Trial Outcomes & Findings for To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep. (NCT NCT03105297)
NCT ID: NCT03105297
Last Updated: 2019-07-26
Results Overview
Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights \[on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively\], of the nasal resistance phase.
COMPLETED
PHASE2
91 participants
upto 2 days
2019-07-26
Participant Flow
Participants were recruited from one center in Australia.
103 participants were screened, out of which 9 were screening failure, 3 did not want to participate. Remaining 91 participants were included in the safety population.
Participant milestones
| Measure |
All Participants
The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule
|
|---|---|
|
Baseline Phase (Day 1)
STARTED
|
91
|
|
Baseline Phase (Day 1)
COMPLETED
|
70
|
|
Baseline Phase (Day 1)
NOT COMPLETED
|
21
|
|
Active Phase (Day 2-29)
STARTED
|
70
|
|
Active Phase (Day 2-29)
COMPLETED
|
70
|
|
Active Phase (Day 2-29)
NOT COMPLETED
|
0
|
|
Nasal Resistance Phase (Day 30, 31)
STARTED
|
56
|
|
Nasal Resistance Phase (Day 30, 31)
Treated
|
55
|
|
Nasal Resistance Phase (Day 30, 31)
COMPLETED
|
48
|
|
Nasal Resistance Phase (Day 30, 31)
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
All Participants
The study consisted of 3 phases: baseline phase, 28 days active phase followed by a two-night cross-over nasal resistance phase. In the baseline phase all the participants applied nasal dilator strip during the sleep laboratory night on Day 1. During the active phase participants wore nasal dilator strip over a 1-month in-home use period and returned for sleep laboratory nights after 7 days (on Day 8) and 28 days (on Day 29) of treatment. The nasal resistance phase consisted of 2 sleep laboratory nights (Day 30 and 31), where the participants were randomized to receive a sequence of either 'strip'/' no strip' or no strip'/'strip' as per the randomization schedule
|
|---|---|
|
Baseline Phase (Day 1)
Other
|
21
|
|
Nasal Resistance Phase (Day 30, 31)
Adverse Event
|
1
|
|
Nasal Resistance Phase (Day 30, 31)
Withdrawal by Subject
|
7
|
Baseline Characteristics
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
Baseline characteristics by cohort
| Measure |
All Participants
n=91 Participants
All participants to whom the study treatment was dispensed were considered evaluable for baseline characteristics
|
|---|---|
|
Age, Continuous
|
48.8 Years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: upto 2 daysPopulation: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number of participants analyzed "N" signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories.
Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights \[on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively\], of the nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=55 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Nasal Resistance in Sleeping State : Nasal Resistance Phase
Without strip (Day 30 and 31)
|
2.658 Centimeter (cm) H2O/liter/sec
Standard Deviation 2.4469
|
|
Nasal Resistance in Sleeping State : Nasal Resistance Phase
With strip (Day 30 and 31)
|
2.202 Centimeter (cm) H2O/liter/sec
Standard Deviation 2.5819
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure.
Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Before strip application
|
1.949 cm^2
Standard Deviation 0.8520
|
|
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
After strip application
|
2.535 cm^2
Standard Deviation 0.8735
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure.
Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Before strip application
|
4.145 cm^3
Standard Deviation 1.2013
|
|
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
After strip application
|
5.043 cm^3
Standard Deviation 1.4038
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population included all participants to whom the study treatment was dispensed. Here, "N" signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories.
Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
Before strip application
|
4.468 cmH2O/liter/seconds
Standard Deviation 4.7625
|
|
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
After strip application
|
3.251 cmH2O/liter/seconds
Standard Deviation 4.1677
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, "N" signifies participants who were evaluable for this outcome measure.
The FOSQ was 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life (QoL). The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score each question of FOSQ which then grouped in above factors (where 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, moderate difficulty, 3= Yes, a little difficulty, and 4= No difficulty). Total score of composite FOSQ was the sum of scores obtained on all 30 questions of the questionnaire. The possible range for the total score of composite FOSQ was from 0-120. A higher total score of composite FOSQ indicates better QoL of the participant.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=61 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
|
17.55 Score on a scale
Standard Deviation 2.129
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable for the specified categories.
