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

NCT02993822 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VOLCANO-2
• Study Type: interventional
• Target: 315
• Locations: 3 countries
• Sites: 66

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.

Conditions

Chronic Refractory Cough

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in Awake Objective Cough Frequency

  Objective cough frequency measured by ambulatory cough monitoring device

  Baseline to Week 12

Secondary Outcomes (26)

• Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline

  Baseline to Week 2

• Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline

  Week 4

• Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline

  Baseline to Week 2

• Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline

  Baseline to Week 4

• Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline

  Baseline to Week 8

Study Arms (4)

Orvepitant 10mg

EXPERIMENTAL

Orvepitant 10mg tablet, once daily for 12 weeks

Drug: Orvepitant Maleate

Orvepitant 20mg

EXPERIMENTAL

Orvepitant 20mg tablet, once daily for 12 weeks

Drug: Orvepitant Maleate

Orvepitant 30mg

EXPERIMENTAL

Orvepitant 30mg tablet, once daily for 12 weeks

Drug: Orvepitant Maleate

Placebo

PLACEBO COMPARATOR

Placebo to match tablet, once daily for 12 weeks

Drug: Placebo

Interventions

Orvepitant Maleate DRUG

Tablet, once daily, oral

Orvepitant 10mg; Orvepitant 20mg; Orvepitant 30mg

Placebo DRUG

Tablet, once daily, oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nerre Therapeutics Ltd.: lead

Study Sites (66)

Study Site 15

Chandler, Arizona, 85224, United States

Location

Study Site 43

Los Angeles, California, 90025, United States

Location

Study Site 52

Mission Viejo, California, 92692, United States

Location

Study Site 20

San Diego, California, 92108, United States

Location

Study Site 28

San Jose, California, 95117, United States

Location

Study Site 25

Centennial, Colorado, 80112, United States

Location

Study Site 36

Colorado Springs, Colorado, 80907, United States

Location

Study Site 48

Waterbury, Connecticut, 06708, United States

Location

Study Site 68

Clearwater, Florida, 33765, United States

Location

Study Site 59

Jacksonville, Florida, 32224, United States

Location

Study Site 12

Largo, Florida, 33778, United States

Location

Study Site 62

Miami, Florida, 33060, United States

Location

Study Site 57

Miami, Florida, 33186, United States

Location

Study Site 33

Tampa, Florida, 33613, United States

Location

Study Site 11

Winter Park, Florida, 32789, United States

Location

Study Site 60

Meridian, Idaho, 83642, United States

Location

Study Site 39

Normal, Illinois, 61761, United States

Location

Study Site 34

Baltimore, Maryland, 21236, United States

Location

Study Site 42

Edina, Minnesota, 55435, United States

Location

Study Site 41

Minneapolis, Minnesota, 55402, United States

Location

Study Site 37

Rochester, Minnesota, 55905, United States

Location

Study Site 27

Missoula, Montana, 59808, United States

Location

Study Site 16

Las Vegas, Nevada, 89128, United States

Location

Study Site 32

Rochester, New York, 14618, United States

Location

Study Site 55

Charlotte, North Carolina, 28204, United States

Location

Study Site 24

Charlotte, North Carolina, 28207, United States

Location

Study Site 53

Charlotte, North Carolina, 29732, United States

Location

Study Site 50

Gastonia, North Carolina, 28054, United States

Location

Study Site 54

Greensboro, North Carolina, 27403, United States

Location

Study Site 73

Mooresville, North Carolina, 28117, United States

Location

Study Site 71

Raleigh, North Carolina, 27612, United States

Location

Study Site 56

Cincinnati, Ohio, 45231, United States

Location

Study Site 74

Oklahoma City, Oklahoma, 73131, United States

Location

Study Site 26

Tulsa, Oklahoma, 74136, United States

Location

Study Site 38

East Providence, Rhode Island, 02914, United States

Location

Study Site 21

Charleston, South Carolina, 29420, United States

Location

Study Site 72

Charleston, South Carolina, 29464, United States

Location

Study Site 22

Dallas, Texas, 75231, United States

Location

Study Site 35

Dallas, Texas, 75231, United States

Location

Study Site 10

Houston, Texas, 77074, United States

Location

Study Site 49

San Antonio, Texas, 78229, United States

Location

Study Site 23

Waco, Texas, 76712, United States

Location

Study Site 58

Salt Lake City, Utah, 84108, United States

Location

Study Site 19

Charlottesville, Virginia, 22911, United States

Location

Study Site 14

Bellingham, Washington, 98225, United States

Location

Study Site 13

Greenfield, Wisconsin, 53228, United States

Location

Study Site 66

Niagara Falls, Ontario, L2G 1J4, Canada

Location

Study Site 65

Québec, Quebec, G1V 4W2, Canada

Location

Study Site 64

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Study Site 29

Romford, Essex, RM1 3PJ, United Kingdom

Location

Study Site 94

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

Study Site 93

Prescot, Merseyside, L34 1BH, United Kingdom

Location

Study Site 17

Northwood, Middlesex, United Kingdom

Location

Study Site 40

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Study Site 96

Barnsley, South Yorkshire, S75 3DL, United Kingdom

Location

Study Site 97

Cannock, Staffordshire, WS11 0BN, United Kingdom

Location

Study Site 95

Stockton-on-Tees, Teesside, TS17 6EW, United Kingdom

Location

Study Site 45

Hull, United Kingdom

Location

Study Site 92

Leeds, LS10 1DU, United Kingdom

Location

Study Site 30

Leicester, United Kingdom

Location

Study Site 46

London, United Kingdom

Location

Study Site 91

Manchester, M32 0UT, United Kingdom

Location

Study Site 18

Manchester, United Kingdom

Location

Study Site 47

Newcastle upon Tyne, United Kingdom

Location

Study Site 31

North Shields, United Kingdom

Location

Study Site44

Oxford, United Kingdom

Location

Results Point of Contact

• Title: Dr. Stephen Pawsey
• Organization: NeRRe Therapeutics Limited

steve.pawsey@nerretherapeutics.com

+44 (0)1438906960

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 15, 2016
• Study Start: May 22, 2017
• Primary Completion: January 14, 2019
• Study Completion: January 24, 2019
• Last Updated: April 26, 2022
• Results First Posted: April 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (46); GB (17)