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

NeRRe Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Refractory Cough

Treatments: Drug: Placebo; Drug: Orvepitant Maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02993822

VOLCANO-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 4 patient groups, including a placebo group

Orvepitant 10mg

Experimental group

Description:

Orvepitant 10mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant Maleate

Orvepitant 20mg

Experimental group

Description:

Orvepitant 20mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant Maleate

Orvepitant 30mg

Experimental group

Description:

Orvepitant 30mg tablet, once daily for 12 weeks

Treatment:

Drug: Orvepitant Maleate

Placebo

Placebo Comparator group

Description:

Placebo to match tablet, once daily for 12 weeks

Treatment:

Drug: Placebo