Refractory Chronic CoughPhase 2NCT02612623
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
A Phase 2 study testing Gefapixant in people with Refractory Chronic Cough, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 10 sites in United States.
Trial summary
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- Gefapixant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Dec 2015to 18 May 2016
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and Men between 18 and 80 years of age inclusive
- Have refractory chronic cough
- Women of child-bearing potential must use 2 forms of acceptable birth control
- Have provided written informed consent.
- Are willing and able to comply with all aspects of the protocol.
Who cannot join
- Current smoker
- Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
- History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
- History of opioid use within 1 week of the Baseline Visit
- Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
- History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
Show all 11Show fewer
- Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- Significantly abnormal laboratory tests at Screening
- Clinically significant abnormal electrocardiogram (ECG)
- Pregnant or Breastfeeding
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Afferent Investigative Site
Bellevue, Washington
Afferent Investigative Site
Charlotte, North Carolina
Afferent Investigative Site
Colorado Springs, Colorado
Afferent Investigative Site
Dallas, Texas
Afferent Investigative Site
Greenfield, Wisconsin
Afferent Investigative Site
Largo, Florida
Afferent Investigative Site
Mission Viejo, California
Afferent Investigative Site
San Antonio, Texas
Afferent Investigative Site
San Jose, California
Afferent Investigative Site
Tulsa, Oklahoma
About this study
Official title: A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
- Conditions
- Refractory Chronic Cough
- Being tested
- Gefapixant, Placebo (for gefapixant)
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant tablets administered by mouth twice daily for 8 weeks
Placebo (for gefapixant)Drug
Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant 15 mg twice daily | Experimental | Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks Receives: Drug: Gefapixant |
| Gefapixant 30 mg twice daily | Experimental | Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks Receives: Drug: Gefapixant |
| Gefapixant 50 mg twice daily | Experimental | One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks Receives: Drug: Gefapixant |
| Placebo to match gefapixant | Experimental | Matching placebo tablets administered by mouth twice daily for 8 weeks Receives: Drug: Placebo (for gefapixant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
Measured: Baseline and Week 8 (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start17 Dec 2015
- Primary completion4 May 2016
- Study completion18 May 2016
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 Refractory Chronic CoughStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612623
- Sponsor's protocol ID
- 7264-021
- Other IDs
- AF219-021, MK-7264-021
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2015
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
- ClinicalTrials.gov ID
- NCT02612623
- Acronym / sponsor ID
- 7264-021
- Conditions
- Refractory Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 18 May 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gefapixant 15 mg twice daily | Experimental | Drug: GefapixantTwo 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| Gefapixant 30 mg twice daily | Experimental | Drug: GefapixantFour 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks |
| Gefapixant 50 mg twice daily | Experimental | Drug: GefapixantOne 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks |
| Placebo to match gefapixant | Experimental | Drug: Placebo (for gefapixant)Matching placebo tablets administered by mouth twice daily for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and Men between 18 and 80 years of age inclusive
- Have refractory chronic cough
- Women of child-bearing potential must use 2 forms of acceptable birth control
- Have provided written informed consent.
- Are willing and able to comply with all aspects of the protocol.
Key exclusion criteria (11 listed)
- Current smoker
- Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
- History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
- History of opioid use within 1 week of the Baseline Visit
- Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
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 |
|---|---|---|
| GefapixantAlso: AF-219, MK-7264Gefapixant tablets administered by mouth twice daily for 8 weeks | Drug | Gefapixant 15 mg twice daily, Gefapixant 30 mg twice daily, Gefapixant 50 mg twice daily |
| Placebo (for gefapixant)Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks | Drug | Placebo to match gefapixant |
Primary outcome
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
Time frame: Baseline and Week 8 (Day 56)
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefapixant in people with Refractory Chronic Cough, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 10 sites in United States.
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 5 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Nov 2019). 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?
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment. (time frame: Baseline and Week 8 (Day 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2019.