Abstract
This exploratory study investigated effects of a new asymmetric butterfly-shaped prototype nasal dilator strip and the currently marketed clear Breathe Right Nasal Strip (BRNS) on subjective measures of nasal congestion and sleep quality. In this randomized, double-blind study, subjects with chronic nasal congestion and sleep difficulties were assigned a BRNS clear strip, an asymmetric butterfly prototype, or an asymmetric butterfly placebo strip without springs, to use nightly for 2 weeks. The main outcomes included change from baseline to days 7 and 14 on the Pittsburgh Insomnia Rating Scale (PIRS), Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), and Congestion Quantifier Seven-Item Test (CQ7). The intent-to-treat population included 59 subjects. The butterfly and BRNS strips showed significant (P < 0.05) improvement versus placebo on PIRS satisfaction with sleep at day 7 [least square (LS) mean changes: - 0.7, - 0.6, and - 0.2, respectively], and the butterfly strip also showed significant improvement from baseline on this outcome versus placebo at day 14 (- 1.0 vs - 0.5). On the NRQLQ, both the butterfly prototype and BRNS clear were more effective than placebo in improving symptoms on waking at day 7 (...Continue Reading
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