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NCT03549117 · ClinicalTrials.gov registry record · Phase 2
A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)
A Phase 2 study of Congestion, Nasal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT03549117: Completed Phase 2 study of Congestion, Nasal, sponsored by GlaxoSmithKline.
NCT03549117 is a Phase 2 study of Congestion, Nasal that has completed, run by GlaxoSmithKline. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549117, a Phase 2 study of Congestion, Nasal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized, double-blind, parallel group, placebo-controlled study assessed the effects of a novel nasal dilator strip in consumers with chronic nocturnal nasal congestion who have trouble with their sleep. Participants who met the entrance criteria were suffering from nasal congestion every night or almost every night, 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 where they self-administered the validated subjective questionnaire "the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)".
Primary Outcome
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/thr
Conditions Studied
Interventions
- DEVICE Breathe Right Tan (small/medium) nasal strips
- OTHER Placebo nasal strip
Study Locations (2)
New Jersey
- Essex Testing Clinic, Inc - Verona
Ohio
- Radiant Research - Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2010-10-25 |
| Est. Completion | 2011-01-14 |
| Phase | Phase 2 |
What the finished NCT03549117 record still lists
NCT03549117 is an interventional study that assigns participants to a tested intervention. The registered 140 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 1 condition, with Congestion, Nasal appearing as the primary indexed condition, and to 2 interventions - of which Breathe Right Tan (small/medium) nasal strips is the first listed.
NCT03549117 reports a single indexed study location in New Jersey, Ohio.
Frequently Asked Questions
What is clinical trial NCT03549117 about?
NCT03549117 is a clinical study titled "A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)". This randomized, double-blind, parallel group, placebo-controlled study assessed the effects of a novel nasal dilator strip in consumers with chronic nocturnal nasal congestion who have trouble with their sleep. Participants who met the entrance criteria were suffering from nasal congestion every ni...
What is the current status of trial NCT03549117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2010-10-25. Estimated completion is 2011-01-14.
What conditions does trial NCT03549117 study?
This clinical trial studies the following conditions: Congestion, Nasal.
What interventions are being tested in trial NCT03549117?
The interventions under investigation include: Breathe Right Tan (small/medium) nasal strips (DEVICE), Placebo nasal strip (OTHER).
Who is sponsoring clinical trial NCT03549117?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549117 being conducted?
This trial has 2 study locations across New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03549117's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 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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