Chronic Refractory CoughPhase 2NCT02993822
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
A Phase 2 study testing Orvepitant Maleate in people with Chronic Refractory Cough, run by Nerre Therapeutics Ltd. at 66 sites in 3 countries.
Trial summary
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Refractory Cough
- What is being tested?
- Orvepitant Maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 66 sitesin 3 countries
- Study dates
- 22 May 2017to 24 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥18 years of age.
- Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
- An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.
Who cannot join
- Subjects with respiratory tract infection (<4 weeks prior to study start)
- Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
- Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
- FEV1 <80% predicted, measured at screening using spirometry
- History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
- Any clinically significant abnormal laboratory test result(s)
- Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Trial locations and contacts
66 sites in 3 countries.
66 sites in 3 countries
United States46 sites
Study Site 34
Baltimore, Maryland, 21236
Study Site 14
Bellingham, Washington, 98225
Study Site 25
Centennial, Colorado, 80112
Study Site 15
Chandler, Arizona, 85224
Study Site 21
Charleston, South Carolina, 29420
Study Site 72
Charleston, South Carolina, 29464
Study Site 55
Charlotte, North Carolina, 28204
Study Site 24
Charlotte, North Carolina, 28207
Study Site 53
Charlotte, North Carolina, 29732
Study Site 19
Charlottesville, Virginia, 22911
Study Site 56
Cincinnati, Ohio, 45231
Study Site 68
Clearwater, Florida, 33765
Study Site 36
Colorado Springs, Colorado, 80907
Study Site 22
Dallas, Texas, 75231
Study Site 35
Dallas, Texas, 75231
Study Site 38
East Providence, Rhode Island, 02914
Study Site 42
Edina, Minnesota, 55435
Study Site 50
Gastonia, North Carolina, 28054
Study Site 13
Greenfield, Wisconsin, 53228
Study Site 54
Greensboro, North Carolina, 27403
Study Site 10
Houston, Texas, 77074
Study Site 59
Jacksonville, Florida, 32224
Study Site 12
Largo, Florida, 33778
Study Site 16
Las Vegas, Nevada, 89128
Study Site 43
Los Angeles, California, 90025
Study Site 60
Meridian, Idaho, 83642
Study Site 62
Miami, Florida, 33060
Study Site 57
Miami, Florida, 33186
Study Site 41
Minneapolis, Minnesota, 55402
Study Site 52
Mission Viejo, California, 92692
Study Site 27
Missoula, Montana, 59808
Study Site 73
Mooresville, North Carolina, 28117
Study Site 39
Normal, Illinois, 61761
Study Site 74
Oklahoma City, Oklahoma, 73131
Study Site 71
Raleigh, North Carolina, 27612
Study Site 37
Rochester, Minnesota, 55905
Study Site 32
Rochester, New York, 14618
Study Site 58
Salt Lake City, Utah, 84108
Study Site 49
San Antonio, Texas, 78229
Study Site 20
San Diego, California, 92108
Study Site 28
San Jose, California, 95117
Study Site 33
Tampa, Florida, 33613
Study Site 26
Tulsa, Oklahoma, 74136
Study Site 23
Waco, Texas, 76712
Study Site 48
Waterbury, Connecticut, 06708
Study Site 11
Winter Park, Florida, 32789
United Kingdom17 sites
Study Site 96
Barnsley, South Yorkshire, S75 3DL
Study Site 40
Belfast, Northern Ireland, BT9 7AB
Study Site 94
Blackpool, Lancashire, FY2 0JH
Study Site 97
Cannock, Staffordshire, WS11 0BN
Study Site 45
Hull
Study Site 92
Leeds, LS10 1DU
Study Site 30
Leicester
Study Site 46
London
Study Site 91
Manchester, M32 0UT
Study Site 18
Manchester
Study Site 47
Newcastle upon Tyne
Study Site 31
North Shields
Study Site 17
Northwood, Middlesex
Study Site44
Oxford
Study Site 93
Prescot, Merseyside, L34 1BH
Study Site 29
Romford, Essex, RM1 3PJ
Study Site 95
Stockton-on-Tees, Teesside, TS17 6EW
Canada3 sites
Study Site 66
Niagara Falls, Ontario, L2G 1J4
Study Site 65
Québec, Quebec, G1V 4W2
Study Site 64
Trois-Rivières, Quebec, G8T 7A1
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.
Read the detailed description
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total).
