Evaluation of Patient Experience for a Computationally-Guided Intranasal Spray Protocol to Augment Therapeutic Penetration: Implications for Effective Treatments for COVID-19, Rhinitis, and Sinusitis

Abstract

Backgroud The nasal route of targeted drug administration facilitates medical management of chronic and acute onsets of various respiratory conditions such as rhinitis and sinusitis and during the initial onset phase of severe acute respiratory syndrome coronavirus 2, when the infection is still contained within the upper airway. Nevertheless, patient comfort issues that are often associated with intranasal devise usage can lead to low compliance, thereby compromising treatment efficacy. Hence, there is an urgent need to detect reproducible and user-friendly intranasal drug delivery modalities that may promote adoption compliance and yet be effective at targeted transport of drugs to the infective airway regions. Methods In this pilot study, we have collected evaluation feedback from a cohort of 13 healthy volunteers, who used an open-angle swirling effect atomizer to assess two different nasal spray administration techniques (with 0.9% saline solution), namely the vertical placement protocol (or, VP), wherein the nozzle is held vertically upright at a shallow insertion depth of 0.5 cm inside the nasal vestibule; and the shallow angle protocol (or, SA), wherein the spray axis is angled at 45° to the vertical, with a vestibular insertion depth of 1.5 cm. The VP protocol is based on current usage instructions, while the SA protocol is derived from published findings on alternate spray orientations that have been shown to enhance targeted drug delivery at posterior infection sites, e.g., the ostiomeatal complex and the nasopharynx. Results All study participants reported that the SA protocol offered a more gentle and soothing delivery experience, with less impact pressure. Additionally, 60% of participants reported that the VP technique caused painful irritation. We also numerically tracked the drug transport processes for the two spray techniques in a computed tomography-based nasal cavity reconstruction; the SA protocol registered a distinct improvement in airway penetration when compared to the VP protocol. Conclusion The participant-reported unequivocally favorable experience with the new SA protocol justifies a full-scale clinical study aimed at testing the related medication compliance parameters and the corresponding therapeutic efficacies.