Chronic CoughPhase 3NCT04525885

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension

A Phase 3 study testing Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID and Gefapixant 45 mg BID in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Cough
What is being tested?: Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID and Gefapixant 45 mg BID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 161 participants
Where: 8 sitesChina
Study dates: 17 May 2019to 15 Sep 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Who cannot join

Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
Has a history of malignancy <=5 years

Show all 11Show fewer

Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
Has a known allergy/sensitivity or contraindication to gefapixant
Has donated or lost >=1 unit of blood within 8 weeks prior to the first dose of gefapixant
Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

Peking University Third Hospital ( Site 5005)
Beijing, 100191
The First Affiliated Hospital of Fujian Medical University ( Site 5017)
Fuzhou, Fujian, 350005
The First Affiliated Hospital of Guangzhou Medical University ( Site 5000)
Guangzhou, Guangdong, 510120
The First Affiliated Hospital of Zhejiang University ( Site 5014)
Hangzhou, Zhejiang, 310003
Inner Mongolia Autonomous Region Hospital ( Site 5018)
Hohhot, Inner Mongolia, 010017
The First Affiliated Hospital of Nanchang University ( Site 5012)
Nanchang, Jiangxi, 330006
Shanghai General Hospital ( Site 5010)
Shanghai, Shanghai Municipality, 200080
ShengJing Hospital of China Medical University ( Site 5024)
Shenyang, Liaoning, 110004

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)

Read the detailed description

This study will have a main 24-week treatment period and a 28-week extension period of treatment. Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 3-month, Off-treatment Durability Study Period.

Conditions: Chronic Cough
Being tested: Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID, Placebo, Gefapixant 45 mg BID
Medical subject headings: Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gefapixant 45 mg twice daily (BID)Drug
Also called MK-7264
Gefapixant 45 mg tablet to be administered orally BID
Gefapixant 15 mg BIDDrug
Also called MK-7264
Gefapixant 15 mg tablet to be administered orally BID
PlaceboDrug
Placebo tablet administered orally BID
Gefapixant 45 mg BIDDrug
Also called MK-7264
Gefapixant 45 mg tablet to be administered orally BID

Study groups in NCT04525885
Study group	Role	What they receive
Gefapixant 45 mg BID	Experimental	Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). Receives: Drug: Gefapixant 45 mg twice daily (BID); Drug: Gefapixant 45 mg BID
Gefapixant 15 mg BID	Experimental	Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). Receives: Drug: Gefapixant 15 mg BID
Placebo	Placebo comparator	Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Measured: Baseline, Week 24
Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Measured: Up to 54 weeks
Percentage of Participants Who Discontinued Treatment Due to an AE
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
Measured: Up 52 weeks

Secondary outcomes (6)

Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
Measured: Baseline, Week 24
Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. Higher scores indicate better HRQoL. A clinically meaningful improvement from baseline in HRQoL was defined as ≥1.3-point increase in the LCQ total score at Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
Measured: Baseline, Week 24
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≥30% reduction in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≥30% reduction from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Measured: Baseline, Week 24
Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥1.3 point reduction from baseline in CSD at Week 24 is reported.
Measured: Baseline, Week 24
Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥2.7 point reduction from baseline in CSD at Week 24 is reported.
Measured: Baseline, Week 24
Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≥30mm reduction from baseline in cough severity VAS score at Week 24 is reported.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201915 Sep 2022

First posted25 Aug 2020
Study start17 May 2019
Primary completion15 Sep 2022
Study completion15 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic CoughStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04525885
Sponsor's protocol ID: 7264-030 China Extension
Other IDs: MK-7264-030, MK-7264-030-02
Status last verified: Jan 2024
First submitted: 18 Aug 2020
Last updated: 12 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)
ClinicalTrials.gov ID: NCT04525885
Acronym / sponsor ID: 7264-030 China Extension
Conditions: Chronic Cough
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 May 2019 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 15 Sep 2022 (actual)
First posted: 25 Aug 2020 (actual)
Results: Posted 2 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Participants with refractory or unexplained chronic cough will be randomized to 1 of 3 treatment groups: gefapixant 45 mg twice daily (BID), gefapixant 15 mg BID, or placebo.

Arm	Type	Receives
Gefapixant 45 mg BID	Experimental	Drug: Gefapixant 45 mg twice daily (BID), Drug: Gefapixant 45 mg BIDParticipants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).
Gefapixant 15 mg BID	Experimental	Drug: Gefapixant 15 mg BIDParticipants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks).
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Key exclusion criteria (11 listed)

Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 at Screening OR an eGFR ≥30 mL/min/1.73 m^2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gefapixant 45 mg twice daily (BID)Also: MK-7264Gefapixant 45 mg tablet to be administered orally BID	Drug	Gefapixant 45 mg BID
Gefapixant 15 mg BIDAlso: MK-7264Gefapixant 15 mg tablet to be administered orally BID	Drug	Gefapixant 15 mg BID
PlaceboPlacebo tablet administered orally BID	Drug	Placebo
Gefapixant 45 mg BIDAlso: MK-7264Gefapixant 45 mg tablet to be administered orally BID	Drug	Gefapixant 45 mg BID

Primary outcome

Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24
Time frame: Baseline, Week 24
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
Time frame: Up to 54 weeks
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
Percentage of Participants Who Discontinued Treatment Due to an AE
Time frame: Up 52 weeks
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).

6 secondary outcomes

Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Time frame: Baseline, Week 24
Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24
Time frame: Baseline, Week 24
Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 2 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	68	52
Gefapixant 15 mg BID	27	21
Gefapixant 45 mg Twice Daily (BID)	66	45

Primary outcome: Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24

Time frame: Baseline, Week 24. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Placebo n = 65	Gefapixant 45 mg Twice Daily (BID) n = 64
Value	0.47 (0.35 to 0.64)	0.51 (0.37 to 0.71)

Placebo vs Gefapixant 45 mg Twice Daily (BID): Estimated Relative Reduction (%): 8.70 (95% CI -30.51 to 70.03), p = 0.713, ANCOVA

Population analysed: All China participants randomized to the gefapixant 45 mg BID or placebo groups who received at least 1 dose of study intervention. Participants needed to have baseline and at least 1 post-baseline measurement. Efficacy evaluation of the gefapixant 15 mg BID group was removed from the study objectives of the China cohort per protocol amendment 5. Participants were analyzed in the group as randomized.

Primary outcome: Percentage of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up

Time frame: Up to 54 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 67	Gefapixant 15 mg BID n = 27	Gefapixant 45 mg Twice Daily (BID) n = 66
Value	54	20	58

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

Primary outcome: Percentage of Participants Who Discontinued Treatment Due to an AE

Time frame: Up 52 weeks. Count of participants. Unit: Participants

Measure	Gefapixant 45 mg Twice Daily (BID) n = 67	Gefapixant 15 mg BID n = 27	Placebo n = 66
Value	0	1	5

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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 67 (6%)	42 of 67 (62.7%)	0 of 68
MK-7264 15 mg BID	4 of 27 (14.8%)	17 of 27 (63%)	0 of 27
MK-7264 45 mg BID	2 of 66 (3%)	53 of 66 (80.3%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefapixant 45 mg twice daily (BID), Gefapixant 15 mg BID and Gefapixant 45 mg BID in people with Chronic Cough, run by Merck Sharp & Dohme LLC at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24 (time frame: Baseline, Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.