All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.
- Conditions
- Chronic Refractory Cough
- Being tested
- Orvepitant Maleate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orvepitant MaleateDrug
Tablet, once daily, oral
PlaceboDrug
Tablet, once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Orvepitant 10mg | Experimental | Orvepitant 10mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant Maleate |
| Orvepitant 20mg | Experimental | Orvepitant 20mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant Maleate |
| Orvepitant 30mg | Experimental | Orvepitant 30mg tablet, once daily for 12 weeks Receives: Drug: Orvepitant Maleate |
| Placebo | Placebo comparator | Placebo to match tablet, once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Awake Objective Cough Frequency
Objective cough frequency measured by ambulatory cough monitoring device
Measured: Baseline to Week 12
Secondary outcomes (26)
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
Measured: Baseline to Week 2
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
Measured: Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Global Rating of Change in Cough Frequency at Week 2
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Global Rating of Change in Cough Frequency at Week 4
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Global Rating of Change in Cough Frequency at Week 8
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Global Rating of Change in Cough Frequency at Week 12
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Global Rating of Change in Cough Severity at Week 2
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 2
Global Rating of Change in Cough Severity at Week 4
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 4
Global Rating of Change in Cough Severity at Week 8
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 8
Global Rating of Change in Cough Severity at Week 12
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start22 May 2017
- Primary completion14 Jan 2019
- Study completion24 Jan 2019
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 Refractory 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerre Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993822
- Sponsor's protocol ID
- VOLCANO-2
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2016
- Last updated
- 26 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
- ClinicalTrials.gov ID
- NCT02993822
- Acronym / sponsor ID
- VOLCANO-2
- Conditions
- Chronic Refractory Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Nerre Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.
Detailed description
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total).
All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.
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 |
|---|---|---|
| Orvepitant 10mg | Experimental | Drug: Orvepitant MaleateOrvepitant 10mg tablet, once daily for 12 weeks |
| Orvepitant 20mg | Experimental | Drug: Orvepitant MaleateOrvepitant 20mg tablet, once daily for 12 weeks |
| Orvepitant 30mg | Experimental | Drug: Orvepitant MaleateOrvepitant 30mg tablet, once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match tablet, once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects ≥18 years of age.
- Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
- An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.
Key exclusion criteria (7 listed)
- Subjects with respiratory tract infection (<4 weeks prior to study start)
- Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
- Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
- FEV1 <80% predicted, measured at screening using spirometry
- History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| Orvepitant MaleateTablet, once daily, oral | Drug | Orvepitant 10mg, Orvepitant 20mg, Orvepitant 30mg |
| PlaceboTablet, once daily, oral | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in Awake Objective Cough Frequency
Time frame: Baseline to Week 12
Objective cough frequency measured by ambulatory cough monitoring device
26 secondary outcomes
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
Time frame: Baseline to Week 2
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
Time frame: Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline
Time frame: Baseline to Week 2
Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline
Time frame: Baseline to Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline
Time frame: Baseline to Week 8
Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline
Time frame: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time
Time frame: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time
Time frame: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time
Time frame: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time
Time frame: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time
Time frame: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time
Time frame: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time
Time frame: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time
Time frame: Baseline to Week 12
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline
Time frame: Baseline to Week 2
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline
Time frame: Baseline to Week 4
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline
Time frame: Baseline to Week 8
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline
Time frame: Baseline to Week 12
Global Rating of Change in Cough Frequency at Week 2
Time frame: Baseline to Week 2
Global Rating of Change in Cough Frequency at Week 4
Time frame: Baseline to Week 4
Global Rating of Change in Cough Frequency at Week 8
Time frame: Baseline to Week 8
Global Rating of Change in Cough Frequency at Week 12
Time frame: Baseline to Week 12
Global Rating of Change in Cough Severity at Week 2
Time frame: Baseline to Week 2
Global Rating of Change in Cough Severity at Week 4
Time frame: Baseline to Week 4
Global Rating of Change in Cough Severity at Week 8
Time frame: Baseline to Week 8
Global Rating of Change in Cough Severity at Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
66 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orvepitant Maleate in people with Chronic Refractory Cough, run by Nerre Therapeutics Ltd. at 66 sites in 3 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 3 inclusion and 7 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, United Kingdom, Canada. 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 26 Apr 2022). 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 to Week 12 in Awake Objective Cough Frequency (time frame: Baseline to Week 12). 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 26 Apr 2022.