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1002 Comparison of once-daily triamcinolone acetonide aqueous nasal spray and twice-daily beconase AQ® for the treatment of seasonal allergic rhinitis due to ragweed
J ALLERGYCLIN IMMUNOL VOLUME97, NUMBER1, PART3 1001
Patient satisfaction with seasonal allergic rhinitis t h e r a p y in a clinical trial comparing flntieasone with Ioratadine. E Schenkel MD. F Cox PhD. B Goodwin,
Abstracts
1003
Triamcinolone acetonide nasal spray (T) vs fluticasone pro. pionats aqueous nasal spray (F) in patients with seasonal allergic rhinitia. P Small MD, PA Houle MD, J Day MD, M Briscoe MD, M Gold MD, AJ Ham Pong ME), MAJ Mandl ME) M Sc,_l Brodarec MD Ph D, J Spenard Ph D, R Phillips Ph D, Montrdal Qc, Cap-de-la-Madeleine Qc, Kingston Ont, Brampton Ont, Ottawa Ont, Vancouver BC, Yarmouth NS. This study compared the efficacy of 2 different nasal steroids already shown effective in treating seasonal rhinitis T and F. Patients with positive skin test for local spring allergens, aged 12 to 70 years, and with history of rhinitis for z 2 years received T (n=113) 110 ~g or F (n=112) 100 ~g in each nostril QD, in an investigator-blind, parallel groups, 21-day study. They were included after cumulating a rhinitis index (RI), for at least 2 symptoms among nasal congestion, rhinorrhea, sneezing, and itching, ~24 over 4 days out of 5. They then recorded daily their RI. Mean (SEM) daily RI at baseline were 7.66 (.14) and 7.69 (.14) (p=.95) for T and F respectively. Mean (SEM) daily reductions from baseline in RI were compared by ANOVA: T F p Days 1 to 7 3.22 (.21) 3.52 (.21) 0.58 Days 8 to 14 4.38 (.23) 4.92 (.22) 0.11 Days 15 to 21 4.98 (.26) 5.39 (.25) 0.24 Days 1 to21 4.20(.21) 4.60(.21) 0.23 No significant difference was found among individual symptoms either. We therefore conclude that, since there is no statistically significant difference, T and F are clinically equivalent in reducing RI or individual symptoms in seasonal allergic rhinitis.
1004
Once Daily Mometasone Furoate Aqueous Nasal Spray in Seasonal Allergic Rhinitis: an Active and PlaceboControlled S t u d y . J HeberLbiD. KB Nolop MD. BN Lutskv. Ph.D.
.F._PiceneMD, D Aar0nson MD, K R¢~I, C Cook, P Rogenes PhD. (3 Ansehuetz, Eaton, PA & Research Triangle Park, NC A double-blind, randomized, 28-day study was conducted to compare fluticasone propionate nasal spray (FP) 200meg daily with encapsulated loratadine (LOR) 10rag daily in the treatment of seasonal allergic rhinitis. At baseline (Day 0) and at Days 14 and 28, a 7-item questionnaire was administered to 333 patients to assess patient satisfaction with their rhinitis medication. Responses were compared across treatment groups, adjusting for baseline scores, At baseline (Day 0), of the 7 items only satisfaction with sneezing relief (p=0.032) was significantly different between groups. There was a significant difference in overall satisfaction at baseline between the placebo and FP groups (p~0.006). At Day 28, patients who received FP rated their satisfaction with medication significantly higher (p<0.05) than did patients in the placebo group; and significantly higher for all nasal related items than the LOR and placebo groups. For eye related items there was significantly higher satisfaction both the FP and Ioratadine groups versus placebo; however, there was no difference between the FP and loratidine groups. At Day 28 the overall score (P<0.05) was significantly higher in the fluticasone group than in the loratadine or placebo groups. Overall patient satisfaction with medication was highest in the fluticasone group at Days 14 and 28. Overall patient satisfaction was correlated with the clinician overall evaluation of response to therapy, based upon patient symptoms (corr=0.702, p=0.0001). In summary, after 28 days of therapy, patients with seasonal allergic rhinitis who received FP had significantly higher satisfaction with their medication which correlated with rated efficacy.