On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved (higher score indicated improvement).
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Global Self Assessment Score : Active Phase
Ease of breathing
|
1.4 Score on a scale
Standard Deviation 0.68
|
|
Global Self Assessment Score : Active Phase
Falling asleep
|
0.6 Score on a scale
Standard Deviation 0.78
|
|
Global Self Assessment Score : Active Phase
Staying asleep
|
0.8 Score on a scale
Standard Deviation 0.76
|
|
Global Self Assessment Score : Active Phase
Number of awakenings
|
0.7 Score on a scale
Standard Deviation 0.77
|
|
Global Self Assessment Score : Active Phase
Falling back to sleep
|
0.7 Score on a scale
Standard Deviation 0.76
|
|
Global Self Assessment Score : Active Phase
Waking up too early
|
0.3 Score on a scale
Standard Deviation 0.63
|
|
Global Self Assessment Score : Active Phase
Sleep depth
|
0.7 Score on a scale
Standard Deviation 0.70
|
|
Global Self Assessment Score : Active Phase
Sleep quality
|
0.9 Score on a scale
Standard Deviation 0.69
|
|
Global Self Assessment Score : Active Phase
Nocturia (waking up to urinate)
|
0.3 Score on a scale
Standard Deviation 0.60
|
|
Global Self Assessment Score : Active Phase
Dry mouth upon awakening
|
0.6 Score on a scale
Standard Deviation 0.82
|
|
Global Self Assessment Score : Active Phase
Morning headache
|
0.4 Score on a scale
Standard Deviation 0.67
|
|
Global Self Assessment Score : Active Phase
Feeling refreshed in the morning
|
0.8 Score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Day 29Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, "N" signifies participants who were evaluable for this outcome measure.
Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. Total ESS was calculated as the sum of all the individual scores observed for the above mentioned situations. The possible range for total ESS was 0-24. A lower total ESS indicates better sleep.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=61 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Total Epworth Sleepiness Scale Score (ESS) : Active Phase
|
7.410 Score on scale
Standard Deviation 4.6021
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints
The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Day 1
|
308.18 Number of snores per hour
Standard Deviation 216.829
|
|
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Day 8
|
299.58 Number of snores per hour
Standard Deviation 204.598
|
|
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Day 29
|
330.30 Number of snores per hour
Standard Deviation 233.635
|
|
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
317.76 Number of snores per hour
Standard Deviation 208.098
|
|
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
324.92 Number of snores per hour
Standard Deviation 190.559
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 1
|
40.33 Percentage of sleep time
Standard Deviation 27.444
|
|
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 8
|
38.70 Percentage of sleep time
Standard Deviation 25.826
|
|
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 29
|
42.41 Percentage of sleep time
Standard Deviation 28.974
|
|
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
42.11 Percentage of sleep time
Standard Deviation 27.167
|
|
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
43.22 Percentage of sleep time
Standard Deviation 24.704
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 1
|
40.67 Decibels
Standard Deviation 6.278
|
|
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 8
|
41.85 Decibels
Standard Deviation 6.365
|
|
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 29
|
44.14 Decibels
Standard Deviation 6.730
|
|
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
43.10 Decibels
Standard Deviation 4.780
|
|
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
43.89 Decibels
Standard Deviation 4.628
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints
The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 1
|
67.84 Decibels
Standard Deviation 9.944
|
|
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 8
|
66.44 Decibels
Standard Deviation 8.854
|
|
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Day 29
|
69.87 Decibels
Standard Deviation 8.876
|
|
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
69.48 Decibels
Standard Deviation 13.525
|
|
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
70.28 Decibels
Standard Deviation 11.917
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 1
|
26.38 Percentage of participants
Standard Deviation 27.322
|
|
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 8
|
27.78 Percentage of participants
Standard Deviation 28.200
|
|
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 29
|
31.25 Percentage of participants
Standard Deviation 29.558
|
|
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
44.71 Percentage of participants
Standard Deviation 31.139
|
|
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
48.40 Percentage of participants
Standard Deviation 28.899
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
The Investigator or designee recorded the oro-nasal breathing route during the participant's domiciled sleep visits. Oro-nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 1
|
70.92 Percentage of participants
Standard Deviation 29.496
|
|
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 8
|
70.26 Percentage of participants
Standard Deviation 28.578
|
|
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Day 29
|
64.44 Percentage of participants
Standard Deviation 32.627
|
|
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
