Abstract
INTRODUCTION: Two multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping. METHODS: Subjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). RESULTS: A total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ "Sleep Problems" domain or the "Feel Tired and Unrefreshed" item of the "Symptoms on Waking in the Morning" domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated. CONCLUSIONS: BRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect. FUNDING: GlaxoSmithKline Consumer Healthcare. CLINICALTRIALS. GOV REGISTRATION NUMBERS: Study 1: NCT03549117; Study 2: NCT03549130.