| Primary | Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS) | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| | Units | Counts |
|---|
| Participants | - OG00039
- OG00139
- OG00239
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.69± 1.583
- OG001-0.66± 1.276
- OG002-0.26± 1.155
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.989 | | Mean Difference (Final Values) | 0.00 | Standard Error of the Mean | 0.305 | 2-Sided | 95 | -0.62 | 0.63 | | | | | Superiority | | | | | ANCOVA | | 0.054 |
|
| Secondary | Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity first thing in the morning | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale | A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for severity of any other coughing during the last 24 hours, excluding coughing first thing in the morning | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale | A numerical rating scale from 0 (no urge to cough) to 10 (urge to cough as bad as you can imagine) for severity of urge to cough in the last 24 hours | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale | A 5-point verbal rating scale for cough frequency over the last 24 hours with response options from 'never' to 'all the time'. The verbal responses were converted to a number (0 = never, 4 = all the time). | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale | A numerical rating scale from 0 (no shortness of breath) to 10 (shortness of breath as bad as you can imagine) for severity of shortness of breath in the last 24 hours | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the total score. | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
|
| Secondary | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the physical domain score. | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
|
| Secondary | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the psychological domain score. | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
|
| Secondary | Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score | The LCQ is a 19-item questionnaire that assesses cough-related Quality-of-Life. It has three domains (physical, psychological and social). The total score range is 3-21 and domain scores each range from 1-7; a higher score indicates a better Quality-of-Life. This outcome measure is the mean change from Baseline to Week 4 in the social domain score. | | Posted | | Mean | Standard Deviation | Points | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
|
| Secondary | Mean Change From Baseline in 24-hour Cough Frequency | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) | Fewer participants analyzed than assigned to the groups as some had insufficient recordings. | Posted | | Geometric Least Squares Mean | Standard Error | Coughs/hour ratio vs baseline | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Awake Cough Frequency | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) | Fewer participants analyzed than assigned to the groups as some had insufficient recordings. | Posted | | Geometric Least Squares Mean | Standard Error | Awake coughs/hour ratio vs baseline | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in Night-time Cough Frequency | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) | Fewer participants analyzed than assigned to the groups as some had insufficient recordings. | Posted | | Geometric Least Squares Mean | Standard Error | Asleep coughs/hour ratio vs baseline | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in the Number of Coughing Bouts | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) | Fewer participants analyzed than assigned to the groups as some had insufficient recordings. | Posted | | Geometric Least Squares Mean | Standard Error | Bouts/hour ratio vs baseline | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |
| Secondary | Mean Change From Baseline in the Number of Coughs Per Bout | Cough frequency assessed using an ambulatory cough monitoring device (Leicester Cough Monitor) | Fewer participants analyzed than assigned to the groups as some had insufficient recordings. | Posted | | Geometric Least Squares Mean | Standard Error | Coughs per bout ratio vs baseline | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo (10 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 10mg cohort) | | OG001 | Orvepitant 10 mg | Orvepitant 10 mg once-daily for 4 weeks in either Period A or Period B | | OG002 | Placebo (30 mg Cohort) | Placebo once-daily for 4 weeks in either Period A or Period B (subjects assigned to orvepitant 30mg cohort) | | OG003 | Orvepitant 30 mg | Orvepitant 30 mg once-daily for 4 weeks in either Period A or Period B |
| |