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.