Trial Outcomes & Findings for A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan) (NCT NCT03549117)
NCT ID: NCT03549117
Last Updated: 2018-09-25
Results Overview
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless \[tossing and turning\] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max \[0-24\]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip \[drainage down back of nose/throat\], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
COMPLETED
PHASE2
140 participants
At Baseline and Day 7
2018-09-25
Participant Flow
All participants were recruited from two centers in USA
A total of 200 participants were screened. Out of which 140 participant were randomized in the study. 60 participants were not randomized as 52 of which did not meet study criteria, 2 had adverse event, 3 were lost to follow up, 2 withdrew consent and 1 because of other (unspecified) reason.
Participant milestones
| Measure |
Active Nasal Strip Group
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active Nasal Strip Group
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)
Baseline characteristics by cohort
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
45.8 years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 13.19 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Day 7Population: The Intent to treat (ITT) (n=140) population included all the participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless \[tossing and turning\] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max \[0-24\]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip \[drainage down back of nose/throat\], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Sleep Problems
|
-6.20 Score on Scale
Interval -7.12 to -5.27
|
-6.35 Score on Scale
Interval -7.27 to -5.44
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Sleep Time Problems
|
-7.30 Score on Scale
Interval -8.39 to -6.21
|
-6.60 Score on Scale
Interval -7.68 to -5.52
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Symptoms on Walking in the Morning
|
-7.18 Score on Scale
Interval -8.2 to -6.17
|
-7.00 Score on Scale
Interval -8.01 to -5.99
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Practical Problems
|
-2.86 Score on Scale
Interval -3.45 to -2.27
|
-3.01 Score on Scale
Interval -3.59 to -2.42
|
PRIMARY outcome
Timeframe: At Baseline and Day 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless \[tossing and turning\] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max \[0-24\]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip \[drainage down back of nose/throat\], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Sleep Problems
|
-7.14 Score on Scale
Interval -8.1 to -6.18
|
-6.96 Score on Scale
Interval -7.91 to -6.02
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Sleep Time Problems
|
-8.31 Score on Scale
Interval -9.41 to -7.21
|
-7.44 Score on Scale
Interval -8.53 to -6.36
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Symptoms on waking in the morning
|
-7.65 Score on Scale
Interval -8.74 to -6.56
|
-7.57 Score on Scale
Interval -8.64 to -6.5
|
|
Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Practical Problems
|
-3.48 Score on Scale
Interval -4.06 to -2.9
|
-3.42 Score on Scale
Interval -3.98 to -2.85
|
PRIMARY outcome
Timeframe: At Baseline and Day 7Population: The ITT (N=140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Feel Tired and Unrefreshed
|
-1.73 Score on Scale
Interval -2.01 to -1.44
|
-1.75 Score on Scale
Interval -2.03 to -1.46
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Nasal congestion or stuffy nose
|
-1.96 Score on Scale
Interval -2.24 to -1.68
|
-1.91 Score on Scale
Interval -2.19 to -1.63
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Congestion in sinuses
|
-1.72 Score on Scale
Interval -2.0 to -1.45
|
-1.73 Score on Scale
Interval -2.01 to -1.46
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Takes time to clear nighttime drainage
|
-1.76 Score on Scale
Interval -2.04 to -1.47
|
-1.62 Score on Scale
Interval -1.9 to -1.34
|
PRIMARY outcome
Timeframe: At Baseline and Day 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3= moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Takes time to clear nighttime
|
-1.98 Score on Scale
Interval -2.27 to -1.69
|
-1.92 Score on Scale
Interval -2.2 to -1.63
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Feel Tired and Unrefreshed
|
-1.79 Score on Scale
Interval -2.09 to -1.49
|
-1.82 Score on Scale
Interval -2.12 to -1.53
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Nasal congestion or stuffy nose
|
-2.05 Score on Scale
Interval -2.35 to -1.76
|
-1.99 Score on Scale
Interval -2.28 to -1.7
|
|
Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Congestion in sinuses
|
-1.81 Score on Scale
Interval -2.12 to -1.51
|
-1.85 Score on Scale
Interval -2.15 to -1.56
|
PRIMARY outcome
Timeframe: At Day 7Population: The ITT (N= 140) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.
Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless \[tossing and turning\],having to get up because stuffy nose or blow nose using score,scores range:Min-Max\[0-24\]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip\[drainage down back of nose/throat\],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers\[such as dust,cigarette smoke,strong smells,perfumes\],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:all of the items in sleep problems
|
31 Participants
|
32 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:any of the items in sleep problems
|
64 Participants
|
68 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:all of items in sleep time problems
|
28 Participants
|
24 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:any of items in sleep time problems
|
66 Participants
|
67 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:all of items in symptom on walking(AM)
|
41 Participants
|
40 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:any of items in symptom on walking(AM)
|
67 Participants
|
66 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:all of the items in practical problems
|
11 Participants
|
16 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Improvement:any of the items in practical problems
|
60 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The ITT (N= 140) population included all participants who were randomized into the study and hadat least one post-baseline efficacy assessment.
Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless \[tossing and turning\],having to get up because stuffy nose or blow nose using score,scores range:Min-Max\[0-24\]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip\[drainage down back of nose/throat\],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers\[such as dust,cigarette smoke,strong smells,perfumes\],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:all of the items in sleep problems
|
40 Participants
|
36 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:any of the items in sleep problems
|
65 Participants
|
68 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:all of items in sleep time problems
|
32 Participants
|
26 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:any of items in sleep time problems
|
66 Participants
|
66 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:all of items in symptom on walking(AM)
|
44 Participants
|
44 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:any of items in symptom on walking(AM)
|
67 Participants
|
66 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:all of the items in practical problems
|
17 Participants
|
19 Participants
|
|
Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14
Improvement:any of the items in practical problems
|
63 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: At Baseline, Day 1, 3, 7 and 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants were asked how easy it was to breathe through their nose \[Q1\], how open your nose feels at this time \[Q3\] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 1 (Q1)
|
21.27 Score on Scale
Interval 15.98 to 26.55
|
18.28 Score on Scale
Interval 13.03 to 23.53
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 3 (Q1)
|
19.20 Score on Scale
Interval 14.19 to 24.21
|
16.96 Score on Scale
Interval 11.95 to 21.97
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 7 (Q1)
|
18.23 Score on Scale
Interval 13.21 to 23.24
|
17.21 Score on Scale
Interval 12.27 to 22.15
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 14 (Q1)
|
19.13 Score on Scale
Interval 14.39 to 23.87
|
14.63 Score on Scale
Interval 9.93 to 19.34
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 1 (Q3)
|
23.77 Score on Scale
Interval 18.16 to 29.39
|
19.24 Score on Scale
Interval 13.66 to 24.81
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 3 (Q3)
|
19.91 Score on Scale
Interval 14.89 to 24.94
|
19.38 Score on Scale
Interval 14.35 to 24.4
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 7 (Q3)
|
19.51 Score on Scale
Interval 14.32 to 24.71
|
18.67 Score on Scale
Interval 13.56 to 23.79
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night
Day 14 (Q3)
|
19.03 Score on Scale
Interval 14.04 to 24.01
|
15.73 Score on Scale
Interval 10.86 to 20.6
|
SECONDARY outcome
Timeframe: At Baseline, Day 1, 3, 7 and 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants were asked how easy it was to breathe through their nose \[Q1\], how open your nose feels at this time \[Q3\] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 1 (Q1)
|
20.94 Score on Scale
Interval 15.44 to 26.44
|
23.30 Score on Scale
Interval 17.83 to 28.76
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 3 (Q1)
|
19.12 Score on Scale
Interval 13.66 to 24.58
|
17.57 Score on Scale
Interval 12.15 to 22.99
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 7 (Q1)
|
18.88 Score on Scale
Interval 13.37 to 24.38
|
18.34 Score on Scale
Interval 12.92 to 23.77
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 14 (Q1)
|
20.11 Score on Scale
Interval 14.95 to 25.27
|
17.22 Score on Scale
Interval 12.06 to 22.39
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 1 (Q3)
|
22.60 Score on Scale
