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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 is a Phase 2 study of Congestion, Nasal that has completed, run by GlaxoSmithKline. The registered enrollment target is 140 participants. The trial reports 2 study locations across 2 states.
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)".
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549117
The ClinicalTrials.gov registry entry for NCT03549117 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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