51.04 Percentage of participants
Standard Deviation 29.894
|
|
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
47.60 Percentage of participants
Standard Deviation 28.508
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
TST was measured by overnight polysomnography (PSG) using a computerized system. TST was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Day 1
|
369.54 Minutes
Standard Deviation 52.629
|
|
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Day 8
|
371.97 Minutes
Standard Deviation 58.359
|
|
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Day 29
|
366.26 Minutes
Standard Deviation 69.722
|
|
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
317.98 Minutes
Standard Deviation 91.910
|
|
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
304.65 Minutes
Standard Deviation 101.447
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Sleep efficiency \[SE, a polysomnography (PSG)\] was measured as the percentage of total time in bed spent in sleep. It was calculated as the sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. SE gives an overall sense of how well the participant slept and was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Day 29
|
82.25 Percentage of sleep time
Standard Deviation 11.607
|
|
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Day 1
|
80.50 Percentage of sleep time
Standard Deviation 10.631
|
|
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Day 8
|
81.66 Percentage of sleep time
Standard Deviation 10.184
|
|
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
75.56 Percentage of sleep time
Standard Deviation 16.095
|
|
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
73.63 Percentage of sleep time
Standard Deviation 19.130
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Sleep onset latency (SOL, a PSG parameter) was measured as the duration from the time when lights were turned off (as the participants attempted to sleep) till the time participant fell asleep. Determination of sleep and awake state was based on Electroencephalography (EEG) and behavioral parameters change. SOL was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Day 1
|
13.86 Minutes
Standard Deviation 18.469
|
|
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Day 8
|
14.92 Minutes
Standard Deviation 17.275
|
|
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Day 29
|
9.69 Minutes
Standard Deviation 8.877
|
|
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
14.29 Minutes
Standard Deviation 19.943
|
|
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
18.45 Minutes
Standard Deviation 23.937
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Arousal index (AI) is the number of arousals and awakenings, reported as a total number per hour of sleep. AI was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Day 1
|
25.12 Number of arousals per hour
Standard Deviation 11.308
|
|
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Day 8
|
25.24 Number of arousals per hour
Standard Deviation 10.979
|
|
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Day 29
|
25.97 Number of arousals per hour
Standard Deviation 12.916
|
|
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
35.33 Number of arousals per hour
Standard Deviation 17.250
|
|
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
38.33 Number of arousals per hour
Standard Deviation 20.908
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Non-Rapid eye movement (NREM) sleep stage consist of 3 progressively deeper stages of sleep: N1 (transition period from being awake to falling asleep), N2 (where breathing and heart rate began to slow) and N3 (slow wave sleep where body heals and repair itself). Sleep architecture (SA) was measured by the percentage of sleep time spent by the participants in each stage (time spent in each stage to total time spent in NREM, multiplied by 100). SA was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N1: With strip (Day 29 and 30)
|
8.82 Percentage of sleep time
Standard Deviation 11.567
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N1: Day 1
|
8.30 Percentage of sleep time
Standard Deviation 4.123
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N1: Day 8
|
7.58 Percentage of sleep time
Standard Deviation 4.140
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N1: Day 29
|
8.46 Percentage of sleep time
Standard Deviation 5.468
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N1: Without strip (Day 29 and 30)
|
7.65 Percentage of sleep time
Standard Deviation 6.896
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N2: Day 1
|
47.93 Percentage of sleep time
Standard Deviation 6.881
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N2: Day 8
|
48.00 Percentage of sleep time
Standard Deviation 7.876
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N2: Day 29
|
47.12 Percentage of sleep time
Standard Deviation 6.558
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N2: Without strip (Day 29 and 30)
|
55.41 Percentage of sleep time
Standard Deviation 8.129
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N2: With strip (Day 29 and 30)
|
54.71 Percentage of sleep time
Standard Deviation 10.212
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N3: Day 1
|
22.83 Percentage of sleep time
Standard Deviation 7.249
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N3: Day 8
|
22.14 Percentage of sleep time
Standard Deviation 7.060
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N3 at Day 29
|
22.38 Percentage of sleep time
Standard Deviation 6.779
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N3: Without strip (Day 29 and 30)
|
19.02 Percentage of sleep time
