The Quantitative Scoring Scale – Nasal Mucosa (QSS-NM): A scale proposed for assessing olfactory mucosa changes following drug administration to the upper nasal space (olfactory epithelium) using a novel delivery device

Oral presentation given at Rhinoworld 2019.

Abstract Authors: Shrewsbury SB, Graber AR, Peroutka S, Davis GE

Objective: To assess upper nasal space mucosa. 

Background: A patient-friendly, self or caregiver actuated device to achieve consistent upper nasal space drug delivery, rapid systemic uptake and higher bioavailability than standard nasal sprays. The Quantitative Scoring Scale – Nasal Mucosa (QSS-NM) was developed, at FDA request, as a physician-administered major component of a comprehensive nasal assessment. 

Method: The QSS-NM developed from the Modified Lund Kennedy Scale (MLKS) for scoring nasal mucosa appearance. Scoring required endoscopy of the roof of the ethmoid sinuses, superior septum, superior attachment of the middle turbinate and the olfactory cleft and scores assigned for each of 5 parameters: (1) mucosal irritation (0: none; 1: focal irritation; 2: superficial mucosal erosion; 3: moderate mucosal erosion; 4: ulceration; 5: septal perforation), and scores of 0-3 for (2) edema (3) discharge (4) crusting (5) epistaxis (0: none; 1: mild; 2: moderate; 3: severe). Each side was scored separately and summed (maximum 17/side) and then total QSS-NM score (maximum 34) for the upper nasal space noted. Scores were used to determine subject eligibility and continuation.  

ResultsEnrollment is expected to complete in April. ~250 baseline endoscopies have been completed, with 430 while on treatment. Results at baseline will be presented.  

Conclusions: The QSS-NM was proposed to act as screening tool (to exclude abnormal upper nasal space mucosa) and assess if drug delivery resulted in any detectable changes. It is being tested in a clinical study of Precision Olfactory Delivery (POD®) of dihydroergotamine for migraine.