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Efficacy of Azelastine 0.15% Nasal Spray in Treating Nasal Symptoms of Perennial Allergic Rhinitis
AB176 Abstracts
688
The Addition of Montelukast to Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis R. Esteitie, M. deTineo, R. Naclerio, F. Baroody; University of Chicago, Chicago, IL. RATIONALE: Many patients with perennial allergic rhinitis (PAR) are prescribed 2 drugs to control their symptoms. We evaluated the effectiveness of montelukast as add-on therapy in subjects with PAR who have incomplete relief of symptoms after treatment with intranasal fluticasone propionate (FP). METHODS: We conducted a 4 week parallel, randomized, double-blind, placebo controlled, trial. A total of 102 patients with a history of PAR with a positive skin test to dust mite, cockroach, indoor mold(s), dog or cat were recruited. The subjects completed a Rhinitis Quality of Life Questionnaire (RQLQ) and were started on intranasal FP 200 mcg daily. They were asked to fill symptom diary cards twice daily. At the end of 2 weeks of treatment, subjects with a mean total nasal symptom score of >4 over the past week (n554) were randomized to receive either montelukast (n528) or placebo (n526) in addition to the continued use of FP. At weeks 3 and 4, a RQLQ was completed and symptom diary cards were collected and analyzed. RESULTS: Compared to baseline, there were significant improvements in almost all domains of the RQLQ while on FP (p<0.001). A similar trend was observed for nasal symptom scores. After randomization to montelukast and placebo, there were significant improvements in RQLQ measures and nasal symptom scores in both groups, with no significant differences between the groups during the 2 weeks of add-on therapy. CONCLUSIONS: The addition of montelukast to FP for the treatment of subjects with PAR with residual symptoms is no more effective than placebo.
689
MONDAY
Olopatadine 0.6% Nasal Spray Reduces Symptoms In Patients with Severe Vasomotor Rhinitis And Protects From Hyperosmolar Challenge P. K. Smith; Griffith University, Southport, AUSTRALIA. RATIONALE: The aim of this study was to identify the efficacy of Olopatadine 0.6% nasal spray in symptom reduction and airway function in patients with severe vasomotor rhinitis at baseline and with a hyperosmolar challenge. Hypersomolar challenge is well characterised to gate cation channels via the capsaicin receptor. METHODS:22 patients with severe rhinitis with predominant vasomotor triggers were consented and enrolled in DBPC cross over study. Patients were given either saline or 0.6% Olopatadine nasally. Hyperosmolar challenge involved 130ul of 400 mOsm mannitol solution each nostril. Instantaneous total nasal symptom score (iTNSS) and peak inspiratory nasal flow rates (PINFR) were recorded. RESULTS: In a paired 2 tail analysis, compared to baseline, patients treated with Olopatadine hydrochloride had a lower iTNSS at 5 and 30 minutes (-1.54 +/- 2.09 and -1.91 +/- 2.33) P50.054*NS and P<0.01. Olopatadine pre-treated patients had lower iTNSS at 30 minutes after mannitol challenge, which was not observed in the saline pre-treated patients (-0.95 +/- 2.40 vs +1.27 +/- 2.55) P<0.01 and higher PNIFR measurements (110 +/- 38.7 vs 81.8 +/- 26.7) P < 0.01. CONCLUSIONS: In patients with severe vasomotor rhinitis, Olopatadine 0.6% nasal spray improved nasal symptom scores at baseline and with mannitol challenge. The capsaicin channel blocking effect has been reported to be separate to the antihistamine effect of Olopatadine. This study strengthens the importance of the nociceptor TRPV1 in the pathophysiology of vasomotor rhinitis.
J ALLERGY CLIN IMMUNOL FEBRUARY 2010
690
Efficacy of Azelastine 0.15% Nasal Spray in Treating Nasal Symptoms of Perennial Allergic Rhinitis J. Bernstein1, J. Jacobs2, W. Wheeler3, H. Sacks3; 1Bernstein Clinical Research Center, Cincinnati, OH, 2Allergy and Asthma Clinical Research, Inc., Walnut Creek, CA, 3Meda Pharmaceuticals, Somerset, NJ. RATIONALE: The objective of this study was to evaluate the efficacy of a reformulated azelastine nasal spray (Astepro 0.15% nasal spray) at a dosage of 2 sprays per nostril twice daily in patients with perennial allergic rhinitis (PAR). METHODS: The study was a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe PAR conducted during the 2006/2007 winter season. A total of 581 patients were randomized to treatment with azelastine 0.15% 2 sprays per nostril twice daily (AM and PM), azelastine 0.10%, or placebo nasal spray. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. A key secondary efficacy variable was the change from baseline in the 12-hour reflective secondary symptom complex score (SSCS), consisting of postnasal drip, itchy eyes, cough, and headache. Symptoms were scored twice daily on a 4-point scale such that the maximum daily symptom score was 24. RESULTS: After 4 weeks of treatment, the mean TNSS improvement was statistically significant (P 5 .03) with azelastine nasal spray 0.15% (4.10; 25.7%) compared to placebo (3.33; 20.7%). The 0.10% formulation was not significant versus placebo. The mean SSCS also was significantly (P 5 .002) improved with azelastine nasal spray 0.15% (23.1%) compared to placebo (13.7%). Nasal discomfort (6.8%) and bitter taste (4.7%) were the most commonly reported adverse events with the 0.15% azelastine formulation. CONCLUSIONS: Azelastine 0.15% nasal spray was effective in treating nasal symptoms associated with PAR and was well tolerated.
