J ALLERGY CLIN IMMUNOL

FEBRUARY 2012

AB188 Abstracts

MONDAY

710 Effective Nasal Symptom Relief and Improvement in Health-Related Quality of Life in Subjects with Perennial AllergicRhinitis Following 6-Week Once-Daily Treatment withBeclomethasone Dipropionate Hydrofluoroalkane NasalAerosol

W. Carr1, E. O. Meltzer2, A. Finn3, P. M. Dorinsky4, L. Kelley4, S. A.

Dunbar4, S. K. Tantry4; 1Allergy and Asthma Associates of Southern Cal-

ifornia Medical Group, Mission Viejo, CA, 2Allergy and Asthma Medical

Group & Research Center, San Diego, CA, 3National Allergy, Asthma &

Urticaria Centers of Charleston, Charleston, SC, 4Teva Branded Pharma-

ceutical Products R&D, Inc., Horsham, PA.

RATIONALE: Perennial allergic rhinitis (PAR) symptoms are bother-

some and have a major impact on quality of life (QOL). Although

intranasal corticosteroids relieve most allergic rhinitis symptoms and

improve QOL, they are currently available only as aqueous formulations.

This study evaluated the effect of a novel nonaqueous aerosol formulation

of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) on nasal

symptom relief and QOL in subjects with PAR.

METHODS: In this 6-week, double-blind, placebo-controlled, parallel-

group study, subjects were randomized to BDPHFA 320mcg/d (n5236) or

placebo (n5238). The primary efficacy measure was subject-reported

nasal symptoms. Physicians also assessed symptom relief using the

physician-assessed total nasal symptom score (PNSS). Adult subjects

self-assessed their QOL using the Rhinoconjunctivitis Quality of Life

Questionnaire (RQLQ).

RESULTS: At week 6, treatment with BDP HFA resulted in a significant

improvement in RQLQ versus placebo (-0.58 [95% CI: -0.9, -0.2];

P50.001). Moreover, for all 7 individual domains of the RQLQ, improve-

ments from baseline were greater with BDP HFA than with placebo.

Treatment with BDPHFA also resulted in a greater reduction from baseline

in the average PNSS versus placebo (-1.22 [95% CI: -1.7, -0.7]; P<0.001).Greater improvements were also seen for individual physician-assessed na-

sal symptoms (nasal congestion, nasal itching, rhinorrhea, and sneezing)

with BDP HFA than with placebo.

CONCLUSIONS: This study demonstrated that BDP HFA nasal aerosol

provides substantial relief of nasal symptoms and significant improve-

ments in QOL in subjects with PAR. Thus, BDP HFA nasal aerosol should

provide a new and effective treatment option for patients with PAR.

711 Once-Daily Treatment With Beclomethasone DipropionateHydrofluoroalkane Nasal Aerosol (320 mcg/d) Is Not AssociatedWith Hypothalamic-Pituitary-Adrenal Axis Suppression inAdolescent Subjects With Perennial Allergic Rhinitis

F. C. Hampel1, P. H. Ratner2, S. D. Miller3, A. Melchior4, S. A. Dunbar4,

S. K. Tantry4, P. M. Dorinsky4; 1Central Texas Health Research, New

Braunfels, TX, 2Sylvana Research Associates, San Antonio, TX, 3North-

east Medical Research Associates, Dartmouth, MA, 4Teva Branded Phar-

maceutical Products R&D, Inc., Horsham, PA.

RATIONALE: Beclomethasone dipropionate hydrofluoroalkane (BDP

HFA) nasal aerosol is a novel nonaqueous BDP formulation with demon-

strated efficacy in the treatment of allergic rhinitis. The effect of 6 weeks of

treatment with BDP HFA nasal aerosol versus placebo on hypothalamic-

pituitary-adrenal axis function in adult and adolescent subjects with

perennial allergic rhinitis was assessed in this study.

METHODS: In this double-blind, placebo- and active-controlled, paral-

lel-group study, subjects (12-45 years of age) with PAR were randomized

to treatment with BDP HFA 320 mcg/d, placebo, or active-control

(prednisone 10 mg/d). The primary endpoint was change from baseline

in 24-hour serum cortisol weighted mean for BDP HFA versus placebo

after 6 weeks of treatment in all subjects. Results of a subgroup analysis of

adolescent subjects (12-17 years of age; n525) are reported here.

RESULTS: The geometric mean serum cortisol weighted value was

similar in the BDP HFA and placebo treatment groups following 6-week

treatment (ratio of BDP HFA to placebo: 0.92 [95% CI: 0.72, 1.16]) with

little change from baseline in either group. As expected, a>2-fold increasefrom baseline in the geometric mean serum cortisol weighted value was

observed in the placebo/prednisone treatment group (ratio of placebo to

placebo/prednisone: 2.56 [95% CI: 1.76, 3.71]). Results seen in the

adolescent subgroup were similar to those seen for the overall population

for the primary endpoint.

CONCLUSIONS: Twenty-four-hour serum cortisol profiles were com-

parable for BDPHFA nasal aerosol and placebo in adolescent subjects with

PAR, indicating that BDP HFA treatment was not associated with

hypothalamic-pituitary-adrenal axis suppression in adolescent subjects.

712 Once Daily Treatment with Beclomethasone DipropionateHydrofluoroalkane Nasal Aerosol Is Safe and Effective inChildren (6-11 Years of Age) With Seasonal Allergic Rhinitis

N. Segall1, L. Mansfield2, N. Amar3, P. M. Dorinsky4, L. Kelley4, Y.

Ding4, S. K. Tantry4; 1Georgia Allergy & Respiratory, Atlanta, GA, 2Al-

lergy, Immunology & Asthma, El Paso, TX, 3Allergy Asthma Research

Institute, Waco, TX, 4Teva Branded Pharmaceutical Products R&D,

Inc., Horsham, PA.

RATIONALE: An aerosolized intranasal corticosteroid formulation is

desirable for many allergic rhinitis (AR) patients, especially children, who

wish to avoid the ‘‘wet feeling’’ and ‘‘drip down the throat’’ associated with

aqueous formulations. Beclomethasone dipropionate hydrofluoroalkane

(BDP HFA) nasal aerosol, a novel non-aqueous aerosol, has been shown to

be safe and effective in adolescents and adults with AR. This study

evaluated the efficacy and safety of BDPHFA in childrenwith seasonal AR

(SAR).

METHODS: In this 2-week, double-blind, placebo-controlled study, SAR

subjects (6-11 years of age) were randomized to once daily treatment with

BDP HFA 80mcg (n5239), BDP HFA 160mcg (n5242) or placebo

(n5234). The primary endpoint was average AM and PM reflective total

nasal symptom score (rTNSS) over the 2-week treatment period.

RESULTS: The change from baseline in average AM and PM rTNSS was

significantly greater for BDP HFA versus placebo (-0.71 [95%CI: -1.1,

-0.3] for 80mcg; -0.76 [95%CI: -1.1, -0.4] for 160mcg; P<0.001 for both).

Similarly, the change from baseline in average AM and PM instantaneous

TNSS was significantly greater for BDP HFA versus placebo (-0.63 [95%

CI: -1.0, -0.3] for 80mcg; -0.73 [95%CI: -1.1, -0.4] for 160mcg; P<0.001

for both). The safety profile of BDP HFAwas generally similar to placebo.

CONCLUSIONS: These results demonstrate that BDPHFA nasal aerosol

provides significant nasal symptom relief in pediatric SAR subjects. These

results indicate that BDPHFA nasal aerosol should provide a new effective

and well-tolerated treatment option for pediatric SAR patients.