1002
Comparison of O n c e - D a i l y T r i a m c i n o l o n e A c e t o n i d e Aqueous Nasal S p r a y a n d T w i c e - D a i l y B e c o n a s e A Q ® for t h e T r e a t m e n t o f S e a s o n a l Allergic Rhinitis Due to R a g w e e d , c LaForce MD, F Hampel MD, F Kieehel MD, W Lumry MD, JJ Murray MD, JA Furst BS. B Simuson BS, JA Smith MD, Raleigh, NC, New Branunfels, TX, Lincoln, NE, Dallas, TX, Nashville, TN, Collegeville, PA Triamcinolone acetonide (TAA) Aqueous nasal spray has previously been shown to improve seasonal allergic rhinitis (SAP,) symptoms due to ragweed (Settipane et al. Clin Ther 1995;17:252-263). This 3-week, randomized, double-blind trial compared the efficacy, safety, patient comfort ratings, and effect on patient quality of life of once-daily TAA Aqueous nasal spray (220 #g/day) and twice-daily Bcconase AQ ® (336 #g/day) in patients with SAR due to ragweed. SAR symptoms (nasal stuffiness, discharge, sneezing, itching, nasal index, eye symptoms), and patient comfort ratings were recorded daily; quality of life questionnaires were completed pretreatment and after each of the 3 weeks of treatment. TAA Aqueous nasal spray was comparable to Becenase AQ~ for all rhinitis symptoms, except for sneezing (P < 0.05). However, patients rated TAA Aqueous nasal spray as having significantly (P<0.05) better taste and smell than Beconase AQ ® after weeks 2 and 3, and overall for the 3 weeks of dosing. All safety, patient comfort, and quality-of-life scores were statistically similar for the 3week treatment period. This randomized, double-blind, trial demonstrated that once-daily administration of 220/,g TAA Aqueous nasal spray was comparable to Beconase AQ® given twice daily for the relief of SAR symptoms due to ragweed. Importantly, patients rated once-daily TAA Aqueous nasal spray as having significantly better taste and smell than twice-daily Becenase AQ®.
433
and the 192-200 Study Grouo. Quebec, Quebec, Canada and Kenilworth, NJ In this randomized, muRi-eenter, placebo-controlled study, patients with moderate or severe rhinitis symptoms due to tree or grass pollen were randomized to one of the following four regimens for four weeks: mometasonefuroate nasal spray (MFNS) 100 meg once daily, MFNS 200 meg once daily, beclomethasone dipropionate (BDP) 200 meg twice daily, or placebo vehicle control. Patients were assessed at screening, baseline (day 1), and days 4, 8, 15, 22, and 29. Patients also kept diaries on which thee recorded their symptoms twice daily. A total of 501 patients was enrolled, and 477 were evaluable for efficacy. For the primary efficacy variable of physician-rated total nasal symptoms (sum of sneezing, itching, stuffiness and discharge), all three active treatments were significantly superior to placebo at all timepoints (p<.01), except for the lower dose of MFNS at day 4. Overall, the effects of MFNS and BDP were similar, except that MFN8 200 meg was superior to BDP at day 15 (p=.05). Patient-rated total nasal symptom scores from the diaries were consistent with the physician ratings. Physician-rated total symptom scores and global evaluation of overall condition by physicians and patients, showed that the three active treatments were significantly superior to placebo at most time points. MFNS and BDP were equally well tolerated. In summmy,MFNS, which offers the convenience of once daily dosing, appears to be an active and well-tolerated alternative to twice-daily BDP for the treatment of moderate to severe seasonal allergic rhinitis.
Patient satisfaction with seasonal allergic rhinitis t h e r a p y in a clinical trial comparing flntieasone with Ioratadine. E Schenkel MD. F Cox PhD. B Goodwin,
Abstracts
1003
Triamcinolone acetonide nasal spray (T) vs fluticasone pro. pionats aqueous nasal spray (F) in patients with seasonal allergic rhinitia. P Small MD, PA Houle MD, J Day MD, M Briscoe MD, M Gold MD, AJ Ham Pong ME), MAJ Mandl ME) M Sc,_l Brodarec MD Ph D, J Spenard Ph D, R Phillips Ph D, Montrdal Qc, Cap-de-la-Madeleine Qc, Kingston Ont, Brampton Ont, Ottawa Ont, Vancouver BC, Yarmouth NS. This study compared the efficacy of 2 different nasal steroids already shown effective in treating seasonal rhinitis T and F. Patients with positive skin test for local spring allergens, aged 12 to 70 years, and with history of rhinitis for z 2 years received T (n=113) 110 ~g or F (n=112) 100 ~g in each nostril QD, in an investigator-blind, parallel groups, 21-day study. They were included after cumulating a rhinitis index (RI), for at least 2 symptoms among nasal congestion, rhinorrhea, sneezing, and itching, ~24 over 4 days out of 5. They then recorded daily their RI. Mean (SEM) daily RI at baseline were 7.66 (.14) and 7.69 (.14) (p=.95) for T and F respectively. Mean (SEM) daily reductions from baseline in RI were compared by ANOVA: T F p Days 1 to 7 3.22 (.21) 3.52 (.21) 0.58 Days 8 to 14 4.38 (.23) 4.92 (.22) 0.11 Days 15 to 21 4.98 (.26) 5.39 (.25) 0.24 Days 1 to21 4.20(.21) 4.60(.21) 0.23 No significant difference was found among individual symptoms either. We therefore conclude that, since there is no statistically significant difference, T and F are clinically equivalent in reducing RI or individual symptoms in seasonal allergic rhinitis.
1004
Once Daily Mometasone Furoate Aqueous Nasal Spray in Seasonal Allergic Rhinitis: an Active and PlaceboControlled S t u d y . J HeberLbiD. KB Nolop MD. BN Lutskv. Ph.D.