691
Azelastine Nasal Spray (0.15%) Once Daily in Treating Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis F. Hampel1, P. Ratner2, W. Wheeler3, H. Sacks3; 1Central Texas Health Research, New Braunfels, TX, 2Sylvana Research Associates, San Antonio, TX, 3Meda Pharmaceuticals, Somerset, NJ. RATIONALE: The objective of this study was to evaluate the efficacy of a reformulated azelastine nasal spray (Astepro nasal spray 0.15%) at a dosage of 2 sprays per nostril once daily in treating nasal and ocular symptoms of seasonal allergic rhinitis (SAR). METHODS: The study was a double-blind, placebo-controlled trial conducted during the 2008/2009 Texas Mountain Cedar season. A total of 506 patients were randomized to treatment with azelastine 0.15% at a dosage of 2 sprays per nostril once daily (AM) or placebo spray. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. A key secondary efficacy variable was the change from baseline in the 12-hour reflective total ocular symptom score (TOSS), consisting of itchy eyes, watery eyes, and red eyes. TNSS and TOSS symptoms were scored twice daily on a 4-point scale. RESULTS: After 2 weeks of treatment, the mean TNSS improvement score and percentage TNSS improvement score were statistically significant (P<.001) with azelastine nasal spray 0.15% (3.57; 19.3%) compared to placebo (2.14; 11.4%). The overall TOSS improvement score and percentage TOSS improvement score were also statistically significant (P.01) with azelastine 0.15% nasal spray (2.21; 16.7%) compared to placebo (1.28; 6.0%). Nasal discomfort (3.6%) and bitter taste (2.4%) were the most commonly reported adverse events with the 0.15% azelastine formulation. CONCLUSIONS: Azelastine nasal spray 0.15% was effective in treating nasal and ocular symptoms of SAR with a low incidence of adverse events.
688
The Addition of Montelukast to Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis R. Esteitie, M. deTineo, R. Naclerio, F. Baroody; University of Chicago, Chicago, IL. RATIONALE: Many patients with perennial allergic rhinitis (PAR) are prescribed 2 drugs to control their symptoms. We evaluated the effectiveness of montelukast as add-on therapy in subjects with PAR who have incomplete relief of symptoms after treatment with intranasal fluticasone propionate (FP). METHODS: We conducted a 4 week parallel, randomized, double-blind, placebo controlled, trial. A total of 102 patients with a history of PAR with a positive skin test to dust mite, cockroach, indoor mold(s), dog or cat were recruited. The subjects completed a Rhinitis Quality of Life Questionnaire (RQLQ) and were started on intranasal FP 200 mcg daily. They were asked to fill symptom diary cards twice daily. At the end of 2 weeks of treatment, subjects with a mean total nasal symptom score of >4 over the past week (n554) were randomized to receive either montelukast (n528) or placebo (n526) in addition to the continued use of FP. At weeks 3 and 4, a RQLQ was completed and symptom diary cards were collected and analyzed. RESULTS: Compared to baseline, there were significant improvements in almost all domains of the RQLQ while on FP (p<0.001). A similar trend was observed for nasal symptom scores. After randomization to montelukast and placebo, there were significant improvements in RQLQ measures and nasal symptom scores in both groups, with no significant differences between the groups during the 2 weeks of add-on therapy. CONCLUSIONS: The addition of montelukast to FP for the treatment of subjects with PAR with residual symptoms is no more effective than placebo.