Standard Deviation 8.255
|
|
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
% N3: With strip (Day 29 and 30)
|
18.37 Percentage of sleep time
Standard Deviation 9.654
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Total NREM (N1, 2, and 3) and REM sleep were calculated as the time spent by a participant in the NREM (measured during stable sleep) and REM sleep stages. Total NREM and REM sleep was measured by overnight PSG using a computerized system for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
NREM: Day 1
|
296.30 Minutes
Standard Deviation 41.046
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
NREM: Day 8
|
294.17 Minutes
Standard Deviation 46.660
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
NREM: Day 29
|
289.48 Minutes
Standard Deviation 52.366
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
NREM: Without strip (Day 30 and 31)
|
264.82 Minutes
Standard Deviation 79.545
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
NREM: With strip (Day 30 and 31)
|
249.63 Minutes
Standard Deviation 81.397
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
REM: Day 1
|
73.10 Minutes
Standard Deviation 20.976
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
REM: Day 8
|
77.52 Minutes
Standard Deviation 22.313
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
REM: Day 29
|
76.53 Minutes
Standard Deviation 25.039
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
REM: Without strip (Day 30 and 31)
|
52.84 Minutes
Standard Deviation 23.452
|
|
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
REM: With strip (Day 30 and 31)
|
55.04 Minutes
Standard Deviation 28.592
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Respiratory Effort Related Arousal (RERA) was flattening of an inspiratory portion of nasal pressure with increased respiratory effort leading to arousal. The total number of arousals per hour were calculated as RERA. RERA was measured all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Day 1
|
14.62 RERA per hour
Standard Deviation 9.006
|
|
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Day 8
|
16.80 RERA per hour
Standard Deviation 9.611
|
|
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Day 29
|
16.30 RERA per hour
Standard Deviation 10.602
|
|
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
20.65 RERA per hour
Standard Deviation 11.789
|
|
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
23.88 RERA per hour
Standard Deviation 13.757
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Arterial oxygen saturation (SAO2) is the fraction of \[oxygen\]-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. SAO2 in NREM and REM sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Lowest SAO2 values observed during the NREM and REM sleep were recorded for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
REM: Day 1
|
91.33 Percentage of SAO2
Standard Deviation 3.433
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
REM: Day 8
|
91.17 Percentage of SAO2
Standard Deviation 3.476
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
REM: Day 29
|
91.34 Percentage of SAO2
Standard Deviation 3.219
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
REM: Without strip (Day 29 and 30)
|
92.30 Percentage of SAO2
Standard Deviation 3.541
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
REM: With strip (Day 29 and 30)
|
92.42 Percentage of SAO2
Standard Deviation 3.494
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
NREM: Day 1
|
91.01 Percentage of SAO2
Standard Deviation 3.012
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
NREM: Day 8
|
90.24 Percentage of SAO2
Standard Deviation 3.684
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
NREM: Day 29
|
90.75 Percentage of SAO2
Standard Deviation 3.139
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
NREM: Without strip (Day 29 and 30)
|
91.88 Percentage of SAO2
Standard Deviation 3.386
|
|
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
NREM: With strip (Day 29 and 30)
|
91.96 Percentage of SAO2
Standard Deviation 3.200
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
SAO2 in sleep time was measured overnight by pulse oximetry with a finger probe using a computerized system. Mean of the observed SAO2 values during entire sleep time was reported for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 1
|
95.70 Percentage of SAO2
Standard Deviation 1.468
|
|
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 8
|
95.70 Percentage of SAO2
Standard Deviation 1.598
|
|
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Day 29
|
95.64 Percentage of SAO2
Standard Deviation 1.528
|
|
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
96.69 Percentage of SAO2
Standard Deviation 1.364
|
|
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
96.71 Percentage of SAO2
Standard Deviation 1.188
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Oxygen desaturation is the drop in blood's oxygen level per hours of sleep. Average drop in oxygen level during total sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Day 1
|
4.41 Percentage of oxygen desaturation
Standard Deviation 10.980
|
|
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Day 8
|
4.68 Percentage of oxygen desaturation
Standard Deviation 11.679
|
|
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Day 29
|
3.49 Percentage of oxygen desaturation
Standard Deviation 1.588
|
|
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
2.90 Percentage of oxygen desaturation
Standard Deviation 2.385
|
|
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
3.33 Percentage of oxygen desaturation
Standard Deviation 2.113
