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NCT03549130 · ClinicalTrials.gov registry record · Phase 2
A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT03549130: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT03549130 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549130, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 o
Interventions
- DEVICE Breathe Right Tan (small/medium) nasal strips
- OTHER Placebo nasal strip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2010-11-04 |
| Est. Completion | 2011-02-17 |
| Phase | Phase 2 |
What the finished NCT03549130 record still lists
NCT03549130 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Breathe Right Tan (small/medium) nasal strips is the first listed.
NCT03549130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03549130 about?
NCT03549130 is a clinical study titled "A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)". 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 suffer...
What is the current status of trial NCT03549130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2010-11-04. Estimated completion is 2011-02-17.
What interventions are being tested in trial NCT03549130?
The interventions under investigation include: Breathe Right Tan (small/medium) nasal strips (DEVICE), Placebo nasal strip (OTHER).
Who is sponsoring clinical trial NCT03549130?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03549130's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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