689
MONDAY
Olopatadine 0.6% Nasal Spray Reduces Symptoms In Patients with Severe Vasomotor Rhinitis And Protects From Hyperosmolar Challenge P. K. Smith; Griffith University, Southport, AUSTRALIA. RATIONALE: The aim of this study was to identify the efficacy of Olopatadine 0.6% nasal spray in symptom reduction and airway function in patients with severe vasomotor rhinitis at baseline and with a hyperosmolar challenge. Hypersomolar challenge is well characterised to gate cation channels via the capsaicin receptor. METHODS:22 patients with severe rhinitis with predominant vasomotor triggers were consented and enrolled in DBPC cross over study. Patients were given either saline or 0.6% Olopatadine nasally. Hyperosmolar challenge involved 130ul of 400 mOsm mannitol solution each nostril. Instantaneous total nasal symptom score (iTNSS) and peak inspiratory nasal flow rates (PINFR) were recorded. RESULTS: In a paired 2 tail analysis, compared to baseline, patients treated with Olopatadine hydrochloride had a lower iTNSS at 5 and 30 minutes (-1.54 +/- 2.09 and -1.91 +/- 2.33) P50.054*NS and P<0.01. Olopatadine pre-treated patients had lower iTNSS at 30 minutes after mannitol challenge, which was not observed in the saline pre-treated patients (-0.95 +/- 2.40 vs +1.27 +/- 2.55) P<0.01 and higher PNIFR measurements (110 +/- 38.7 vs 81.8 +/- 26.7) P < 0.01. CONCLUSIONS: In patients with severe vasomotor rhinitis, Olopatadine 0.6% nasal spray improved nasal symptom scores at baseline and with mannitol challenge. The capsaicin channel blocking effect has been reported to be separate to the antihistamine effect of Olopatadine. This study strengthens the importance of the nociceptor TRPV1 in the pathophysiology of vasomotor rhinitis.
J ALLERGY CLIN IMMUNOL FEBRUARY 2010
690
Efficacy of Azelastine 0.15% Nasal Spray in Treating Nasal Symptoms of Perennial Allergic Rhinitis J. Bernstein1, J. Jacobs2, W. Wheeler3, H. Sacks3; 1Bernstein Clinical Research Center, Cincinnati, OH, 2Allergy and Asthma Clinical Research, Inc., Walnut Creek, CA, 3Meda Pharmaceuticals, Somerset, NJ. RATIONALE: The objective of this study was to evaluate the efficacy of a reformulated azelastine nasal spray (Astepro 0.15% nasal spray) at a dosage of 2 sprays per nostril twice daily in patients with perennial allergic rhinitis (PAR). METHODS: The study was a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe PAR conducted during the 2006/2007 winter season. A total of 581 patients were randomized to treatment with azelastine 0.15% 2 sprays per nostril twice daily (AM and PM), azelastine 0.10%, or placebo nasal spray. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. A key secondary efficacy variable was the change from baseline in the 12-hour reflective secondary symptom complex score (SSCS), consisting of postnasal drip, itchy eyes, cough, and headache. Symptoms were scored twice daily on a 4-point scale such that the maximum daily symptom score was 24. RESULTS: After 4 weeks of treatment, the mean TNSS improvement was statistically significant (P 5 .03) with azelastine nasal spray 0.15% (4.10; 25.7%) compared to placebo (3.33; 20.7%). The 0.10% formulation was not significant versus placebo. The mean SSCS also was significantly (P 5 .002) improved with azelastine nasal spray 0.15% (23.1%) compared to placebo (13.7%). Nasal discomfort (6.8%) and bitter taste (4.7%) were the most commonly reported adverse events with the 0.15% azelastine formulation. CONCLUSIONS: Azelastine 0.15% nasal spray was effective in treating nasal symptoms associated with PAR and was well tolerated.
691
Azelastine Nasal Spray (0.15%) Once Daily in Treating Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis F. Hampel1, P. Ratner2, W. Wheeler3, H. Sacks3; 1Central Texas Health Research, New Braunfels, TX, 2Sylvana Research Associates, San Antonio, TX, 3Meda Pharmaceuticals, Somerset, NJ. RATIONALE: The objective of this study was to evaluate the efficacy of a reformulated azelastine nasal spray (Astepro nasal spray 0.15%) at a dosage of 2 sprays per nostril once daily in treating nasal and ocular symptoms of seasonal allergic rhinitis (SAR). METHODS: The study was a double-blind, placebo-controlled trial conducted during the 2008/2009 Texas Mountain Cedar season. A total of 506 patients were randomized to treatment with azelastine 0.15% at a dosage of 2 sprays per nostril once daily (AM) or placebo spray. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. A key secondary efficacy variable was the change from baseline in the 12-hour reflective total ocular symptom score (TOSS), consisting of itchy eyes, watery eyes, and red eyes. TNSS and TOSS symptoms were scored twice daily on a 4-point scale. RESULTS: After 2 weeks of treatment, the mean TNSS improvement score and percentage TNSS improvement score were statistically significant (P<.001) with azelastine nasal spray 0.15% (3.57; 19.3%) compared to placebo (2.14; 11.4%). The overall TOSS improvement score and percentage TOSS improvement score were also statistically significant (P.01) with azelastine 0.15% nasal spray (2.21; 16.7%) compared to placebo (1.28; 6.0%). Nasal discomfort (3.6%) and bitter taste (2.4%) were the most commonly reported adverse events with the 0.15% azelastine formulation. CONCLUSIONS: Azelastine nasal spray 0.15% was effective in treating nasal and ocular symptoms of SAR with a low incidence of adverse events.