NCT03105297

To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.

An Exploratory Study of a Nasal Dilator Strip

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.

Detailed description

This study was a baseline-controlled study. This study consisted of three phases: Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), and at Day 30 and 31 (Night 30 and 31 of Nasal resistance phase). Participants wore the Nasal dilator strip during Active phase. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 30 and 31 (Night 30 and 31) where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip" as per there randomization schedule.

Conditions

• Sleep Disordered Breathing
• Congestion, Nasal

Interventions

Type	Name	Description
DEVICE	Prototype nasal dilator strip	External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.
OTHER	No strip

Timeline

• Start date: 2009-09-25
• Primary completion: 2010-08-10
• Completion: 2010-08-10
• First posted: 2017-04-07
• Last updated: 2019-07-26
• Results posted: 2019-07-26

Locations

1 site across 1 country: Australia