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A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)

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ClinicalTrials.gov Identifier: NCT03549117
Recruitment Status : Completed
First Posted : June 7, 2018
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Congestion, Nasal
Interventions Device: Breathe Right Tan (small/medium) nasal strips
Other: Placebo nasal strip
Enrollment 140
Recruitment Details All participants were recruited from two centers in USA
Pre-assignment Details 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.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 70 70
Completed 69 70
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
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.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
45.8  (14.12) 47.7  (13.19) 46.7  (13.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
43
  61.4%
49
  70.0%
92
  65.7%
Male
27
  38.6%
21
  30.0%
48
  34.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   7.1%
3
   4.3%
8
   5.7%
White
65
  92.9%
67
  95.7%
132
  94.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Sleep Problems Number Analyzed 69 participants 70 participants
-6.20
(-7.12 to -5.27)
-6.35
(-7.27 to -5.44)
Sleep Time Problems Number Analyzed 69 participants 70 participants
-7.30
(-8.39 to -6.21)
-6.60
(-7.68 to -5.52)
Symptoms on Walking in the Morning Number Analyzed 69 participants 70 participants
-7.18
(-8.20 to -6.17)
-7.00
(-8.01 to -5.99)
Practical Problems Number Analyzed 69 participants 70 participants
-2.86
(-3.45 to -2.27)
-3.01
(-3.59 to -2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8142
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-1.14 to 1.45
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3690
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-2.23 to 0.84
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7995
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-1.61 to 1.25
Estimation Comments Difference between treatments of LS mean change from baseline; between treatment 95% CI.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7285
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-0.69 to 0.98
Estimation Comments Difference between treatments of LS mean change from baseline.
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Sleep Problems Number Analyzed 68 participants 70 participants
-7.14
(-8.10 to -6.18)
-6.96
(-7.91 to -6.02)
Sleep Time Problems Number Analyzed 68 participants 70 participants
-8.31
(-9.41 to -7.21)
-7.44
(-8.53 to -6.36)
Symptoms on waking in the morning Number Analyzed 68 participants 70 participants
-7.65
(-8.74 to -6.56)
-7.57
(-8.64 to -6.50)
Practical Problems Number Analyzed 68 participants 70 participants
-3.48
(-4.06 to -2.90)
-3.42
(-3.98 to -2.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7961
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-1.52 to 1.17
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2710
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-2.41 to 0.68
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9236
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-1.60 to 1.45
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of NRQLQ between active and placebo strip group for practical problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8756
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.87 to 0.75
Estimation Comments Difference between treatments of LS mean change from baseline.
3.Primary Outcome
Title 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
Hide Description 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
Time Frame At Baseline and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N=140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Feel Tired and Unrefreshed Number Analyzed 69 participants 70 participants
-1.73
(-2.01 to -1.44)
-1.75
(-2.03 to -1.46)
Nasal congestion or stuffy nose Number Analyzed 69 participants 70 participants
-1.96
(-2.24 to -1.68)
-1.91
(-2.19 to -1.63)
Congestion in sinuses Number Analyzed 69 participants 70 participants
-1.72
(-2.00 to -1.45)
-1.73
(-2.01 to -1.46)
Takes time to clear nighttime drainage Number Analyzed 69 participants 70 participants
-1.76
(-2.04 to -1.47)
-1.62
(-1.90 to -1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9314
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.38 to 0.42
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8005
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.45 to 0.35
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9613
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.38 to 0.40
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4966
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.54 to 0.26
Estimation Comments Difference between treatments of LS mean change from baseline.
4.Primary Outcome
Title 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
Hide Description 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
Time Frame At Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Feel Tired and Unrefreshed Number Analyzed 68 participants 70 participants
-1.79
(-2.09 to -1.49)
-1.82
(-2.12 to -1.53)
Nasal congestion or stuffy nose Number Analyzed 68 participants 70 participants
-2.05
(-2.35 to -1.76)
-1.99
(-2.28 to -1.70)
Congestion in sinuses Number Analyzed 68 participants 70 participants
-1.81
(-2.12 to -1.51)
-1.85
(-2.15 to -1.56)
Takes time to clear nighttime Number Analyzed 68 participants 70 participants
-1.98
(-2.27 to -1.69)
-1.92
(-2.20 to -1.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8775
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.39 to 0.45
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7747
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.47 to 0.35
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8535
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.39 to 0.47
Estimation Comments Difference between treatments of LS mean change from baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7720
Comments Between treatment p-values.
