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A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

Primary Purpose

Chronic Refractory Cough

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Orvepitant Maleate
Placebo
Sponsored by
Nerre Therapeutics Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Refractory Cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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:

  • 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.

Sites / Locations

  • Study Site 15
  • Study Site 43
  • Study Site 52
  • Study Site 20
  • Study Site 28
  • Study Site 25
  • Study Site 36
  • Study Site 48
  • Study Site 68
  • Study Site 59
  • Study Site 12
  • Study Site 62
  • Study Site 57
  • Study Site 33
  • Study Site 11
  • Study Site 60
  • Study Site 39
  • Study Site 34
  • Study Site 42
  • Study Site 41
  • Study Site 37
  • Study Site 27
  • Study Site 16
  • Study Site 32
  • Study Site 55
  • Study Site 24
  • Study Site 53
  • Study Site 50
  • Study Site 54
  • Study Site 73
  • Study Site 71
  • Study Site 56
  • Study Site 74
  • Study Site 26
  • Study Site 38
  • Study Site 21
  • Study Site 72
  • Study Site 22
  • Study Site 35
  • Study Site 10
  • Study Site 49
  • Study Site 23
  • Study Site 58
  • Study Site 19
  • Study Site 14
  • Study Site 13
  • Study Site 66
  • Study Site 65
  • Study Site 64
  • Study Site 29
  • Study Site 94
  • Study Site 93
  • Study Site 17
  • Study Site 40
  • Study Site 96
  • Study Site 97
  • Study Site 95
  • Study Site 45
  • Study Site 92
  • Study Site 30
  • Study Site 46
  • Study Site 91
  • Study Site 18
  • Study Site 47
  • Study Site 31
  • Study Site44

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Orvepitant 10mg

Orvepitant 20mg

Orvepitant 30mg

Placebo

Arm Description

Orvepitant 10mg tablet, once daily for 12 weeks

Orvepitant 20mg tablet, once daily for 12 weeks

Orvepitant 30mg tablet, once daily for 12 weeks

Placebo to match tablet, once daily for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in Awake Objective Cough Frequency
Objective cough frequency measured by ambulatory cough monitoring device

Secondary Outcome Measures

Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 6, 2016
Last Updated
March 31, 2022
Sponsor
Nerre Therapeutics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02993822
Brief Title
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nerre Therapeutics Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Refractory Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orvepitant 10mg
Arm Type
Experimental
Arm Description
Orvepitant 10mg tablet, once daily for 12 weeks
Arm Title
Orvepitant 20mg
Arm Type
Experimental
Arm Description
Orvepitant 20mg tablet, once daily for 12 weeks
Arm Title
Orvepitant 30mg
Arm Type
Experimental
Arm Description
Orvepitant 30mg tablet, once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match tablet, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Orvepitant Maleate
Intervention Description
Tablet, once daily, oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, once daily, oral
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Awake Objective Cough Frequency
Description
Objective cough frequency measured by ambulatory cough monitoring device
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
Description
Objective cough frequency measured by ambulatory cough monitoring device
Time Frame
Baseline to Week 2
Title
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
Description
Objective cough frequency measured by ambulatory cough monitoring device
Time Frame
Week 4
Title
Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 2
Title
Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 8
Title
Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time
Description
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.
Time Frame
Baseline to Week 2
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time
Description
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.
Time Frame
Baseline to Week 8
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time
Description
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.
Time Frame
Baseline to Week 12
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time
Description
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.
Time Frame
Baseline to Week 2
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time
Description
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.
Time Frame
Baseline to Week 8
Title
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time
Description
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.
Time Frame
Baseline to Week 12
Title
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 2
Title
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 8
Title
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Global Rating of Change in Cough Frequency at Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Global Rating of Change in Cough Frequency at Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Global Rating of Change in Cough Frequency at Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Global Rating of Change in Cough Frequency at Week 12
Description
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.
Time Frame
Baseline to Week 12
Title
Global Rating of Change in Cough Severity at Week 2
Description
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.
Time Frame
Baseline to Week 2
Title
Global Rating of Change in Cough Severity at Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Global Rating of Change in Cough Severity at Week 8
Description
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.
Time Frame
Baseline to Week 8
Title
Global Rating of Change in Cough Severity at Week 12
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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: 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.
Facility Information:
Facility Name
Study Site 15
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Study Site 43
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Study Site 52
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92692
Country
United States
Facility Name
Study Site 20
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Study Site 28
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Study Site 25
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Study Site 36
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Study Site 48
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Study Site 68
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Study Site 59
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Study Site 12
City
Largo
State/Province
Florida
ZIP/Postal Code
33778
Country
United States
Facility Name
Study Site 62
City
Miami
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Study Site 57
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Study Site 33
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Study Site 11
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Study Site 60
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Study Site 39
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Study Site 34
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Study Site 42
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Study Site 41
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Study Site 37
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Study Site 27
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Study Site 16
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Study Site 32
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Study Site 55
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Study Site 24
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Study Site 53
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Study Site 50
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Study Site 54
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Study Site 73
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Study Site 71
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Study Site 56
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Study Site 74
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Study Site 26
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Study Site 38
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Study Site 21
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Study Site 72
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Study Site 22
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Study Site 35
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Study Site 10
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Study Site 49
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Study Site 23
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Study Site 58
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Study Site 19
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Study Site 14
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Study Site 13
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Study Site 66
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
Study Site 65
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Study Site 64
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Study Site 29
City
Romford
State/Province
Essex
ZIP/Postal Code
RM1 3PJ
Country
United Kingdom
Facility Name
Study Site 94
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
Study Site 93
City
Prescot
State/Province
Merseyside
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Facility Name
Study Site 17
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Study Site 40
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Study Site 96
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 3DL
Country
United Kingdom
Facility Name
Study Site 97
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Facility Name
Study Site 95
City
Stockton-on-Tees
State/Province
Teesside
ZIP/Postal Code
TS17 6EW
Country
United Kingdom
Facility Name
Study Site 45
City
Hull
Country
United Kingdom
Facility Name
Study Site 92
City
Leeds
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Facility Name
Study Site 30
City
Leicester
Country
United Kingdom
Facility Name
Study Site 46
City
London
Country
United Kingdom
Facility Name
Study Site 91
City
Manchester
ZIP/Postal Code
M32 0UT
Country
United Kingdom
Facility Name
Study Site 18
City
Manchester
Country
United Kingdom
Facility Name
Study Site 47
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Study Site 31
City
North Shields
Country
United Kingdom
Facility Name
Study Site44
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

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