18 and older, any sex, with Sleep Disorders or 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 Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7Primary· At Baseline and Day 7
The PIRS questionnaire had 3 sections (Section A \[Q1 to Q12\], Section B \[Q13 to 16\] and Section C \[Q17 to Q20\]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= b
Q1
Group
Value
95% CI
Marketed Nasal Strip
-0.911
-1.21 – -0.61
Placebo Nasal Strip
-0.694
-0.99 – -0.40
Prototype Nasal Strip
-1.032
-1.34 – -0.72
Q3
Group
Value
95% CI
Marketed Nasal Strip
-1.004
-1.37 – -0.63
Placebo Nasal Strip
-0.708
-1.07 – -0.34
Prototype Nasal Strip
-0.947
-1.33 – -0.56
Q17
Group
Value
95% CI
Marketed Nasal Strip
-0.721
-1.01 – -0.43
Placebo Nasal Strip
-0.349
-0.63 – -0.07
Prototype Nasal Strip
-0.539
-0.84 – -0.24
Q18
Group
Value
95% CI
Marketed Nasal Strip
-0.643
-0.91 – -0.38
Placebo Nasal Strip
-0.234
-0.50 – 0.03
Prototype Nasal Strip
-0.697
-0.98 – -0.42
Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14Primary· At Baseline and Day 14
Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn't sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hou
Q1 (One or more awakenings after getting to sleep)
Group
Value
95% CI
Marketed Nasal Strip
-1.047
-1.36 – -0.74
Placebo Nasal Strip
-0.844
-1.14 – -0.54
Prototype Nasal Strip
-1.157
-1.48 – -0.84
Q3 (Sleep that does not fully refresh you)
Group
Value
95% CI
Marketed Nasal Strip
-1.306
-1.69 – -0.92
Placebo Nasal Strip
-0.917
-1.30 – -0.54
Prototype Nasal Strip
-1.104
-1.50 – -0.70
Q17 (Your sleep quality compared to most people)
Group
Value
95% CI
Marketed Nasal Strip
-0.714
-1.04 – -0.39
Placebo Nasal Strip
-0.359
-0.68 – -0.04
Prototype Nasal Strip
-0.837
-1.17 – -0.50
Q18 (Your satisfaction with your sleep)
Group
Value
95% CI
Marketed Nasal Strip
-0.873
-1.18 – -0.57
Placebo Nasal Strip
-0.464
-0.76 – -0.16
Prototype Nasal Strip
-0.951
-1.27 – -0.63
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7Primary· At Baseline and Day 7
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 unrefres
Sleep Problems
Group
Value
95% CI
Marketed Nasal Strip
-7.398
-9.44 – -5.36
Placebo Nasal Strip
-4.194
-6.18 – -2.21
Prototype Nasal Strip
-6.563
-8.71 – -4.42
Sleep time Problems
Group
Value
95% CI
Marketed Nasal Strip
-7.494
-9.99 – -5.00
Placebo Nasal Strip
-5.638
-8.09 – -3.19
Prototype Nasal Strip
-8.212
-10.81 – -5.61
Symptoms on walking in the morning
Group
Value
95% CI
Marketed Nasal Strip
-7.196
-9.28 – -5.11
Placebo Nasal Strip
-4.074
-6.13 – -2.02
Prototype Nasal Strip
-7.905
-10.09 – -5.72
Practical Problems
Group
Value
95% CI
Marketed Nasal Strip
-2.774
-4.02 – -1.52
Placebo Nasal Strip
-2.277
-3.51 – -1.04
Prototype Nasal Strip
-3.079
-4.38 – -1.78
Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14Primary· At Baseline and Day 14
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 unrefres
Sleep Problems
Group
Value
95% CI
Marketed Nasal Strip
-7.624
-9.68 – -5.57
Placebo Nasal Strip
-5.738
-7.74 – -3.74
Prototype Nasal Strip
-7.051
-9.21 – -4.89
Sleep Time Problems
Group
Value
95% CI
Marketed Nasal Strip
-8.746
-11.24 – -6.26
Placebo Nasal Strip
-7.051
-9.49 – -4.61
Prototype Nasal Strip
-6.768
-9.36 – -4.18
Symptoms on waking in the morning
Group
Value
95% CI
Marketed Nasal Strip
-7.858
-9.90 – -5.81
Placebo Nasal Strip
-5.318
-7.33 – -3.30
Prototype Nasal Strip
-8.001
-10.14 – -5.86
Practical Problems
Group
Value
95% CI
Marketed Nasal Strip
-3.591
-4.74 – -2.44
Placebo Nasal Strip
-3.208
-4.34 – -2.07
Prototype Nasal Strip
-3.054
-4.25 – -1.86
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7Primary· At Baseline and Day 7
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or
Group
Value
95% CI
Marketed Nasal Strip
-6.845
-9.28 – -4.41
Placebo Nasal Strip
-5.137
-7.53 – -2.74