Method ANCOVA
Comments From ANCOVA model, baseline used as a covariate and site as a factor in the model.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.47 to 0.35
Estimation Comments Difference between treatments of LS mean change from baseline.
5.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement:all of the items in sleep problems
31
  44.3%
32
  45.7%
Improvement:any of the items in sleep problems
64
  91.4%
68
  97.1%
Improvement:all of items in sleep time problems
28
  40.0%
24
  34.3%
Improvement:any of items in sleep time problems
66
  94.3%
67
  95.7%
Improvement:all of items in symptom on walking(AM)
41
  58.6%
40
  57.1%
Improvement:any of items in symptom on walking(AM)
67
  95.7%
66
  94.3%
Improvement:all of the items in practical problems
11
  15.7%
16
  22.9%
Improvement:any of the items in practical problems
60
  85.7%
64
  91.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9258
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2368
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4432
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9856
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7854
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4141
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3028
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3955
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
6.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and hadat least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement:all of the items in sleep problems
40
  57.1%
36
  51.4%
Improvement:any of the items in sleep problems
65
  92.9%
68
  97.1%
Improvement:all of items in sleep time problems
32
  45.7%
26
  37.1%
Improvement:any of items in sleep time problems
66
  94.3%
66
  94.3%
Improvement:all of items in symptom on walking(AM)
44
  62.9%
44
  62.9%
Improvement:any of items in symptom on walking(AM)
67
  95.7%
66
  94.3%
Improvement:all of the items in practical problems
17
  24.3%
19
  27.1%
Improvement:any of the items in practical problems
63
  90.0%
63
  90.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3826
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6251
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2381
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4245
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8213
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1823
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7744
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Active Nasal Strip Group, Placebo Nasal Strip Group
Comments Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5811
Comments [Not Specified]
Method Chi-squared
Comments P-value are based on chi-square test
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline, Day 1, 3, 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Day 1 (Q1) Number Analyzed 70 participants 70 participants
21.27
(15.98 to 26.55)
18.28
(13.03 to 23.53)
Day 3 (Q1) Number Analyzed 70 participants 70 participants
19.20
(14.19 to 24.21)
16.96
(11.95 to 21.97)
Day 7 (Q1) Number Analyzed 67 participants 68 participants
18.23
(13.21 to 23.24)
17.21
(12.27 to 22.15)
Day 14 (Q1) Number Analyzed 68 participants 69 participants
19.13
(14.39 to 23.87)
14.63
(9.93 to 19.34)
Day 1 (Q3) Number Analyzed 67 participants 67 participants
23.77
(18.16 to 29.39)
19.24
(13.66 to 24.81)
Day 3 (Q3) Number Analyzed 69 participants 68 participants
19.91
(14.89 to 24.94)
19.38
(14.35 to 24.40)
Day 7 (Q3) Number Analyzed 66 participants 67 participants
19.51
(14.32 to 24.71)
18.67
(13.56 to 23.79)
Day 14 (Q3) Number Analyzed 66 participants 69 participants
19.03
(14.04 to 24.01)
15.73
(10.86 to 20.60)
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline, Day 1, 3, 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Day 1 (Q1) Number Analyzed 70 participants 70 participants
20.94
(15.44 to 26.44)
23.30
(17.83 to 28.76)
Day 3 (Q1) Number Analyzed 70 participants 70 participants
19.12
(13.66 to 24.58)
17.57
(12.15 to 22.99)
Day 7 (Q1) Number Analyzed 67 participants 68 participants
18.88
(13.37 to 24.38)
18.34
(12.92 to 23.77)
Day 14 (Q1) Number Analyzed 69 participants 69 participants
20.11
(14.95 to 25.27)
17.22
(12.06 to 22.39)
Day 1 (Q3) Number Analyzed 68 participants 67 participants
