Refractory Chronic CoughPhase 2NCT03282591

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

A Phase 2 study testing 5 mg Serlopitant Tablets in people with Refractory Chronic Cough, run by Vyne Therapeutics Inc. at 39 sites in 2 countries.

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

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of 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?: 5 mg Serlopitant Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 185 participants
Where: 39 sitesin 2 countries
Study dates: 3 Oct 2017to 6 Sep 2018
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

Female and males between 18 and 80 years of age
Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
At Screening have a score of ≥ 40mm on the Cough Severity VAS
At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. Please refer to the protocol for acceptable methods of contraception

Who cannot join

Prior treatment with serlopitant or other NK1-R antagonist
Presence of any medical condition or disability that could interfere with study
History of hypersensitivity to serlopitant or any of its components
Currently pregnant or male partner of pregnant female
Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
Current smoker or individuals who have given up smoking within the past 12 months

Show all 21Show fewer

FEV1/FVC < 60%
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2 at Screening
History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
History of cystic fibrosis
History of opioid use within 1 week of the Baseline Visit (Day 0)
Requiring concomitant therapy with prohibited medications
Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
Positive test for any drug of abuse
History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
Known active hepatitis infection
Known history of human immunodeficiency virus (HIV) infection

Trial locations and contacts

39 sites in 2 countries.

Country

City, postcode or hospital

39 sites in 2 countries

United States29 sites

Study Site 126
Bellingham, Washington, 98225
Study Site 129
Charleston, North Carolina, 29420
Study Site 103
Charlotte, North Carolina, 28207
Study Site 122
Cincinnati, Ohio, 45231
Study Site 106
Colorado Springs, Colorado, 80907
Study Site 113
Colorado Springs, Colorado, 80907
Study Site 102
Dallas, Texas, 75231
Study Site 120
Dallas, Texas, 75231
Study Site 108
Denver, Colorado, 80230
Study Site 117
Eugene, Oregon, 97401
Study Site 111
Gastonia, North Carolina, 28054
Study Site 105
Greenfield, Wisconsin, 53228
Study Site 118
Largo, Florida, 33778
Study Site 130
Los Angeles, California, 90048
Study Site 128
Mission Viejo, California, 92691
Study Site 114
Mooresville, North Carolina, 28117
Study Site 121
Ocean Township, New Jersey, 07712
Study Site 115
Plymouth, Minnesota, 55441
Study Site 116
Portland, Oregon, 97202
Study Site 110
Rochester, Minnesota, 55905
Study Site 125
Rochester, New York, 14618
Study Site 104
Rock Hill, South Carolina, 29732
Study Site 101
San Antonio, Texas, 78229
Study Site 123
San Diego, California, 92108
Study Site 127
San Jose, California, 95117
Study Site 131
Stockton, California, 95207
Study Site 112
Tulsa, Oklahoma, 74136
Study Site 109
Waco, Texas, 76712
Study Site 107
Winter Park, Florida, 32789

Other trials in United States

United Kingdom10 sites

Study Site 133
Belfast, BT9 7AB
Study Site 139
Birmingham, B9 5SS
Study Site 136
Cottingham, HU16 5JQ
Study Site 141
Llanelli, SA14 8QF
Study Site 138
London, SE5 9RS
Study Site 137
London, SW3 6HP
Study Site 132
Manchester, M23 9LT
Study Site 135
Oxford, OX3 7LE
Study Site 134
Preston, PR2 9HT
Study Site 140
Taunton, TA2 5DA

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough

Conditions: Refractory Chronic Cough
Being tested: 5 mg Serlopitant Tablets, Matching Placebo Tablets
Medical subject headings: Chronic Cough

What participants receive

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

5 mg Serlopitant TabletsDrug
Also called VPD-737
Serlopitant Tablets
Matching Placebo TabletsDrug
Placebo Tablets

Study groups in NCT03282591
Study group	Role	What they receive
5 mg Serlopitant Tablets	Experimental	Serlopitant Tablets Receives: Drug: 5 mg Serlopitant Tablets
Matching Placebo Tablets	Placebo comparator	Placebo Tablets Receives: Drug: Matching Placebo Tablets

