CONCLUSIONS: Desloratadine therapy, with or without concomitant

corticosteroids, was highly effective in the treatment of allergic rhinitis

in children aged 6 to 12 years. It was also safe and well tolerated.

Funding: Schering-Plough

251 Mometasone Furoate Nasal Spray Rapidly and EnduringlyRelieves Nasal Congestion and Other Symptoms of SeasonalAllergic Rhinitis

G. N. Gross1, M. R. Danzig2, D. Gates2; 1Dallas Allergy and Asthma Cen-

ter, Dallas, TX, 2Schering-Plough Research Institute, Kenilworth, NJ.

RATIONALE: As one of the most bothersome symptoms of seasonal al-

lergic rhinitis (SAR), congestion frequently interferes with sleep, daytime

productivity/alertness, and quality of life.

METHODS: This retrospective analysis of the onset and duration of effi-

cacy of mometasone furoate nasal spray (MFNS) 200 mcg once daily over

15 days was based on pooled study data from 4 randomized, double-blind,

placebo-controlled clinical trials in subjects with SAR. Subjects rated each

symptom, including congestion, on a scale of 0 (none) to 3 (severe).

Symptom severity ratings for the Total Nasal Symptom Score (TNSS)

were categorized as mild (<6), moderate (6-<10), or severe (�10).

RESULTS: Mean baseline scores were similar for the MFNS (n5492) and

placebo (n5497) groups for congestion (2.24 and 2.25, respectively) and

TNSS (7.71 and 7.78, respectively). Treatment with MFNS produced

significantly greater improvements than placebo in congestion and TNSS

beginning on Day 2 and continuing on every day of the 15-day treatment

period. At Day 2, score decreases with MFNS and placebo, respectively,

were -0.36 vs -0.21 (-13.6% vs -7.7%; P<0.001) for congestion and

-1.49 vs -0.81 (-16.5% vs -8.1%; P<0.001) for TNSS. At Day 15, decreases

in scores with MFNS and placebo, respectively, were -0.82 vs -0.44

(-34.5% vs -17.2%; P<0.001) for congestion and -3.52 vs -1.94 (-41.6%

vs -21.8%; P<0.001) for TNSS.

CONCLUSIONS: MFNS rapidly improved congestion and total nasal

symptoms in subjects with SAR, with significant improvements by Day

2 of treatment that continued for the duration of the study.

Funding: Schering-Plough

252 Desloratadine Treatment Improves Symptoms in PatientsWith Seasonal Allergic Rhinitis

I. Braverman1, M. Beiser2, Z. Gilad3; 1Hillel Yaffe Medical Center,2

J ALLERGY CLIN IMMUNOL

JANUARY 2007

S64 AbstractsSA

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RD

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249 Improved Symptom Relief and Quality of Life WithDesloratadine in Pollen-Induced Allergic Rhinitis

D. Dumitrascu; University of Medicine and Pharmacy Iuliu Hatieganu,

Cluj Napoca, ROMANIA.

RATIONALE: To evaluate once-daily desloratadine therapy in patients

with pollen-induced allergic rhinitis.

METHODS: In a multicenter, open-label study, 496 patients with pollen-

induced allergic rhinitis were treated with desloratadine 5 mg/day for 14

days. Three visits were scheduled: one within 30 days before patients en-

tered the study (V1), one at baseline (V2), and one at the end of study (V3).

Symptom scores were assessed at V2 and V3 on a scale of 0 to 3 (where

05no symptoms and 35severe symptoms). Patients also rated quality of

life using the Mini Rhinoconjunctivitis QOL Questionnaire

(MiniRQLQ), where 05unaltered and 65extremely altered.

RESULTS: After 14 days of desloratadine treatment, the total symptom

score decreased from 9.68 6 2.55 to 1.85 6 1.97 (P<0.001). Each individ-

ual symptom scores also decreased significantly (P<0.001), as follows:

secretion, from 2.19 6 0.67 at baseline to 0.55 6 0.62 at the end of

treatment; nasal congestion, from 2.27 6 0.63 to 0.58 6 0.66; sneezing,

from 2.09 6 0.72 to 0.29 6 0.52; nasal itching, from 1.74 6 0.83 to

0.23 6 0.47; ocular symptoms, from 1.41 6 0.92 to 0.2 6 0.44.

Therapeutic remissions occurred in 36.4% of patients, and an additional

54.9% had marked improvement in their rhinitis. QoL scores improved

from 27.75 6 16.30 at V2 to 4.6 6 16.3 at study end (P<0.001).

