Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Abstract

Background: External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated.

Objective: To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures.

Methods: Two studies were conducted separately in healthy volunteers ≥18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecutive nights of use, using the Dermal Response Scale (DRS) and subject-reported comfort and ease of removal.

Results: In the Patency study (N = 50), all 3 strips demonstrated significant improvement from baseline in MCA, nasal volume, and nasal flow parameters (resistance and peak flow). The prototype strips demonstrated significantly more improvement in nasal volume than the BRNS, and the butterfly strip showed significantly more improvement in MCA than the BRNS; all strips were similar with respect to nasal flow and subject-reported nasal breathing outcomes. In the Dermal Tolerability study (N = 82), all subjects scored 0 (no evidence of irritation) on the DRS at all 7 morning assessments; the BRNS was numerically, but not significantly, superior to the butterfly strip on subject-reported outcomes.

Conclusion: The Patency study demonstrated significant improvement from baseline in nasal dimensions and flow for all 3 evaluated strips; between-strip differences were confined to nasal dimensions. Both the BRNS and butterfly strip were generally well tolerated, with no evidence of dermal response over 7 consecutive nights of use.ClinicalTrials.gov identifiers: NCT01105949 and NCT01495494.

Keywords: Dermal Response Scale; acoustic rhinometry; external nasal dilator strip; nasal breathing; nasal inspiratory flow; nasal patency; nasal resistance; nonpharmacologic therapy; posterior rhinomanometry; subject-reported outcomes.

Figures

Figure 1.

Acoustic Rhinometry Results From the Patency Study (ITT Population). BRNS, Breathe Right nasal strip; ITT, intent-to-treat; MCA, minimum cross-sectional area. aMean change was adjusted for baseline, with baseline used as a covariate in the model. Baseline values for MCA (second restriction) were 0.89, 0.88, and 0.91 cm2 for the BRNS, asymmetric butterfly, and teardrop strip, respectively, and for volume of the first 3 cm were 4.27, 4.29, and 4.26 cm3, respectively. bP < .0001 versus baseline. cP = .003 versus BRNS. dP < .0001 versus BRNS.

Figure 2.

Subject-Reported Measures From the Patency Study (ITT Population): (A) Adjusted Mean Percentage Change in Ease of Breathing VAS Rating and (B) Mean Numerical Rating of How Breathing Feels With the Strip Applied. BRNS, Breathe Right nasal strip; ITT, intent-to-treat; VAS, visual analog scale. aMean change was adjusted for baseline, with baseline values used as a covariate in the model. bP < .0001 versus baseline; neither prototype was statistically significantly different versus the BRNS on either the VAS or the numerical rating scale. cResponses on a 0 to 100 mm visual analog scale (0 = extremely difficult, 100 = extremely easy). dResponses on an 11-point numerical rating scale (−5 = much worse, 0 = no difference, 5 = much better).

Figure 3.

Overnight Nasal Strip Detachment (≥2 of 4 Sides Lifted), Dermal Tolerability Study. Percentages of subjects who reported various degrees of nasal strip detachment (2 of 4 sides lifted [blue], 3 of 4 sides lifted [red], or completely detached [green]) upon awakening throughout the 7-day study (left side) and during study days 4 to 7 (right side). The remaining subjects in each group reported complete nasal strip attachment (4 of 4 sides attached) upon awakening. BRNS, Breathe Right nasal strip.