Measure	Gefapixant n=206 Participants Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=209 Participants Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Percentage of Participants Who Discontinue Study Drug Due to an AE	11.2 Percentage of Participants	1.9 Percentage of Participants

Adverse Events

Gefapixant

Serious events: 3 serious events

Other events: 105 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Gefapixant n=206 participants at risk Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=209 participants at risk Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Cardiac disorders Myocardial ischaemia	0.49% 1/206 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.00% 0/209 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Infections and infestations COVID-19	0.00% 0/206 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.48% 1/209 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Infections and infestations COVID-19 pneumonia	0.00% 0/206 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.96% 2/209 • Number of events 2 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Infections and infestations Pneumonia	0.49% 1/206 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.00% 0/209 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Injury, poisoning and procedural complications Clavicle fracture	0.49% 1/206 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.00% 0/209 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Psychiatric disorders Depression	0.00% 0/206 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.48% 1/209 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Respiratory, thoracic and mediastinal disorders Tonsillar cyst	0.00% 0/206 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.48% 1/209 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.

Other adverse events

Other adverse events
Measure	Gefapixant n=206 participants at risk Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.	Placebo n=209 participants at risk Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Nervous system disorders Ageusia	11.7% 24/206 • Number of events 24 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.00% 0/209 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Nervous system disorders Dysgeusia	32.0% 66/206 • Number of events 70 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	3.3% 7/209 • Number of events 7 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Nervous system disorders Headache	5.3% 11/206 • Number of events 12 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	6.7% 14/209 • Number of events 15 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
Nervous system disorders Hypogeusia	10.7% 22/206 • Number of events 22 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.	0.48% 1/209 • Number of events 1 • Up to 114 days All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER