Outcome Measures
The primary outcome measure of this study was reduction in endoscopic nasal polyp score at 20 weeks after the first injection compared to baseline. The total bilateral polyp score (0-8) is the sum value from each nostril as used by others(15, 20) and graded based on polyp size: 0, no polyps; 1, small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2, polyps reaching below the lower border of the middle turbinate; 3, large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4, large polyps causing complete obstruction of the inferior meatus. Endoscopy video scores were determined independently by two blinded investigators. Discrepancies were resolved with a third independent and blinded tiebreaking investigator.
Secondary endpoints included: 1) changes the Lund-Mackay (LMS) computed tomographic (CT) scan score, which determines the degree of sinus obstruction on a scale of zero to twelve (bilateral score 0-24)(21); 2) the Sino-Nasal Outcome Test (SNOT-22) clinical survey (measured from 0-110); 3)the nasal blockage score (NBS) (score 0-5); and 4) sensation of smell evaluated using the University of Pennsylvania Smell Identification Test (UPSIT) which includes 40 common smells imbedded on individual scratch and sniff testing cards. All outcomes were determined by a blinded investigator.
Other important outcomes included precise determination of allergic sensitization by skin prick testing, rescue medication use, laboratory evaluation of CBC, basic chemistry, electrolytes, LFTs and total serum IgE. The UniTest PC (Lincoln, Diagnostics, Decatur, IL) was used as a disposable skin test device.(22, 23) Allergens used for testing included several trees, grasses, weeds, molds, dust mite, cat, dog, mouse and cockroach (HollisterStier, Spokane, WA; Greer Laboratories, Lenoir, NC; ALK-Abello, Round Rock, TX). A short wave infrared camera (AllergyScope, Flare Diagnostics, Baltimore, MD) was used as a skin colour agnostic tool to determine the precise SPT wheal dimensions as per methods previously described.(24) A positive SPT was defined as a wheal of at least 3mm diameter and at least 2mm greater than the negative control.
Safety was evaluated by vital sign measurements, physical examination, laboratory assessment, and continuous adverse events reporting.