What is being measured

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

Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Measured: from Baseline to Day 84

Secondary outcomes (4)

Change in Awake Objective Cough Frequency
Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Measured: from Baseline to Day 84
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Measured: from Baseline to Day 84
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
Measured: from Baseline to Day 84
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.
Measured: from Baseline to Day 84

Timeline

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

3 Oct 20176 Sep 2018

First posted14 Sep 2017
Study start3 Oct 2017
Primary completion15 Aug 2018
Study completion6 Sep 2018

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: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03282591
Sponsor's protocol ID: MTI-110
Other IDs: 2017-003250-16, 2017
Status last verified: May 2021
First submitted: 11 Sep 2017
Last updated: 20 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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

RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
Refractory Chronic Cough and Unexplained Chronic Cough
RecruitingPhase 2
Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
Chronic Cough (CC), Refractory Chronic Cough
Active, not recruitingPhase 3
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Cough, Refractory Chronic Cough

All Refractory Chronic Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
ClinicalTrials.gov ID: NCT03282591
Acronym / sponsor ID: MTI-110
Conditions: Refractory Chronic Cough
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 3 Oct 2017 (actual)
Primary completion: 15 Aug 2018 (actual)
Study completion: 6 Sep 2018 (actual)
First posted: 14 Sep 2017 (actual)
Results: Posted 22 Oct 2019

Clinical summary

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

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of 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: 2

Arm	Type	Receives
5 mg Serlopitant Tablets	Experimental	Drug: 5 mg Serlopitant TabletsSerlopitant Tablets
Matching Placebo Tablets	Placebo comparator	Drug: Matching Placebo TabletsPlacebo Tablets

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Female and males between 18 and 80 years of age
Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
At Screening have a score of ≥ 40mm on the Cough Severity VAS
At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS

Key exclusion criteria (21 listed)

Prior treatment with serlopitant or other NK1-R antagonist
Presence of any medical condition or disability that could interfere with study
History of hypersensitivity to serlopitant or any of its components
Currently pregnant or male partner of pregnant female
Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding

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
5 mg Serlopitant TabletsAlso: VPD-737Serlopitant Tablets	Drug	5 mg Serlopitant Tablets
Matching Placebo TabletsPlacebo Tablets	Drug	Matching Placebo Tablets

Primary outcome

Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
Time frame: from Baseline to Day 84
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).

4 secondary outcomes

Change in Awake Objective Cough Frequency
Time frame: from Baseline to Day 84
Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency
Time frame: from Baseline to Day 84
Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency
Time frame: from Baseline to Day 84
Change From Baseline in Cough Severity Visual Analog Scale (VAS)
Time frame: from Baseline to Day 84

Results and safety

Results posted to the registry on 22 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Serlopitant 5 mg	92	88
Placebo	93	89

Primary outcome: Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)

Time frame: from Baseline to Day 84. Least squares mean (Standard Error). Unit: coughs/hr

Measure	Serlopitant 5 mg n = 88	Placebo n = 88
Value	-0.18 (0.09)	-0.45 (0.08)

Serlopitant 5 mg vs Placebo: Mean Difference (Final Values): 31.4, p = 0.9942, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at approximately Day 112 (± 3 days). After the Follow-Up visit, only SAEs that are believed to be drug related will be reported, without a specific end time.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Serlopitant 5 mg	3 of 92 (3.3%)	43 of 92 (46.7%)	1 of 92
Placebo	3 of 92 (3.3%)	28 of 92 (30.4%)	0 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractory Chronic Cough

RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
Refractory Chronic Cough and Unexplained Chronic Cough
RecruitingPhase 2
Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
Chronic Cough (CC), Refractory Chronic Cough
Active, not recruitingPhase 3
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Cough, Refractory Chronic Cough

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.

Jacky Smith principal investigator

University of Manchester, United Kingdom

39 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5 mg Serlopitant Tablets in people with Refractory Chronic Cough, run by Vyne Therapeutics Inc. at 39 sites in 2 countries.

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 6 inclusion and 21 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 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, United Kingdom. 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 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 22 Oct 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 in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo) (time frame: from Baseline to Day 84). 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 NCT03282591.

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 20 May 2021.