Twenty-four patients reported adverse events (AEs), but all were mild

and no patients discontinued the study due to AEs.

CONCLUSIONS: Desloratadine was highly effective in relieving symp-

toms and improving QoL in patients with pollen-induced allergic rhinitis.

Funding: Schering-Plough Romania

250 Efficacy and Safety of Desloratadine in Combination withMometasone Furoate in Patients With Moderate-to-Severe SAR

G. Grevers1, B. Karmann2; 1Nose and Sinus Center, Starnberg, GER-

MANY, 2Medical Affairs, Essex Pharma GmbH, Munich, GERMANY.

RATIONALE: To evaluate the efficacy and safety of oral desloratadine in

combination with intranasal mometasone furoate in patients with moder-

ate-to-severe seasonal allergic rhinitis (SAR).

METHODS: Patients with nasal and ocular symptoms of SAR (N53752)

were treated with desloratadine 5 mg/day plus mometasone furoate 200

mg/day. Up to 3 visits were scheduled: one at the start of treatment, one (op-

tional) visit during therapy, and a final visit at the end of treatment (average

duration of therapy: 31.4 6 21.2 days). Individual symptom severity and

sleep disturbance were rated on a 4-point scale (05no symptoms;

35severe symptoms). Primary efficacy parameters were change in mean

summed total nasal symptom score (TNSS) and change in mean summed

total ocular symptom score (TOSS) over the course of the study. Sleep dis-

turbances were also assessed.

RESULTS: TNSS decreased from 8.54 at baseline to 2.1 at endpoint

(P<0.0001), and TOSS decreased from 4.64 to 0.97 (P<0.0001). Nasal

congestion also improved with treatment. Improvement was seen in the

percentage of patients experiencing problems falling asleep (79.5% at

baseline vs 34% at endpoint), nocturnal awakening (74.2% vs 26.2%),

and missing nocturnal sleep (67.4% vs 20.7%). Treatment was associated

with a decrease in total sleep disturbance score from an average of 6.27 6

4.73 at visit 1 to 1.61 6 3.25 at visit 3, with a mean intra-individual

improvement of 4.7 6 5.02 (P<0.0001). The overall treatment-related ad-

verse event rate was 0.88%.

CONCLUSIONS: Desloratadine plus mometasone furoate was highly

effective in controlling nasal and ocular symptoms and sleep disturbance

in patients with moderate-to-severe SAR.

Funding: Essex

Hadera, ISRAEL, The Tel Aviv Sourasky Medical Center, Tel Aviv,

ISRAEL, 3Schering-Plough Israel AG, Petach Tikva, ISRAEL.

RATIONALE: To evaluate symptom improvement with desloratadine

therapy in patients with seasonal allergic rhinitis (SAR).

METHODS: In a multicenter, open-label study, 63 adult patients with

SAR were treated with desloratadine. Three visits were scheduled (average

duration of therapy: 27 6 7 days). Efficacy was measured by improvement

in SAR symptoms (nasal discharge, nasal congestion, sneezing, nasal itch-

ing, and ocular symptoms) and a favorable global therapeutic response.

Patients also rated quality of life using the Mini Rhinoconjunctivitis

QOL Questionnaire (MiniRQLQ); components were daily activities, prac-

tical problems, nasal and ocular symptoms, and other systems (eg, thirst).

RESULTS: At the end of desloratadine treatment, the percentage of pa-

tients reporting moderate or severe nasal discharge was reduced from

83% at baseline to 21% at final visit. Nasal congestion was reduced from

97% to 24%; sneezing from 75% to 21%; nasal itching from 86% to

22%; and ocular symptoms from 71% to 10% (P<0.0001 for all).

Improvement in quality of life (QoL) was also noted, as indicated by reduc-

tion in all MiniRQLQ scores (P<0.0001 in all categories). The greatest im-

provements were seen in problems with stuffy nose, sneezing, and the need

to blow nose repeatedly. Seventy-one percent of patients reported marked

relief or total relief with desloratadine treatment, while only 14% reported

no relief. There were 9 reports of adverse events (AEs); none were serious.

Five patients discontinued the study due to dry throat, somnolence, consti-

pation, urgency, or headache.

CONCLUSIONS: Desloratadine was safe and effective in relieving SAR

symptoms and improving patient QoL.

Funding: Schering-Plough