Trial Outcomes & Findings for Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013) (NCT NCT03569033)

Results Overview

Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Day 3

Results posted on

2019-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Gefapixant 45 mg BID Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID Participants received a matching placebo tablet BID for 7 days.
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=23 Participants Participants received a matching placebo tablet BID for 7 days.	Total n=46 Participants Total of all reporting groups
Age, Continuous	24.9 Years STANDARD_DEVIATION 7.4 • n=5 Participants	24.3 Years STANDARD_DEVIATION 5.6 • n=7 Participants	24.6 Years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3

Population: All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with human rhinovirus type 16 (HRV-16)

Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=19 Participants Participants received a matching placebo tablet BID for 7 days.
Awake Coughs Per Hour on Day 3	2.38 Coughs per hour Interval 1.01 to 3.75	2.70 Coughs per hour Interval 1.21 to 4.19

SECONDARY outcome

Timeframe: Baseline and Day 3

Population: All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16

The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=19 Participants Participants received a matching placebo tablet BID for 7 days.
Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3	6.07 Scores on a scale Interval 1.79 to 10.35	5.08 Scores on a scale Interval 0.39 to 9.78

SECONDARY outcome

Timeframe: Baseline and Day 3

Population: All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16

The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of "today" (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=19 Participants Participants received a matching placebo tablet BID for 7 days.
Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3	2.71 Scores on a scale Interval 0.46 to 4.97	1.91 Scores on a scale Interval -0.55 to 4.38

SECONDARY outcome

Timeframe: Baseline and Day 3

Population: All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16

The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=19 Participants Participants received a matching placebo tablet BID for 7 days.
Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3	-0.26 Scores on a scale Interval -0.51 to -0.01	-0.35 Scores on a scale Interval -0.62 to -0.08

SECONDARY outcome

Timeframe: Up to 21 days

Population: All randomized participants who received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=23 Participants Participants received a matching placebo tablet BID for 7 days.
Percentage of Participants Who Experienced One or More Adverse Events (AEs)	100 Percentage of participants	95.7 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 7

Population: All randomized participants who received at least 1 dose of study treatment

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Outcome measures

Outcome measures
Measure	Gefapixant 45 mg BID n=23 Participants Participants received a gefapixant 45 mg tablet twice daily (BID) for 7 days.	Placebo BID n=23 Participants Participants received a matching placebo tablet BID for 7 days.
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)	0.0 Percentage of participants	0.0 Percentage of participants

Adverse Events

MK-7264 45 mg BID

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-7264 45 mg BID n=23 participants at risk Participants received a gefapixant 45 mg tablet BID for 7 days.	Placebo n=23 participants at risk Participants received a matching placebo tablet BID for 7 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	8.7% 2/23 • Number of events 2 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Gastrointestinal disorders Nausea	13.0% 3/23 • Number of events 4 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Gastrointestinal disorders Salivary hypersecretion	8.7% 2/23 • Number of events 2 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
General disorders Medical device site erythema	69.6% 16/23 • Number of events 16 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	73.9% 17/23 • Number of events 17 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Infections and infestations Upper respiratory tract infection	87.0% 20/23 • Number of events 20 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	91.3% 21/23 • Number of events 22 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	8.7% 2/23 • Number of events 2 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Metabolism and nutrition disorders Decreased appetite	8.7% 2/23 • Number of events 2 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	4.3% 1/23 • Number of events 1 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Nervous system disorders Dysgeusia	8.7% 2/23 • Number of events 10 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Nervous system disorders Hypogeusia	13.0% 3/23 • Number of events 5 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 2/23 • Number of events 3 • Up to 21 days All randomized participants who received at least 1 dose of study treatment	0.00% 0/23 • Up to 21 days All randomized participants who received at least 1 dose of study treatment

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the sponsor, 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.
Publication restrictions are in place

Restriction type: OTHER