Phase 2
N=315
A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
Chronic Refractory Cough
Bottom Line
View on ClinicalTrials.gov: NCT02993822 ↗Enrolled (actual)
315
Serious AEs
1.9%
Results posted
Apr 2022
Primary outcome: Primary: Change From Baseline to Week 12 in Awake Objective Cough Frequency — -0.185; -0.192; -0.271; -0.243 coughs per hour (log transformed) — p=0.324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Orvepitant Maleate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nerre Therapeutics Ltd.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Awake Objective Cough Frequency |
-0.185; -0.192; -0.271; -0.243 | 0.324 |
| SECONDARY Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline |
-0.180; -0.181; -0.215; -0.139 | 0.482 |
| SECONDARY Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline |
-0.188; -0.231; -0.211; -0.169 | 0.992 |
| SECONDARY Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline |
2.41; 2.37; 2.93; 1.24 | 0.042 sig |
| SECONDARY Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline |
2.50; 2.15; 2.98; 1.61 | 0.250 |
| SECONDARY Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline |
2.78; 2.19; 2.82; 1.34 | 0.038 sig |
| SECONDARY Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline |
2.38; 2.09; 3.23; 1.50 | 0.258 |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time |
-17.7; -10.5; -13.5; -6.3 | 0.008 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time |
-17.9; -9.4; -15.9; -7.8 | 0.026 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time |
-21.0; -9.9; -18.6; -8.2 | 0.006 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time |
-18.8; -11.6; -20.1; -10.6 | 0.103 |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time |
-12.8; -7.8; -6.2; -3.9 | 0.004 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time |
-10.1; -7.9; -5.8; -2.7 | 0.019 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time |
-11.5; -6.8; -9.8; -2.2 | 0.006 sig |
| SECONDARY Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time |
-8.9; -7.1; -9.6; -1.5 | 0.027 sig |
| SECONDARY Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline |
-20.8; -12.0; -13.8; -7.0 | <0.001 sig |
| SECONDARY Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline |
-19.0; -12.0; -17.3; -8.8 | 0.027 sig |
| SECONDARY Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline |
-23.8; -14.5; -19.7; -11.0 | 0.008 sig |
| SECONDARY Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline |
-23.7; -12.6; -22.9; -11.8 | 0.018 sig |
| SECONDARY Global Rating of Change in Cough Frequency at Week 2 |
4; 10; 5; 11; 35; 37 | 0.004 sig |
| SECONDARY Global Rating of Change in Cough Frequency at Week 4 |
9; 8; 6; 12; 32; 36 | 0.401 |
| SECONDARY Global Rating of Change in Cough Frequency at Week 8 |
11; 17; 10; 20; 22; 31 | 0.002 sig |
| SECONDARY Global Rating of Change in Cough Frequency at Week 12 |
7; 13; 7; 13; 32; 33 | 0.158 |
| SECONDARY Global Rating of Change in Cough Severity at Week 2 |
7; 8; 4; 12; 33; 39 | 0.01 sig |
| SECONDARY Global Rating of Change in Cough Severity at Week 4 |
9; 7; 7; 14; 32; 43 | 0.309 |
| SECONDARY Global Rating of Change in Cough Severity at Week 8 |
8; 12; 6; 15; 26; 36 | 0.003 sig |
| SECONDARY Global Rating of Change in Cough Severity at Week 12 |
5; 15; 8; 16; 38; 33 | 0.100 |
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.
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT02993822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.