Trial Outcomes & Findings for A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT04647383)
NCT ID: NCT04647383
Last Updated: 2023-10-10
Results Overview
AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour \[min/hour\]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (\>=) 5 to less than (\<) 15 is classed as mild, AHI \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG).
COMPLETED
PHASE1
63 participants
Day 8 of Treatment Periods 1 and 2 (up to Day 30)
2023-10-10
Participant Flow
Participants took part in the study at 10 investigative sites in the United States from 06 January 2021 to 10 February 2022.
A total of 48 participants for the obstructive sleep apnea (OSA) cohort were screened, of which 15 were screen failures and 33 were randomized in OSA cohort to receive study treatment. A total of 108 participants were screened for the chronic obstructive pulmonary disease (COPD) cohort, of which 78 were screen failures and 30 were randomized in COPD cohort to receive study treatment.
Participant milestones
| Measure |
OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 milligram (mg) tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg
Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|---|---|
|
Treatment Period 1 (8 Days)
STARTED
|
16
|
17
|
14
|
16
|
|
Treatment Period 1 (8 Days)
COMPLETED
|
16
|
17
|
14
|
16
|
|
Treatment Period 1 (8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (14 Days)
STARTED
|
16
|
17
|
14
|
16
|
|
Washout Period (14 Days)
COMPLETED
|
16
|
17
|
14
|
16
|
|
Washout Period (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (8 Days)
STARTED
|
16
|
17
|
14
|
16
|
|
Treatment Period 2 (8 Days)
COMPLETED
|
16
|
16
|
14
|
16
|
|
Treatment Period 2 (8 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 milligram (mg) tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg
Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|---|---|
|
Treatment Period 2 (8 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg
n=16 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo
n=17 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg
n=14 Participants
Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
n=16 Participants
Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The pharmacodynamic (PD) analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour \[min/hour\]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (\>=) 5 to less than (\<) 15 is classed as mild, AHI \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG).
Outcome measures
| Measure |
OSA Cohort: Placebo
n=32 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2
|
45.09 events (apnea plus hyponea) per hour
Standard Deviation 22.851
|
44.90 events (apnea plus hyponea) per hour
Standard Deviation 22.246
|
PRIMARY outcome
Timeframe: Day 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2
|
90.80 percentage of oxygen saturation
Standard Deviation 2.565
|
91.27 percentage of oxygen saturation
Standard Deviation 2.227
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1 and 2 (up to Day 23)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=33 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2
|
44.65 events (apnea plus hyponea) per hour
Standard Deviation 25.770
|
41.64 events (apnea plus hyponea) per hour
Standard Deviation 21.215
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=33 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
93.12 percentage of oxygen saturation
Standard Deviation 2.073
|
93.00 percentage of oxygen saturation
Standard Deviation 2.462
|
|
OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
93.44 percentage of oxygen saturation
Standard Deviation 1.983
|
93.06 percentage of oxygen saturation
Standard Deviation 1.983
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure.
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=33 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <90%
|
11.966 percentage of TST
Standard Deviation 16.8941
|
12.849 percentage of TST
Standard Deviation 15.5993
|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <85%
|
2.708 percentage of TST
Standard Deviation 4.9400
|
3.748 percentage of TST
Standard Deviation 6.6010
|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <80%
|
0.776 percentage of TST
Standard Deviation 1.7896
|
1.125 percentage of TST
Standard Deviation 2.5021
|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <90%
|
9.474 percentage of TST
Standard Deviation 9.7930
|
11.295 percentage of TST
Standard Deviation 12.6345
|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <85%
|
2.283 percentage of TST
Standard Deviation 3.6302
|
2.696 percentage of TST
Standard Deviation 4.4283
|
|
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <80%
|
0.522 percentage of TST
Standard Deviation 1.3345
|
0.651 percentage of TST
Standard Deviation 1.3153
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure.
ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=33 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
39.71 events per hour
Standard Deviation 24.547
|
36.52 events per hour
Standard Deviation 20.325
|
|
OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
39.07 events per hour
Standard Deviation 21.475
|
39.51 events per hour
Standard Deviation 22.037
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure.
Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=33 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
253.85 events (number of desaturations)
Standard Deviation 161.971
|
256.52 events (number of desaturations)
Standard Deviation 141.952
|
|
OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
255.28 events (number of desaturations)
Standard Deviation 149.158
|
273.97 events (number of desaturations)
Standard Deviation 155.209
|
SECONDARY outcome
Timeframe: Day 1 of Treatment Periods 1 and 2 (up to Day 23)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2
|
91.53 percentage of oxygen saturation
Standard Deviation 2.161
|
91.13 percentage of oxygen saturation
Standard Deviation 2.801
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
6.09 events (apnea plus hyponea) per hour
Standard Deviation 4.827
|
7.40 events (apnea plus hyponea) per hour
Standard Deviation 6.331
|
|
COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
5.88 events (apnea plus hyponea) per hour
Standard Deviation 5.245
|
6.15 events (apnea plus hyponea) per hour
Standard Deviation 5.185
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <80%
|
0.152 percentage of TST
Standard Deviation 0.4743
|
0.075 percentage of TST
Standard Deviation 0.2218
|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <90%
|
15.593 percentage of TST
Standard Deviation 23.3552
|
21.468 percentage of TST
Standard Deviation 30.0042
|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <85%
|
0.860 percentage of TST
Standard Deviation 1.9286
|
3.286 percentage of TST
Standard Deviation 9.0190
|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 1: SpO2 <80%
|
0.155 percentage of TST
Standard Deviation 0.5416
|
0.224 percentage of TST
Standard Deviation 0.5912
|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <90%
|
22.991 percentage of TST
Standard Deviation 30.9595
|
21.086 percentage of TST
Standard Deviation 30.3560
|
|
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
Day 8: SpO2 <85%
|
3.330 percentage of TST
Standard Deviation 9.9935
|
1.151 percentage of TST
Standard Deviation 3.1124
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
4.61 events per hour
Standard Deviation 4.462
|
5.46 events per hour
Standard Deviation 4.823
|
|
COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
4.34 events per hour
Standard Deviation 4.562
|
4.71 events per hour
Standard Deviation 4.772
|
SECONDARY outcome
Timeframe: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)Population: The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter.
Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=30 Participants
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=30 Participants
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|
|
COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
Day 1
|
26.77 events (number of desaturations)
Standard Deviation 27.485
|
36.07 events (number of desaturations)
Standard Deviation 31.509
|
|
COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
Day 8
|
25.33 events (number of desaturations)
Standard Deviation 28.243
|
29.97 events (number of desaturations)
Standard Deviation 33.055
|
Adverse Events
OSA Cohort: Placebo
OSA Cohort: Lemborexant 10 mg
COPD Cohort: Placebo
COPD Cohort: Lemborexant 10 mg
Serious adverse events
| Measure |
OSA Cohort: Placebo
n=33 participants at risk
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 participants at risk
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort: Placebo
n=30 participants at risk
Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort: Lemborexant 10 mg
n=30 participants at risk
Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|---|---|
|
Investigations
SARS-CoV-2 test positive
|
3.0%
1/33 • Number of events 1 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
3.3%
1/30 • Number of events 1 • Baseline up to end of follow up visit (up to 59 days)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
3.3%
1/30 • Number of events 1 • Baseline up to end of follow up visit (up to 59 days)
|
Other adverse events
| Measure |
OSA Cohort: Placebo
n=33 participants at risk
Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
OSA Cohort: Lemborexant 10 mg
n=33 participants at risk
Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort: Placebo
n=30 participants at risk
Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
COPD Cohort: Lemborexant 10 mg
n=30 participants at risk
Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods.
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
6.1%
2/33 • Number of events 2 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/30 • Baseline up to end of follow up visit (up to 59 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
0.00%
0/33 • Baseline up to end of follow up visit (up to 59 days)
|
6.7%
2/30 • Number of events 2 • Baseline up to end of follow up visit (up to 59 days)
|
3.3%
1/30 • Number of events 1 • Baseline up to end of follow up visit (up to 59 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place