Interval 16.85 to 28.35
|
23.18 Score on Scale
Interval 17.42 to 28.94
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 3 (Q3)
|
19.51 Score on Scale
Interval 13.98 to 25.04
|
16.90 Score on Scale
Interval 11.32 to 22.47
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 7 (Q3)
|
17.81 Score on Scale
Interval 12.26 to 23.35
|
18.85 Score on Scale
Interval 13.39 to 24.31
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning
Day 14 (Q3)
|
18.65 Score on Scale
Interval 13.44 to 23.86
|
15.47 Score on Scale
Interval 10.34 to 20.6
|
SECONDARY outcome
Timeframe: At Baseline, Day 1, 3, 7 and 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night
Day 1
|
-0.67 Score on Scale
Interval -0.83 to -0.51
|
-0.54 Score on Scale
Interval -0.69 to -0.38
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night
Day 3
|
-0.48 Score on Scale
Interval -0.63 to -0.33
|
-0.43 Score on Scale
Interval -0.57 to -0.28
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night
Day 7
|
-0.44 Score on Scale
Interval -0.58 to -0.3
|
-0.39 Score on Scale
Interval -0.53 to -0.25
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night
Day 14
|
-0.50 Score on Scale
Interval -0.65 to -0.36
|
-0.33 Score on Scale
Interval -0.47 to -0.19
|
SECONDARY outcome
Timeframe: At Baseline, Day 1, 3, 7 and 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning
Day 1
|
-0.65 Score on Scale
Interval -0.8 to -0.49
|
-0.65 Score on Scale
Interval -0.81 to -0.5
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning
Day 3
|
-0.48 Score on Scale
Interval -0.65 to -0.32
|
-0.53 Score on Scale
Interval -0.7 to -0.37
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning
Day 7
|
-0.53 Score on Scale
Interval -0.69 to -0.37
|
-0.56 Score on Scale
Interval -0.72 to -0.4
|
|
Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning
Day 14
|
-0.59 Score on Scale
Interval -0.74 to -0.43
|
-0.50 Score on Scale
Interval -0.66 to -0.35
|
SECONDARY outcome
Timeframe: At Baseline, Day 1, 3, 7 and 14Population: The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Participants were asked following daily diary VAS scale questions Q1 How easy it was to breathe through your nose, Q2 how stuffed their nose felt and Q3 How open their nose feels at this time. Q1 was scored using 100 mm VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. Q3 was scored using 100 mm VAS scale where 0=extremely blocked, 100=extremely open. Q2 was scored using a scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms.
Outcome measures
| Measure |
Active Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for easy to breath (Day 1)
|
63 Participants
|
56 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for stuffed nose (Day 1)
|
43 Participants
|
31 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for openness (Day 1)
|
61 Participants
|
53 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for easy to breath (Day 3)
|
61 Participants
|
60 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for stuffed nose (Day 3)
|
30 Participants
|
24 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for openness (Day 3)
|
58 Participants
|
57 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for easy to breath (Day 7)
|
54 Participants
|
61 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for stuffed nose (Day 7)
|
28 Participants
|
23 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for openness (Day 7)
|
54 Participants
|
56 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for easy to breath (Day 14)
|
53 Participants
|
53 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for stuffed nose (Day 14)
|
26 Participants
|
22 Participants
|
|
Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Improvement from diary for openness (Day 14)
|
55 Participants
|
55 Participants
|
Adverse Events
Active Nasal Strip Group
Placebo Nasal Strip Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Nasal Strip Group
n=70 participants at risk
Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Placebo Nasal Strip Group
n=70 participants at risk
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH nasal strips placebo nasal strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
2.9%
2/70 • Number of events 2 • Approximately 21 days
|
0.00%
0/70 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/70 • Approximately 21 days
|
2.9%
2/70 • Number of events 2 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
0.00%
0/70 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
|
Infections and infestations
SINUSITIS
|
2.9%
2/70 • Number of events 2 • Approximately 21 days
|
0.00%
0/70 • Approximately 21 days
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
|
Gastrointestinal disorders
TONGUE ULCERATION
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
0.00%
0/70 • Approximately 21 days
|
|
Gastrointestinal disorders
VOMITING
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
0.00%
0/70 • Approximately 21 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
|
Surgical and medical procedures
SINUS OPERATION
|
0.00%
0/70 • Approximately 21 days
|
1.4%
1/70 • Number of events 1 • Approximately 21 days
|
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