Prototype Nasal Strip
-8.184
-10.75 – -5.62
Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14Primary· At Baseline and Day 14
Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or
Group
Value
95% CI
Marketed Nasal Strip
-8.035
-10.34 – -5.73
Placebo Nasal Strip
-5.102
-7.37 – -2.83
Prototype Nasal Strip
-6.917
-9.35 – -4.49
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7Primary· Day 7
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Before strip application
Group
Value
95% CI
Marketed Nasal Strip
32.10
± 22.386
Placebo Nasal Strip
36.37
± 21.945
Prototype Nasal Strip
40.53
± 18.234
After strip application
Group
Value
95% CI
Marketed Nasal Strip
58.95
± 28.543
Placebo Nasal Strip
47.42
± 26.742
Prototype Nasal Strip
61.11
± 21.787
Change from Baseline
Group
Value
95% CI
Marketed Nasal Strip
23.25
± 72.4
Placebo Nasal Strip
8.75
± 24.0
Prototype Nasal Strip
18.89
± 46.6
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14Primary· Day 14
Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Before strip application
Group
Value
95% CI
Marketed Nasal Strip
39.90
± 24.070
Placebo Nasal Strip
43.21
± 24.001
Prototype Nasal Strip
45.89
± 22.292
After strip application
Group
Value
95% CI
Marketed Nasal Strip
68.70
± 26.636
Placebo Nasal Strip
51.05
± 25.387
Prototype Nasal Strip
67.56
± 23.605
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7Primary· Day 7
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.
Before strip removal
Group
Value
95% CI
Marketed Nasal Strip
60.15
± 25.522
Placebo Nasal Strip
46.95
± 25.888
Prototype Nasal Strip
62.63
± 19.774
After strip removal
Group
Value
95% CI
Marketed Nasal Strip
43.10
± 21.711
Placebo Nasal Strip
44.74
± 25.236
Prototype Nasal Strip
60.00
± 21.654
Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.Primary· Day 14
Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy
Before Strip Removal
Group
Value
95% CI
Marketed Nasal Strip
67.80
± 24.816
Placebo Nasal Strip
48.95
± 26.511
Prototype Nasal Strip
70.61
± 22.078
After Strip Removal
Group
Value
95% CI
Marketed Nasal Strip
51.35
± 25.203
Placebo Nasal Strip
45.26
± 25.473
Prototype Nasal Strip
61.11
± 21.978
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7Primary· Day 7
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 application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For 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. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is
Before strip application (Q2)
Group
Value
95% CI
Marketed Nasal Strip
1.75
± 0.550
Placebo Nasal Strip
1.70
± 0.733
Prototype Nasal Strip
1.63
± 0.597
After strip application (Q2)
Group
Value
95% CI
Marketed Nasal Strip
1.00
± 0.795
Placebo Nasal Strip
1.55
± 0.887
Prototype Nasal Strip
1.16
± 0.688
After strip application (Q4)
Group
Value
95% CI
Marketed Nasal Strip
2.80
± 1.399
Placebo Nasal Strip
1.20
± 1.473
Prototype Nasal Strip
1.79
± 1.475
Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14Primary· Day 14
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 application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For 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. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is
Before strip application (Q2)
Group
Value
95% CI
Marketed Nasal Strip
1.40
± 0.598
Placebo Nasal Strip
1.58
± 0.607
Prototype Nasal Strip
1.61
± 0.698
After strip application (Q2)
Group
Value
95% CI
Marketed Nasal Strip
0.85
± 0.875
Placebo Nasal Strip
1.35
± 0.786
Prototype Nasal Strip
1.06
± 0.873
After strip application (Q4)
Group
Value
95% CI
Marketed Nasal Strip
2.70
± 1.658
Placebo Nasal Strip
0.89
± 1.410
Prototype Nasal Strip
2.00
± 1.715
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 9 April 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/NCT01122849.