Safety and tolerability of surfactant nasal irrigation

Background

Abnormal mucus composition and bacterial biofilms are thought to contribute to the pathophysiology of rhinosinusitis. Addition of a mucoactive surfactant to saline irrigation solution has been hypothesized to address these factors. We evaluated the safety and tolerability of a reformulated surfactant in a sample of normal subjects.

Methods

A total of 33 volunteers were randomly assigned to receive either surfactant solution or buffered saline at baseline in a controlled crossover study design. Each subject underwent rhinoscopic exam and in-office smell testing via the 40-question smell identification test (SIT). Those with non-normosmic results or active rhinitis symptoms were excluded. Subjects were instructed to irrigate twice daily with the selected solution for 1 week while keeping a daily diary. For week 2, treatment was stopped. During week 3, each group switched to the other treatment. Exam, SIT, and degree of congestion were assessed after each phase.

Results

Use of surfactant led to a marginal reduction in mean SIT score of 1.5 points, which was statistically significant (p = 0.012). A clinically meaningful reduction in SIT score, defined as ≥4 points, was observed in 18% (6/33) of subjects after surfactant vs 3% (1/33) after saline (p = 0.046). During the surfactant phase, moderate or severe congestion was reported in 29% (8/28) of subjects completing the diary. In contrast, only 6% (2/32) of subjects reported moderate congestion after the saline phase (p = 0.021).

Conclusion

In normal volunteers, surfactant nasal irrigation may be associated with tolerability issues due to congestion. A subset may experience reduction in olfactory acuity that appears reversible.

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