22.60
(16.85 to 28.35)
23.18
(17.42 to 28.94)
Day 3 (Q3) Number Analyzed 69 participants 67 participants
19.51
(13.98 to 25.04)
16.90
(11.32 to 22.47)
Day 7 (Q3) Number Analyzed 66 participants 67 participants
17.81
(12.26 to 23.35)
18.85
(13.39 to 24.31)
Day 14 (Q3) Number Analyzed 67 participants 69 participants
18.65
(13.44 to 23.86)
15.47
(10.34 to 20.60)
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline, Day 1, 3, 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Day 1 Number Analyzed 70 participants 70 participants
-0.67
(-0.83 to -0.51)
-0.54
(-0.69 to -0.38)
Day 3 Number Analyzed 70 participants 69 participants
-0.48
(-0.63 to -0.33)
-0.43
(-0.57 to -0.28)
Day 7 Number Analyzed 66 participants 68 participants
-0.44
(-0.58 to -0.30)
-0.39
(-0.53 to -0.25)
Day 14 Number Analyzed 68 participants 68 participants
-0.50
(-0.65 to -0.36)
-0.33
(-0.47 to -0.19)
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline, Day 1, 3, 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Day 1 Number Analyzed 70 participants 70 participants
-0.65
(-0.80 to -0.49)
-0.65
(-0.81 to -0.50)
Day 3 Number Analyzed 70 participants 70 participants
-0.48
(-0.65 to -0.32)
-0.53
(-0.70 to -0.37)
Day 7 Number Analyzed 67 participants 68 participants
-0.53
(-0.69 to -0.37)
-0.56
(-0.72 to -0.40)
Day 14 Number Analyzed 69 participants 68 participants
-0.59
(-0.74 to -0.43)
-0.50
(-0.66 to -0.35)
11.Secondary Outcome
Title Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night
Hide Description

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.

Time Frame At Baseline, Day 1, 3, 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement from diary for easy to breath (Day 1)
63
  90.0%
56
  80.0%
Improvement from diary for stuffed nose (Day 1)
43
  61.4%
31
  44.3%
Improvement from diary for openness (Day 1)
61
  87.1%
53
  75.7%
Improvement from diary for easy to breath (Day 3)
61
  87.1%
60
  85.7%
Improvement from diary for stuffed nose (Day 3)
30
  42.9%
24
  34.3%
Improvement from diary for openness (Day 3)
58
  82.9%
57
  81.4%
Improvement from diary for easy to breath (Day 7)
54
  77.1%
61
  87.1%
Improvement from diary for stuffed nose (Day 7)
28
  40.0%
23
  32.9%
Improvement from diary for openness (Day 7)
54
  77.1%
56
  80.0%
Improvement from diary for easy to breath (Day 14)
53
  75.7%
53
  75.7%
Improvement from diary for stuffed nose (Day 14)
26
  37.1%
22
  31.4%
Improvement from diary for openness (Day 14)
55
  78.6%
55
  78.6%
Time Frame Approximately 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Nasal Strip Group Placebo Nasal Strip Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Active Nasal Strip Group Placebo Nasal Strip Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/70 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active Nasal Strip Group Placebo Nasal Strip Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/70 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Active Nasal Strip Group Placebo Nasal Strip Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/70 (8.57%)      7/70 (10.00%)    
Gastrointestinal disorders     
TONGUE ULCERATION   1/70 (1.43%)  1 0/70 (0.00%)  0
VOMITING   1/70 (1.43%)  1 0/70 (0.00%)  0
Infections and infestations     
SINUSITIS   2/70 (2.86%)  2 0/70 (0.00%)  0
PHARYNGITIS STREPTOCOCCAL   0/70 (0.00%)  0 1/70 (1.43%)  1
UPPER RESPIRATORY TRACT INFECTION   0/70 (0.00%)  0 1/70 (1.43%)  1
Injury, poisoning and procedural complications     
CONTUSION   0/70 (0.00%)  0 1/70 (1.43%)  1
Nervous system disorders     
HEADACHE   0/70 (0.00%)  0 1/70 (1.43%)  1
Respiratory, thoracic and mediastinal disorders     
NASAL DISCOMFORT   2/70 (2.86%)  2 0/70 (0.00%)  0
OROPHARYNGEAL PAIN   0/70 (0.00%)  0 2/70 (2.86%)  2
COUGH   1/70 (1.43%)  1 0/70 (0.00%)  0
UPPER-AIRWAY COUGH SYNDROME   0/70 (0.00%)  0 1/70 (1.43%)  1
Surgical and medical procedures     
SINUS OPERATION   0/70 (0.00%)  0 1/70 (1.43%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03549117     History of Changes
Other Study ID Numbers: 202245
B3570876 ( Other Identifier: GSK other Identifier )
First Submitted: May 25, 2018
First Posted: June 7, 2018
Results First Submitted: July 30, 2018
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018