J ALLERGY CLIN IMMUNOL

VOLUME 125, NUMBER 2

Abstracts AB103

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405 Validation of the Rhinitis Control Assessment Tool (RCAT) In AManaged Care Organization (MCO)

M. Schatz1, S. Yang1, W. Chen1, C. Garris2, M. Corrao2, R. Stanford2,

R. Zeiger1; 1Kaiser Permanente, San Diego, CA, 2GlaxoSmithKline,

Research Triangle Park, NC.

RATIONALE: RCAT is a recently developed six-question clinical tool

lacking extensive published validation information.

METHODS: Members of a large MCO with an encounter diagnosis of rhi-

nitis on a visit in the past 2 years were recruited for this study

(FFU111254). Questionnaires were mailed to patients in September,

2008 and January, 2009. RCAT scores range from 6-30; higher scores in-

dicate better rhinitis symptom control. Construct validity was assessed

by correlation of the RCAT score with the Mini Rhinitis Quality of Life

Questionnaire (RQLQ) and the relationship to prior missed work/school.

Predictive validity was assessed by the relationship of the RCAT score to

subsequent reported rhinitis medication use/effectiveness.

Responsiveness was assessed by correlating the change in RCAT with

the change in RQLQ.

RESULTS: Baseline and follow-up surveys were completed by 1,051 and

836 patients respectively. RCAT was strongly correlated at baseline with

total RQLQ (Spearman rho 5 -0.82, p < 0.0001) and with individual

RQLQ domains (rho ranges from -0.61 to -0.77, p < 0.0001). Mean [sd]

RCAT was significantly lower (p < 0.0001) in patients who did (18.5

[4.0]) versus did not (21.0 [4.0]) report missed work/school due to rhinitis

in the prior 3 months. Lower mean baseline RCAT was associated (p <

0.0001) with increased use and decreased effectiveness of rhinitis medica-

tions reported at the follow-up survey. Change in RCAT correlated signif-

icantly (p < 0.001) with change in total RQLQ from baseline to follow-up

(rho 5 -0.61).

CONCLUSIONS: RCAT is a valid and responsive tool to assess rhinitis

control in the MCO population.

406 The Allergic Rhinitis Questionnaire (ARQ): A Valid andReliable Measure of Symptom Severity (SS) in AllergicRhinitis (AR)

D. Schull1, S. G. Reddy2, D. Khan2; 1Parkland Health and Hospital

Systems, Dallas, TX, 2University of Texas Southwestern Medical Center,

Dallas, TX.

RATIONALE: Several instruments have been developed to capture symp-

toms and quality of life effects due to rhinitis. We sought to develop and

validate a new instrument to measure multiple parameters regarding AR

using a brief questionnaire.

METHODS: Following a pilot study to test for reliability and content va-

lidity, the ARQ was tested on a purposive sample of 200 patients with AR.

The redesigned instrument contained 2 Likert scales measuring nasal and

non nasal symptoms, and 3 visual analog scales: Quality of Life,

Medication Efficacy and Severity of Disease. A total of 13 items.

Reliability for the ARQ was determined using Cronbach’s coefficient al-

pha. Principal axis factor analysis with varimax rotation was conducted

to assess the construct validity of the ARQ.

RESULTS: The Cronbach’s coefficient alpha for the ARQ was 0.89 mea-

suring reliability. The factor analysis was designed to index 3 constructs:

nasal symptoms, non-nasal symptoms and severity. After rotation, the first

factor accounted for 21.8% of the variance, the second factor accounted for

20.2%, and the third factor accounted for 13.3%.

CONCLUSIONS: Our study of a new questionnaire for measuring SS in

AR demonstrates sufficient reliability and validly for a new instrument.

Furthermore, the length of the questionnaire is only 2 pages, greatly in-

creasing the usefulness of the ARQ as both a quick and accurate measure

of AR symptom severity.

407 Production of an Acute and Late-Phase Response in AllergicRhinitis in an Allergen BioCube

M. B. Abelson1,2, P. Gomes1, R. Chaturvedi1; 1Ora, Inc, Andover, MA,2Schepens Eye Research Institute, Boston, MA.

RATIONALE: Some patients exhibit a pronounced late-phase allergic re-

sponse, characterized by residual symptoms several hours after allergen

exposure and development of a hyper-reactivity to allergen. An Allergen

BioCube has been developed that produces the full spectrum of allergic rhi-

nitis symptomatology.

METHODS: A 5 visit, single-center, IRB approved, pilot Allergen

BioCube study was conducted. Subjects with a history of allergic rhinitis

and positive skin test reaction to ragweed entered the BioCube 4 consecu-

tive days. Fourteen subjects were enrolled and attended at least three visits.

Nasal allergic symptoms (pruritis, rhinorrhea, sneezing, and congestion)

were subjectively assessed every 15 minutes, using standardized 0-3 unit

scales and were combined for the total nasal signs and symptoms

(TNSS) score. Each day, subjects remained in the chamber for up to 2

hours, or until a positive response (TNSS � 6) occurred.

RESULTS: Fourteen subjects were enrolled and attended at least three

visits. Eight (57.1%) subjects showed a positive TNSS response at one

or more time points, with a mean peak TNSS of 9.13. Seven (87.5%) sub-

jects demonstrated a late phase reaction on visits 2-4 with a mean TNSS

increase of 2.00 from visit 1-4 prior to allergen exposure. These seven sub-

jects also exhibited hyper-reactivity, as the mean peak TNSS score in-

creased by 2.29 from visits 1-4 and the mean time required for a positive

reaction in the BioCube decreased from 55.7 min at visit 2 to 38.6 min

at visit 3.

CONCLUSIONS: The Allergen BioCube is an effective and reproducible

model for identifying subjects with acute and late-phase allergic rhinitis.

408 Changes in Nasal Nitric Oxide After Allergen Challenge -Relation to Nasal Blockage

D. Tworek, I. Bogus-Buczynska, I. Kuprys-Lipinska, P. Kuna; Barlicki

University Hospital, Medical University of Lodz, Lodz, POLAND.

RATIONALE: Changes in nasal nitric oxide (nNO) levels after nasal al-

lergen challenge and their usefulness in evaluation of the outcome of the

challenge have not been determined in details.

METHODS: 23 allergic subjects and 22 non-allergic controls were in-

cluded. All subjects underwent allergen challenge preceded by placebo ad-

ministration. Visual Analogue Scale (VAS), nNO and peak nasal

inspiratory flow (PNIF) were determined before and 30 minutes after pla-

cebo and allergen administration.

RESULTS: Significant fall in nNO levels was observed in allergic patients

after allergen challenge (p<0,001), but not after administration of placebo

(p>0,05). No changes in nNO were observed in non-allergic subjects dur-

ing the challenge (p>0,05). The change in nNO correlated with changes in

PNIF and nasal blockage VAS score (R50,7; p<0,001 and R5-0,42;

p50,046; respectively), but not with change in total VAS score after aller-

gen challenge (R5-0,24; p50,26).

CONCLUSIONS: Fall in nNO after allergen challenge is associated with

decreased nasal flow. Further studies are necessary to determine if this phe-

nomenon may be useful in evaluation of allergen challenge outcome.