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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 130 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549130
The ClinicalTrials.gov registry entry for NCT03549130 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 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 0 conditions, and to 2 interventions - of which Breathe Right Tan (small/medium) nasal strips is the first listed.
NCT03549130 reports 0 study locations.
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.
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