.F._PiceneMD, D Aar0nson MD, K R¢~I, C Cook, P Rogenes PhD. (3 Ansehuetz, Eaton, PA & Research Triangle Park, NC A double-blind, randomized, 28-day study was conducted to compare fluticasone propionate nasal spray (FP) 200meg daily with encapsulated loratadine (LOR) 10rag daily in the treatment of seasonal allergic rhinitis. At baseline (Day 0) and at Days 14 and 28, a 7-item questionnaire was administered to 333 patients to assess patient satisfaction with their rhinitis medication. Responses were compared across treatment groups, adjusting for baseline scores, At baseline (Day 0), of the 7 items only satisfaction with sneezing relief (p=0.032) was significantly different between groups. There was a significant difference in overall satisfaction at baseline between the placebo and FP groups (p~0.006). At Day 28, patients who received FP rated their satisfaction with medication significantly higher (p<0.05) than did patients in the placebo group; and significantly higher for all nasal related items than the LOR and placebo groups. For eye related items there was significantly higher satisfaction both the FP and Ioratadine groups versus placebo; however, there was no difference between the FP and loratidine groups. At Day 28 the overall score (P<0.05) was significantly higher in the fluticasone group than in the loratadine or placebo groups. Overall patient satisfaction with medication was highest in the fluticasone group at Days 14 and 28. Overall patient satisfaction was correlated with the clinician overall evaluation of response to therapy, based upon patient symptoms (corr=0.702, p=0.0001). In summary, after 28 days of therapy, patients with seasonal allergic rhinitis who received FP had significantly higher satisfaction with their medication which correlated with rated efficacy.
1002
Comparison of O n c e - D a i l y T r i a m c i n o l o n e A c e t o n i d e Aqueous Nasal S p r a y a n d T w i c e - D a i l y B e c o n a s e A Q ® for t h e T r e a t m e n t o f S e a s o n a l Allergic Rhinitis Due to R a g w e e d , c LaForce MD, F Hampel MD, F Kieehel MD, W Lumry MD, JJ Murray MD, JA Furst BS. B Simuson BS, JA Smith MD, Raleigh, NC, New Branunfels, TX, Lincoln, NE, Dallas, TX, Nashville, TN, Collegeville, PA Triamcinolone acetonide (TAA) Aqueous nasal spray has previously been shown to improve seasonal allergic rhinitis (SAP,) symptoms due to ragweed (Settipane et al. Clin Ther 1995;17:252-263). This 3-week, randomized, double-blind trial compared the efficacy, safety, patient comfort ratings, and effect on patient quality of life of once-daily TAA Aqueous nasal spray (220 #g/day) and twice-daily Bcconase AQ ® (336 #g/day) in patients with SAR due to ragweed. SAR symptoms (nasal stuffiness, discharge, sneezing, itching, nasal index, eye symptoms), and patient comfort ratings were recorded daily; quality of life questionnaires were completed pretreatment and after each of the 3 weeks of treatment. TAA Aqueous nasal spray was comparable to Becenase AQ~ for all rhinitis symptoms, except for sneezing (P < 0.05). However, patients rated TAA Aqueous nasal spray as having significantly (P<0.05) better taste and smell than Beconase AQ ® after weeks 2 and 3, and overall for the 3 weeks of dosing. All safety, patient comfort, and quality-of-life scores were statistically similar for the 3week treatment period. This randomized, double-blind, trial demonstrated that once-daily administration of 220/,g TAA Aqueous nasal spray was comparable to Beconase AQ® given twice daily for the relief of SAR symptoms due to ragweed. Importantly, patients rated once-daily TAA Aqueous nasal spray as having significantly better taste and smell than twice-daily Becenase AQ®.
433
and the 192-200 Study Grouo. Quebec, Quebec, Canada and Kenilworth, NJ In this randomized, muRi-eenter, placebo-controlled study, patients with moderate or severe rhinitis symptoms due to tree or grass pollen were randomized to one of the following four regimens for four weeks: mometasonefuroate nasal spray (MFNS) 100 meg once daily, MFNS 200 meg once daily, beclomethasone dipropionate (BDP) 200 meg twice daily, or placebo vehicle control. Patients were assessed at screening, baseline (day 1), and days 4, 8, 15, 22, and 29. Patients also kept diaries on which thee recorded their symptoms twice daily. A total of 501 patients was enrolled, and 477 were evaluable for efficacy. For the primary efficacy variable of physician-rated total nasal symptoms (sum of sneezing, itching, stuffiness and discharge), all three active treatments were significantly superior to placebo at all timepoints (p<.01), except for the lower dose of MFNS at day 4. Overall, the effects of MFNS and BDP were similar, except that MFN8 200 meg was superior to BDP at day 15 (p=.05). Patient-rated total nasal symptom scores from the diaries were consistent with the physician ratings. Physician-rated total symptom scores and global evaluation of overall condition by physicians and patients, showed that the three active treatments were significantly superior to placebo at most time points. MFNS and BDP were equally well tolerated. In summmy,MFNS, which offers the convenience of once daily dosing, appears to be an active and well-tolerated alternative to twice-daily BDP for the treatment of moderate to severe seasonal allergic rhinitis.