NCT03549130

A Pivotal Study to Assess the Effectiveness of Nasal Dilator (Breathe Right Nasal Strips)

Pivotal Subjective Sleep Study of a Nasal Dilator

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study had a screening phase, a one-week baseline qualification and a two-week treatment phase. Participants who met the entrance criteria, who were currently 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 VAS on at least four of seven qualification nights were randomized to one of two treatments for use at home. During the two-week in-home treatment phase, daily diaries measuring the perception of nasal breathing and nasal congestion using a VAS were completed. 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 NRQLQ, measured response.

Conditions

• Congestion, Nasal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-11-04
• Primary completion: 2011-02-17
• Completion: 2011-02-17
• First posted: 2018-06-07
• Last updated: 2018-09-25
• Results posted: 2018-09-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study