18 and older, any sex, with Congestion, Nasal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 7Primary· At baseline and Day 7
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 a
Sleep Problems
Group
Value
95% CI
Active Nasal Strip Group
-4.94
-5.85 – -4.02
Placebo Nasal Strip Group
-4.17
-5.09 – -3.25
Sleep Time Problems
Group
Value
95% CI
Active Nasal Strip Group
-6.30
-7.46 – -5.14
Placebo Nasal Strip Group
-4.51
-5.67 – -3.34
Symptoms on waking in the morning
Group
Value
95% CI
Active Nasal Strip Group
-6.49
-7.55 – -5.44
Placebo Nasal Strip Group
-4.87
-5.93 – -3.80
Practical problems
Group
Value
95% CI
Active Nasal Strip Group
-2.98
-3.70 – -2.27
Placebo Nasal Strip Group
-2.28
-3.00 – -1.56
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 14Primary· At Baseline and Day 14
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 a
Sleep Problems
Group
Value
95% CI
Active Nasal Strip Group
-6.34
-7.31 – -5.36
Placebo Nasal Strip Group
-5.87
-6.85 – -4.89
Sleep Time Problems
Group
Value
95% CI
Active Nasal Strip Group
-7.30
-8.47 – -6.12
Placebo Nasal Strip Group
-6.32
-7.50 – -5.15
Symptoms on Walking in the Morning
Group
Value
95% CI
Active Nasal Strip Group
-7.25
-8.28 – -6.23
Placebo Nasal Strip Group
-6.54
-7.56 – -5.52
Practical Problems
Group
Value
95% CI
Active Nasal Strip Group
-3.47
-4.17 – -2.77
Placebo Nasal Strip Group
-2.66
-3.36 – -1.95
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 7Primary· At Baseline and Day 7
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
Feel Tired and Unrefreshed
Group
Value
95% CI
Active Nasal Strip Group
-1.40
-1.70 – -1.10
Placebo Nasal Strip Group
-1.15
-1.45 – -0.84
Nasal congestion or stuffy nose
Group
Value
95% CI
Active Nasal Strip Group
-1.71
-2.00 – -1.43
Placebo Nasal Strip Group
-1.34
-1.63 – -1.05
Congestion in sinuses
Group
Value
95% CI
Active Nasal Strip Group
-1.59
-1.90 – -1.28
Placebo Nasal Strip Group
-1.04
-1.36 – -0.73
Takes time to clear nighttime drainage
Group
Value
95% CI
Active Nasal Strip Group
-1.80
-2.13 – -1.47
Placebo Nasal Strip Group
-1.33
-1.66 – -1.00
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 14Primary· At Baseline and Day 14
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
Feel Tired and Unrefreshed
Group
Value
95% CI
Active Nasal Strip Group
-1.65
-1.92 – -1.39
Placebo Nasal Strip Group
-1.46
-1.72 – -1.20
Nasal congestion or stuffy nose
Group
Value
95% CI
Active Nasal Strip Group
-1.96
-2.26 – -1.67
Placebo Nasal Strip Group
-1.82
-2.11 – -1.52
Congestion in sinuses
Group
Value
95% CI
Active Nasal Strip Group
-1.71
-2.00 – -1.42
Placebo Nasal Strip Group
-1.70
-1.99 – -1.41
Takes time to clear nighttime
Group
Value
95% CI
Active Nasal Strip Group
-1.93
-2.26 – -1.60
Placebo Nasal Strip Group
-1.56
-1.89 – -1.24
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 7Primary· At Day 7
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);Sympt
Improvement:all of the items in sleep problems
Group
Value
95% CI
Active Nasal Strip Group
20
Placebo Nasal Strip Group
21
Improvement:any of the items in sleep problems
Group
Value
95% CI
Active Nasal Strip Group
59
Placebo Nasal Strip Group
61
Improvement:all of items in sleep time problems
Group
Value
95% CI
Active Nasal Strip Group
21
Placebo Nasal Strip Group
17
Improvement:any of items in sleep time problems
Group
Value
95% CI
Active Nasal Strip Group
58
Placebo Nasal Strip Group
61
Improvement:all of items in symptom on walking(AM)
Group
Value
95% CI
Active Nasal Strip Group
37
Placebo Nasal Strip Group
28
Improvement:any of items in symptom on walking(AM)
Group
Value
95% CI
Active Nasal Strip Group
60
Placebo Nasal Strip Group
58
Improvement:all of the items in practical problems
Group
Value
95% CI
Active Nasal Strip Group
9
Placebo Nasal Strip Group
12
Improvement:any of the items in practical problems
Group
Value
95% CI
Active Nasal Strip Group
53
Placebo Nasal Strip Group
48
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 14Primary· At Day 14
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);Sympt
Improvement:all of the items in sleep problems
Group
Value
95% CI
Active Nasal Strip Group
31
Placebo Nasal Strip Group
34
Improvement:any of the items in sleep problems
Group
Value
95% CI
Active Nasal Strip Group
59
Placebo Nasal Strip Group
60
Improvement:all of items in sleep time problems
Group
Value
95% CI
Active Nasal Strip Group
24
Placebo Nasal Strip Group
26
Improvement:any of items in sleep time problems
Group
Value
95% CI
Active Nasal Strip Group
60
Placebo Nasal Strip Group
62
Improvement:all of items in symptom on walking(AM)
Group
Value
95% CI
Active Nasal Strip Group
35
Placebo Nasal Strip Group
39
Improvement:any of items in symptom on walking(AM)
Group
Value
95% CI
Active Nasal Strip Group
62
Placebo Nasal Strip Group
63
Improvement:all of the items in practical problems
Group
Value
95% CI
Active Nasal Strip Group
14
Placebo Nasal Strip Group
13
Improvement:any of the items in practical problems
Group
Value
95% CI
Active Nasal Strip Group
55
Placebo Nasal Strip Group
51
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 21 days.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized, double-blind, parallel group, placebo-controlled study assessed subjective measures of nasal airway breathing immediately after application in the morning upon awakening after use of breathe right nasal strips (BRNS). Participants who met the entrance criteria, were currently suffering from nasal congestion, reported trouble with their sleep and had baseline nasal openness scores at bedtime during the qualification phase of ≤ 70 on a 100-point Visual Analogue Scale (VAS) on at least four of seven qualification nights were randomized to one of two treatments for use at home. Participants returned to the study site after 7 and 14 days of nightly nasal strip use, respectively. At the two return visits, a validated subjective questionnaire, the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), measured response.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Other trials of Breathe Right Tan (small/medium) nasal strips
Trials testing the same drug.
NCT03549117 — A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)
· Phase 2
· completed
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 25 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03549130.