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A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)

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ClinicalTrials.gov Identifier: NCT03549130
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 130
Recruitment Details All participants were recruited at two centers in USA.
Pre-assignment Details 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.
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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Period Title: Overall Study
Started 64 66
Completed 64 64
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             0             1
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 (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 64 64 128
Hide Baseline Analysis Population Description
The ITT (N= 128) population included all 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 64 participants 64 participants 128 participants
47.1  (11.27) 48.4  (13.74) 47.8  (12.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
Female
48
  75.0%
44
  68.8%
92
  71.9%
Male
16
  25.0%
20
  31.3%
36
  28.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 128 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.6%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  12.5%
9
  14.1%
17
  13.3%
White
55
  85.9%
52
  81.3%
107
  83.6%
More than one race
1
   1.6%
2
   3.1%
3
   2.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame At baseline and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Overall Number of Participants Analyzed 64 64
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Sleep Problems
-4.94
(-5.85 to -4.02)
-4.17
(-5.09 to -3.25)
Sleep Time Problems
-6.30
(-7.46 to -5.14)
-4.51
(-5.67 to -3.34)
Symptoms on waking in the morning
-6.49
(-7.55 to -5.44)
-4.87
(-5.93 to -3.80)
Practical problems
-2.98
(-3.70 to -2.27)
-2.28
(-3.00 to -1.56)
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 0.2446
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter Least Square (LS) mean difference
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-2.06 to 0.53
Estimation Comments Difference between treatments of adjusted 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 0.0333
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-3.45 to -0.14
Estimation Comments Difference between treatments of adjusted 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 0.0345
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.63
Confidence Interval (2-Sided) 95%
-3.13 to -0.12
Estimation Comments Difference between treatments of adjusted 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 0.1711
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.72 to 0.31
Estimation Comments Difference between treatments of adjusted mean change from baseline.
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT (N= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions
Overall Number of Participants Analyzed 64 64
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score On scale
Sleep Problems
-6.34
(-7.31 to -5.36)
-5.87
(-6.85 to -4.89)
Sleep Time Problems
-7.30
(-8.47 to -6.12)
-6.32
(-7.50 to -5.15)
Symptoms on Walking in the Morning
-7.25
(-8.28 to -6.23)
-6.54
(-7.56 to -5.52)
Practical Problems
-3.47
(-4.17 to -2.77)
-2.66
(-3.36 to -1.95)
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 0.5063
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-1.85 to 0.92
Estimation Comments Difference between treatments of adjusted 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 0.2496
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-2.64 to 0.69
Estimation Comments Difference between treatments of adjusted 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 0.3325
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-2.16 to 0.74
Estimation Comments Difference between treatments of adjusted 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 0.1088
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.81 to 0.18
Estimation Comments Difference between treatments of adjusted mean change from baseline.
3.Primary Outcome
Title 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
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 night time 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= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Overall Number of Participants Analyzed 64 64
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Feel Tired and Unrefreshed
-1.40
(-1.70 to -1.10)
-1.15
(-1.45 to -0.84)
Nasal congestion or stuffy nose
-1.71
(-2.00 to -1.43)
-1.34
(-1.63 to -1.05)
Congestion in sinuses
-1.59
(-1.90 to -1.28)
-1.04
(-1.36 to -0.73)
Takes time to clear nighttime drainage
-1.80
(-2.13 to -1.47)
-1.33
(-1.66 to -1.00)
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 0.2513
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.68 to 0.18
Estimation Comments Difference between treatments of adjusted 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 0.0743
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.78 to 0.04
Estimation Comments Difference between treatments of adjusted 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 0.0158
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.99 to -0.10
Estimation Comments Difference between treatments of adjusted 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 0.0489
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.94 to 0.00
Estimation Comments Difference between treatments of adjusted mean change from baseline.
