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A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
Phase 2 trial testing Orvepitant Maleate in Chronic Refractory Cough in 315 participants. Completed in 24 January 2019.
| Lead sponsor | Nerre Therapeutics Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 315 |
| Start date | 22 May 2017 |
| Primary completion | 14 January 2019 |
| Estimated completion | 24 January 2019 |
| Sites | 66 locations across United Kingdom, Canada, United States |
Nerre Therapeutics Ltd. — full company profile →
18 and older, any sex, with Chronic Refractory Cough. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective cough frequency measured by ambulatory cough monitoring device
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -0.185 | ± 0.3258 |
| Orvepitant 20mg | -0.192 | ± 0.3405 |
| Orvepitant 30mg | -0.271 | ± 0.4055 |
| Placebo | -0.243 | ± 0.3225 |
Objective cough frequency measured by ambulatory cough monitoring device
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -0.180 | ± 0.2791 |
| Orvepitant 20mg | -0.181 | ± 0.3142 |
| Orvepitant 30mg | -0.215 | ± 0.2515 |
| Placebo | -0.139 | ± 0.2892 |
Objective cough frequency measured by ambulatory cough monitoring device
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -0.188 | ± 0.3292 |
| Orvepitant 20mg | -0.231 | ± 0.3665 |
| Orvepitant 30mg | -0.211 | ± 0.2994 |
| Placebo | -0.169 | ± 0.2699 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | 2.41 | ± 3.309 |
| Orvepitant 20mg | 2.37 | ± 3.252 |
| Orvepitant 30mg | 2.93 | ± 3.010 |
| Placebo | 1.24 | ± 2.714 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | 2.50 | ± 3.416 |
| Orvepitant 20mg | 2.15 | ± 3.490 |
| Orvepitant 30mg | 2.98 | ± 3.163 |
| Placebo | 1.61 | ± 3.132 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | 2.78 | ± 3.535 |
| Orvepitant 20mg | 2.19 | ± 3.602 |
| Orvepitant 30mg | 2.82 | ± 3.960 |
| Placebo | 1.34 | ± 3.222 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | 2.38 | ± 3.609 |
| Orvepitant 20mg | 2.09 | ± 3.736 |
| Orvepitant 30mg | 3.23 | ± 4.007 |
| Placebo | 1.50 | ± 3.586 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -17.7 | ± 26.06 |
| Orvepitant 20mg | -10.5 | ± 27.78 |
| Orvepitant 30mg | -13.5 | ± 22.93 |
| Placebo | -6.3 | ± 19.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -17.9 | ± 27.11 |
| Orvepitant 20mg | -9.4 | ± 26.76 |
| Orvepitant 30mg | -15.9 | ± 25.02 |
| Placebo | -7.8 | ± 22.36 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -21.0 | ± 30.37 |
| Orvepitant 20mg | -9.9 | ± 29.57 |
| Orvepitant 30mg | -18.6 | ± 27.24 |
| Placebo | -8.2 | ± 23.58 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -18.8 | ± 31.27 |
| Orvepitant 20mg | -11.6 | ± 27.33 |
| Orvepitant 30mg | -20.1 | ± 29.33 |
| Placebo | -10.6 | ± 24.46 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Orvepitant 10mg | -12.8 | ± 28.96 |
| Orvepitant 20mg | -7.8 | ± 26.76 |
| Orvepitant 30mg | -6.2 | ± 24.97 |
| Placebo | -3.9 | ± 27.62 |
Time frame: Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|---|
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Suicide attempt | Psychiatric disorders | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Reaction | System | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Somnolence | Nervous system disorders | — | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
Most-reported serious reactions: Intestinal anastomosis complication, Hypertension, Bradycardia, Invasive ductal breast carcinoma, Suicide attempt, Anxiety, Dehydration.
Data from ClinicalTrials.gov NCT02993822 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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