Trial Outcomes & Findings for A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips) (NCT NCT03549130)
NCT ID: NCT03549130
Last Updated: 2018-09-25
Results Overview
Participants scored all the domains of NRQLQ using same 7 points scales where 0=Not troubled and 6=extremely troubled. Domains: 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
130 participants
At baseline and Day 7
2018-09-25
Participant Flow
All participants were recruited at two centers in USA.
A total of 235 participates were screened, out of which 130 participants were enrolled and randomized in the study. 105 participants were not randomized as 104 of which did not meet study criteria, 1 had adverse event.
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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
|
Overall Study
COMPLETED
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)
Baseline characteristics by cohort
| Measure |
Active Nasal Strip Group
n=64 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=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
47.1 Years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 13.74 • n=7 Participants
|
47.8 Years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 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
|
1 Participants
n=7 Participants
|
1 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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 ITT (N= 128) 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 scales where 0=Not troubled and 6=extremely troubled. Domains: 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 |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Sleep Problems
|
-4.17 Score on Scale
Interval -5.09 to -3.25
|
-4.94 Score on Scale
Interval -5.85 to -4.02
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Sleep Time Problems
|
-4.51 Score on Scale
Interval -5.67 to -3.34
|
-6.30 Score on Scale
Interval -7.46 to -5.14
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Symptoms on waking in the morning
|
-4.87 Score on Scale
Interval -5.93 to -3.8
|
-6.49 Score on Scale
Interval -7.55 to -5.44
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7
Practical problems
|
-2.28 Score on Scale
Interval -3.0 to -1.56
|
-2.98 Score on Scale
Interval -3.7 to -2.27
|
PRIMARY outcome
Timeframe: At Baseline and Day 14Population: The ITT (N= 128) 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 scales where 0=Not troubled and 6=extremely troubled. Domains: 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 |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Sleep Problems
|
-5.87 Score On scale
Interval -6.85 to -4.89
|
-6.34 Score On scale
Interval -7.31 to -5.36
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Sleep Time Problems
|
-6.32 Score On scale
Interval -7.5 to -5.15
|
-7.30 Score On scale
Interval -8.47 to -6.12
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Symptoms on Walking in the Morning
|
-6.54 Score On scale
Interval -7.56 to -5.52
|
-7.25 Score On scale
Interval -8.28 to -6.23
|
|
Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14
Practical Problems
|
-2.66 Score On scale
Interval -3.36 to -1.95
|
-3.47 Score On scale
Interval -4.17 to -2.77
|
PRIMARY outcome
Timeframe: At Baseline and Day 7Population: The ITT (N= 128) 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 night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms
Outcome measures
| Measure |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Feel Tired and Unrefreshed
|
-1.15 Score on Scale
Interval -1.45 to -0.84
|
-1.40 Score on Scale
Interval -1.7 to -1.1
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Nasal congestion or stuffy nose
|
-1.34 Score on Scale
Interval -1.63 to -1.05
|
-1.71 Score on Scale
Interval -2.0 to -1.43
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Congestion in sinuses
|
-1.04 Score on Scale
Interval -1.36 to -0.73
|
-1.59 Score on Scale
Interval -1.9 to -1.28
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7
Takes time to clear nighttime drainage
|
-1.33 Score on Scale
Interval -1.66 to -1.0
|
-1.80 Score on Scale
Interval -2.13 to -1.47
|
PRIMARY outcome
Timeframe: At Baseline and Day 14Population: The ITT (N= 128) 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 night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms
Outcome measures
| Measure |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Feel Tired and Unrefreshed
|
-1.46 Score on Scale
Interval -1.72 to -1.2
|
-1.65 Score on Scale
Interval -1.92 to -1.39
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Nasal congestion or stuffy nose
|
-1.82 Score on Scale
Interval -2.11 to -1.52
|
-1.96 Score on Scale
Interval -2.26 to -1.67
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Congestion in sinuses
|
-1.70 Score on Scale
Interval -1.99 to -1.41
|
-1.71 Score on Scale
Interval -2.0 to -1.42
|
|
Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Takes time to clear nighttime
|
-1.56 Score on Scale
Interval -1.89 to -1.24
|
-1.93 Score on Scale
Interval -2.26 to -1.6
|
PRIMARY outcome
Timeframe: At Day 7Population: The ITT (N= 128) 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 |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:all of the items in sleep problems
|
21 Participants
|
20 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:any of the items in sleep problems
|
61 Participants
|
59 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:all of items in sleep time problems
|
17 Participants
|
21 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:any of items in sleep time problems
|
61 Participants
|
58 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:all of items in symptom on walking(AM)
|
28 Participants
|
37 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:any of items in symptom on walking(AM)
|
58 Participants
|
60 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:all of the items in practical problems
|
12 Participants
|
9 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7
Improvement:any of the items in practical problems
|
48 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: The ITT (N= 128) 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 |
Placebo Nasal Strip Group
n=64 Participants
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
|
Active Nasal Strip Group
n=64 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.
|
|---|---|---|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:all of the items in sleep problems
|
34 Participants
|
31 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:any of the items in sleep problems
|
60 Participants
|
59 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:all of items in sleep time problems
|
26 Participants
|
24 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:any of items in sleep time problems
|
62 Participants
|
60 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:all of items in symptom on walking(AM)
|
39 Participants
|
35 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:any of items in symptom on walking(AM)
|
63 Participants
|
62 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:all of the items in practical problems
|
13 Participants
|
14 Participants
|
|
Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14
Improvement:any of the items in practical problems
|
51 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=64 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=64 participants at risk
Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
|
|---|---|---|
|
General disorders
APPLICATION SITE PRURITUS
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
|
General disorders
APPLICATION SITE DISCOLOURATION
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • Approximately 21 days
|
|
General disorders
APPLICATION SITE ERYTHEMA
|
0.00%
0/64 • Approximately 21 days
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
|
General disorders
APPLICATION SITE IRRITATION
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • Approximately 21 days
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
0.00%
0/64 • Approximately 21 days
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • Approximately 21 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.6%
1/64 • Number of events 1 • Approximately 21 days
|
0.00%
0/64 • 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