4.Primary Outcome
Title 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
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 night time 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= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Overall Number of Participants Analyzed 64 64
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on Scale
Feel Tired and Unrefreshed
-1.65
(-1.92 to -1.39)
-1.46
(-1.72 to -1.20)
Nasal congestion or stuffy nose
-1.96
(-2.26 to -1.67)
-1.82
(-2.11 to -1.52)
Congestion in sinuses
-1.71
(-2.00 to -1.42)
-1.70
(-1.99 to -1.41)
Takes time to clear nighttime
-1.93
(-2.26 to -1.60)
-1.56
(-1.89 to -1.24)
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 0.3034
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.57 to 0.18
Estimation Comments Difference between treatments of adjusted 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 0.4891
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.57 to 0.27
Estimation Comments Difference between treatments of adjusted 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 0.9498
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.43 to 0.40
Estimation Comments Difference between treatments of adjusted 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 0.1235
Comments Between treatment p-values.
Method ANCOVA
Comments Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.83 to 0.10
Estimation Comments Difference between treatments of adjusted mean change from baseline.
5.Primary Outcome
Title 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
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= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Overall Number of Participants Analyzed 64 64
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement:all of the items in sleep problems
20
  31.3%
21
  32.8%
Improvement:any of the items in sleep problems
59
  92.2%
61
  95.3%
Improvement:all of items in sleep time problems
21
  32.8%
17
  26.6%
Improvement:any of items in sleep time problems
58
  90.6%
61
  95.3%
Improvement:all of items in symptom on walking(AM)
37
  57.8%
28
  43.8%
Improvement:any of items in symptom on walking(AM)
60
  93.8%
58
  90.6%
Improvement:all of the items in practical problems
9
  14.1%
12
  18.8%
Improvement:any of the items in practical problems
53
  82.8%
48
  75.0%
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 0.8498
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.4652
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.4390
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.2997
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.1116
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.5101
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.4740
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.2787
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
6.Primary Outcome
Title 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
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= 128) 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 (small/medium size) outside of the nose, from alar crease to alar crease, as per dispensing instructions.
Overall Number of Participants Analyzed 64 64
Measure Type: Count of Participants
Unit of Measure: Participants
Improvement:all of the items in sleep problems
31
  48.4%
34
  53.1%
Improvement:any of the items in sleep problems
59
  92.2%
60
  93.8%
Improvement:all of items in sleep time problems
24
  37.5%
26
  40.6%
Improvement:any of items in sleep time problems
60
  93.8%
62
  96.9%
Improvement:all of items in symptom on walking(AM)
35
  54.7%
39
  60.9%
Improvement:any of items in symptom on walking(AM)
62
  96.9%
63
  98.4%
Improvement:all of the items in practical problems
14
  21.9%
13
  20.3%
Improvement:any of the items in practical problems
55
  85.9%
51
  79.7%
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 0.5958
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.7296
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.7171
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.4030
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.4741
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.5591
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.8285
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 0.3487
Comments P-value are based on chi-square test
Method Chi-squared
Comments [Not Specified]
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 (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   0/64 (0.00%)      0/64 (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   0/64 (0.00%)      0/64 (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   6/64 (9.38%)      2/64 (3.13%)    
General disorders     
APPLICATION SITE PRURITUS   1/64 (1.56%)  1 1/64 (1.56%)  1
APPLICATION SITE DISCOLOURATION   1/64 (1.56%)  1 0/64 (0.00%)  0
APPLICATION SITE ERYTHEMA   0/64 (0.00%)  0 1/64 (1.56%)  1
APPLICATION SITE IRRITATION   1/64 (1.56%)  1 0/64 (0.00%)  0
INFLUENZA LIKE ILLNESS   1/64 (1.56%)  1 0/64 (0.00%)  0
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION   1/64 (1.56%)  1 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
NASAL CONGESTION   1/64 (1.56%)  1 0/64 (0.00%)  0
NASAL DISCOMFORT   0/64 (0.00%)  0 1/64 (1.56%)  1
OROPHARYNGEAL PAIN   1/64 (1.56%)  1 0/64 (0.00%)  0
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03549130     History of Changes
Other Study ID Numbers: 202246
B3570877 ( 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