899 A Real World Open-label Multicenter Single Group Study toEvaluate Patients' Reactions to Mucinex (Single Entity Long-acting Guaifenesin)

W. W. Storms1, M. A. Kaliner2, M. Javidi3, J. R. Farrar4, C. S. Efessiou5;1The Williams Storms Allergy Clinic, Colorado Springs, CO, 2The Insti-

tute for Asthma and Allergy, Wheaton and Chevy Chase, MD, 3North Car-

olina State University, Raleigh, NC, 4SRxA Institute for Professional

Education, Washington, DC, 5Strategic Pharmaceutical Advisors, Inc.,

Washington, DC.

RATIONALE: Although guaifenesin has been used to treat respiratory

conditions for years, clinical data remain limited. The efficacy of a new

quick-release/long-acting, single-entity guaifenesin (Mucinex) was as-

sessed for mucus-related respiratory conditions.

METHODS: This open-label trial, conducted by 87 physicians, enrolled

patients with upper or lower respiratory conditions. A physician question-

naire recorded diagnosis and treatment; a patient enrollment questionnaire

evaluated pre-treatment respiratory symptoms and medication usage.

Patients were treated for 7 days with Mucinex (2-600 mg tablets BID)

plus usual care. Symptoms scores (0 5 none, 10 5 worst possible) were

recorded daily along with Mucinex use; a recall questionnaire was com-

pleted by interview on Day 7. The primary endpoint was patient-reported

improvement. Adverse events were recorded independently.

RESULTS: Completed interviews (n5791), data analyzed at time of

abstract submission (n5595). Patients (14-92 yr) reported mucus-related

symptoms: cough (75.1%), excess mucus (68.7%), nasal congestion

(67.6%), thick mucus (55.3%), chest congestion (54.6%), sinus pain/pres-

sure (52.8%), and/or runny nose (50.8%); <15% were using medications.

Physicians’ diagnoses included chest congestion (31.1%), sinusitis

(29.2%), bronchitis (28.7%), nasal congestion (28.2%), rhinitis (22.4%).

Mucinex usage was associated with average improvements from baseline

in chest congestion (56.7%), nasal congestion (48.4%), difficulty clearing

mucus (45.0%), day-cough (48.8%), and night-cough (50.0%). On Day 7

the %patients with symptoms scores �2 increased from baseline by

35.4%, 42.8%, 53.2%, 42.4%, 44.8%, respectively. Patient ratings of over-

all health increased by 51.4% from Day 1 to Day 7.

CONCLUSION: One week’s treatment of respiratory illnesses with

Mucinex significantly improved mucus-related symptoms and overall fee-

lings of health.

900 Patient Comparison of Sensory Attributes of Olopatadine andAzelastine Nasal Sprays

E. O. Meltzer1, W. E. Berger2, S. J. Chadwick3, G. Gross4, C. F. LaForce5,

R. Garadi6, K. Crenshaw6, G. M. Wall6; 1Allergy & Asthma Medical

Group & Research Center, San Diego, CA, 2Allergy & Asthma Associates

of Southern California, Mission Viejo, CA, 3ENTA Allergy, Head & Neck

Institute, Decatur, IL, 4Pharmaceutical Research and Consulting, Inc.,

Dallas, TX, 5North Carolina Clinical Research, Raleigh, NC, 6Alcon

Research, Ltd., Fort Worth, TX.

RATIONALE: Sensory attributes of nasal sprays may affect patient com-

pliance with treatment regimens. This study compared patient perceptions

of sensory attributes including taste and aftertaste of olopatadine nasal

spray (OLO) to azelastine nasal spray (AZ) (Astelin�).

METHODS: Patients 18 years or older with a 2-year history of allergic

rhinitis who were symptomatic at enrollment were treated with OLO and

AZ nasal sprays in a prospective, randomized, double-masked, multi-

site, crossover study. Patients received one dose (two sprays per nostril)

of each test article, with 2462 hours washout between the treatments.

Patients self-rated the attributes of each treatment (immediately and 45

minutes post-dose) and completed a product comparison at the end of study

using a validated questionnaire. Primary endpoint was the aftertaste pref-

erence at the end of study. Secondary endpoints included satisfaction

with sensory attributes (immediate taste, aftertaste) and product preference

(overall preference, likelihood of use). Safety evaluation was based on

adverse events.

RESULTS: One hundred ten patients of ages 18 to 72 years were enrolled

into the study. OLO was statistically superior to AZ (p50.0005) for

aftertaste at the end of study, with 60.6% preferring OLO over AZ. OLO

was also superior to AZ for satisfaction with immediate taste

(p<0.0001), overall preference (p50.0001), and preference for likelihood

of use of the product (p50.0004). OLO was numerically, but not statisti-

cally (p50.3150) superior to AZ for satisfaction with aftertaste 45 minutes

post-dose.

CONCLUSIONS: Patients preferred OLO over AZ based on taste and af-

tertaste and would be more likely to use OLO nasal spray given the choice.

Funding: Alcon Research, Ltd.

901 Acoustic Rhinometry And Symptoms Score Evaluation DuringThe Treatment With Desloratadine In Pediatric Patients WithAllergic Rhinitis

A. B. F. Fomin, A. G. A. Oliveira, A. C. Pastorino, C. M. A. Jacob; Fac-

ulty of Medicine of University of Sao Paulo, Sao Paulo, BRAZIL.

RATIONALE: Allergic rhinitis (AR) is very common in pediatric popu-

lation and the nasal obstruction, created by nasal mucosal inflammation,

is the most important symptom that impairs the quality of life. The

newer-generation antihistamines have been used by their antiallergenic ef-

fects and anti-inflammatory properties. We evaluated the effects of deslor-

atadine on the symptoms of allergic rhinitis by acoustic rhinometry and

symptoms score.

METHODS: 27 patients (11F:16M), age between 12 to 18 years were in-

cluded with chronic persistent AR (ARIA criteria) and initial total symp-

toms score �3 (ranged 0 to 12). The acoustic rhinometry was made by

Rhinoscan (Rhinometrics AS/Denmark) according Djupesland, 2000.

After 21 days of the wash out period, all patients received 5 mg of de-

sloratadine once daily. The symptoms were evaluated and recorded by

patients daily in symptoms diary. They were followed during 90 days.

We excluded patients that required more than 3 days of rescue

medication.

RESULTS: There was a statistically significant improvement of the aver-

age of total symptoms score in 2nd and 3rd month (p50,002 and p5 0,

00017 respectively), especially the nasal obstruction in the 3rd month

(p50, 0004). There were a statistically improvement of the MCA2 in 30

days (p50, 02) and VOL1 in 90 days (p50, 04).

CONCLUSION: The newer-generation antihistamines can have a place in

the management of persistent allergic rhinitis and in the amelioration of

specific symptoms as nasal obstruction.

Funding: Industria Quimica e Farmaceutica Schering-Plough S.A.

J ALLERGY CLIN IMMUNOL

VOLUME 119, NUMBER 1

Abstracts S229

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