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Improved Symptom Relief and Quality of Life With Desloratadine in Pollen-Induced Allergic Rhinitis
S64 Abstracts
SATURDAY
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
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Improved Symptom Relief and Quality of Life With Desloratadine 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 polleninduced allergic rhinitis were treated with desloratadine 5 mg/day for 14 days. Three visits were scheduled: one within 30 days before patients entered 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 individual 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 symptoms and improving QoL in patients with pollen-induced allergic rhinitis. Funding: Schering-Plough Romania
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Efficacy and Safety of Desloratadine in Combination with Mometasone Furoate in Patients With Moderate-to-Severe SAR G. Grevers1, B. Karmann2; 1Nose and Sinus Center, Starnberg, GERMANY, 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 moderate-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 (optional) 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 disturbances 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 adverse 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
J ALLERGY CLIN IMMUNOL JANUARY 2007
251
Mometasone Furoate Nasal Spray Rapidly and Enduringly Relieves Nasal Congestion and Other Symptoms of Seasonal Allergic Rhinitis G. N. Gross1, M. R. Danzig2, D. Gates2; 1Dallas Allergy and Asthma Center, Dallas, TX, 2Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: As one of the most bothersome symptoms of seasonal allergic rhinitis (SAR), congestion frequently interferes with sleep, daytime productivity/alertness, and quality of life. METHODS: This retrospective analysis of the onset and duration of efficacy 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
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Desloratadine Treatment Improves Symptoms in Patients With Seasonal Allergic Rhinitis I. Braverman1, M. Beiser2, Z. Gilad3; 1Hillel Yaffe Medical Center, Hadera, ISRAEL, 2The 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 itching, 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, practical problems, nasal and ocular symptoms, and other systems (eg, thirst). RESULTS: At the end of desloratadine treatment, the percentage of patients 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 reduction in all MiniRQLQ scores (P<0.0001 in all categories). The greatest improvements 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, constipation, urgency, or headache. CONCLUSIONS: Desloratadine was safe and effective in relieving SAR symptoms and improving patient QoL. Funding: Schering-Plough
SATURDAY
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
249
Improved Symptom Relief and Quality of Life With Desloratadine 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 polleninduced allergic rhinitis were treated with desloratadine 5 mg/day for 14 days. Three visits were scheduled: one within 30 days before patients entered 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 individual 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 symptoms and improving QoL in patients with pollen-induced allergic rhinitis. Funding: Schering-Plough Romania
250
Efficacy and Safety of Desloratadine in Combination with Mometasone Furoate in Patients With Moderate-to-Severe SAR G. Grevers1, B. Karmann2; 1Nose and Sinus Center, Starnberg, GERMANY, 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 moderate-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 (optional) 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 disturbances 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 adverse 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
J ALLERGY CLIN IMMUNOL JANUARY 2007
251
Mometasone Furoate Nasal Spray Rapidly and Enduringly Relieves Nasal Congestion and Other Symptoms of Seasonal Allergic Rhinitis G. N. Gross1, M. R. Danzig2, D. Gates2; 1Dallas Allergy and Asthma Center, Dallas, TX, 2Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: As one of the most bothersome symptoms of seasonal allergic rhinitis (SAR), congestion frequently interferes with sleep, daytime productivity/alertness, and quality of life. METHODS: This retrospective analysis of the onset and duration of efficacy 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 Patients With Seasonal Allergic Rhinitis I. Braverman1, M. Beiser2, Z. Gilad3; 1Hillel Yaffe Medical Center, Hadera, ISRAEL, 2The 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 itching, 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, practical problems, nasal and ocular symptoms, and other systems (eg, thirst). RESULTS: At the end of desloratadine treatment, the percentage of patients 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 reduction in all MiniRQLQ scores (P<0.0001 in all categories). The greatest improvements 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, constipation, urgency, or headache. CONCLUSIONS: Desloratadine was safe and effective in relieving SAR symptoms and improving patient QoL. Funding: Schering-Plough