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Percent sleep time with SAO2 greater than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Day 1
|
98.59 Percentage of sleep time
Standard Deviation 3.397
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Day 8
|
97.38 Percentage of sleep time
Standard Deviation 7.383
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Day 29
|
98.21 Percentage of sleep time
Standard Deviation 4.021
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
98.41 Percentage of sleep time
Standard Deviation 4.016
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
99.18 Percentage of sleep time
Standard Deviation 1.381
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Percent sleep time with SAO2 less than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
0.49 Percentage of sleep time
Standard Deviation 2.533
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Day 1
|
0.66 Percentage of sleep time
Standard Deviation 2.863
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Day 8
|
1.29 Percentage of sleep time
Standard Deviation 6.713
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Day 29
|
0.56 Percentage of sleep time
Standard Deviation 2.742
|
|
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
0.12 Percentage of sleep time
Standard Deviation 0.475
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 30 and Day 31Population: Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.
Apnea/Hypopnea Index (AHI) was measured as the number of events (apnea and hypopnea) per hour of sleep. AHI was measured using overnight by PSG using a computerized system. PSG was performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Outcome measures
| Measure |
All Participants (Nasal Resistance Phase)
n=70 Participants
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule
|
|---|---|
|
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
With strip (Day 30 and 31)
|
7.11 AHI events per hour
Standard Deviation 12.948
|
|
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Day 1
|
4.08 AHI events per hour
Standard Deviation 5.499
|
|
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Day 8
|
4.26 AHI events per hour
Standard Deviation 5.273
|
|
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Day 29
|
5.07 AHI events per hour
Standard Deviation 7.371
|
|
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Without strip (Day 30 and 31)
|
6.57 AHI events per hour
Standard Deviation 10.489
|
Adverse Events
All Participants (Baseline Phase)
All Participants (Active Phase)
Participants With Strip (Nasal Resisatnce Phase)
Participants Without Strip (Nasal Resisatnce Phase)
Serious adverse events
| Measure |
All Participants (Baseline Phase)
n=91 participants at risk
All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1
|
All Participants (Active Phase)
n=70 participants at risk
All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment
|
Participants With Strip (Nasal Resisatnce Phase)
n=55 participants at risk
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who applied the strip.
|
Participants Without Strip (Nasal Resisatnce Phase)
n=55 participants at risk
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who did not applied the strip.
|
|---|---|---|---|---|
|
Infections and infestations
Bell's Palsy
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
Other adverse events
| Measure |
All Participants (Baseline Phase)
n=91 participants at risk
All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1
|
All Participants (Active Phase)
n=70 participants at risk
All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment
|
Participants With Strip (Nasal Resisatnce Phase)
n=55 participants at risk
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who applied the strip.
|
Participants Without Strip (Nasal Resisatnce Phase)
n=55 participants at risk
The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (Day 30 and Day 31) based on the randomization schedule. This arm represents the participants who did not applied the strip.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
2.9%
2/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
2.9%
2/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
7.1%
5/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
2.9%
2/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
5.7%
4/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
12.9%
9/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Psychiatric disorders
CLAUSTROPHOBIA
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.8%
1/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.8%
1/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
RHINALGIA
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.8%
1/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
General disorders
APPLICATION SITE REACTION
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Nervous system disorders
VIIth NERVE PARALYSIS
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
General disorders
APPLICATION SITE FISSURE
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
General disorders
Application site haematoma
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Investigations
BLOOD CHOLESTEROL Increased
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.8%
1/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/91 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
1.4%
1/70 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
0.00%
0/55 • Upto 31 days
Safety population included all participants to whom the study treatment was dispensed were considered evaluable for the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER