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A Pivotal Subjective Sleep Study of a Nasal Dilator (Breathe Right Tan)

NCT03549117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-09-25

Study results available
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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

  • Congestion, Nasal

Interventions

DEVICE

Breathe Right Tan (small/medium) nasal strips

Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (Breathe Right Tan), small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks

OTHER

Placebo nasal strip

Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips, small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-25
Primary Completion
2011-01-14
Completion
2011-01-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549117 on ClinicalTrials.gov