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Efficacy of astelin nasal spray in patients with an unsatisfactory response to claritin
Otolaryngology– Head and Neck Surgery Volume 129 Number 2
R067 Evaluation of Azelastine (Astelin) Nasal Spray in Allergic and Vasomotor Rhinitis Andrew J Lerrick MD (presenter) Chicago IL
Problem: The objective of this open-label protocol was to evaluate patients with seasonal allergic rhinitis or non-allergic vasomotor rhinitis who were treated with azelastine (Astelin) nasal spray at a dosage of 2 sprays per nostril twice daily for 2 weeks. Methods: Participating physicians enrolled up to 10 patients in the program. An initial survey for each patient included demographics, rhinitis history, and previous medication use. After 2 weeks of treatment with azelastine, patients completed a form that assessed its onset of action, sleep quality, quality of life, symptom improvement, and satisfaction with therapy. Results: 2062 patients at 528 sites completed the evaluation. ENT specialists comprised 9% of the participating physicians. 31% of the 2062 patients had seasonal allergic rhinitis, 53% had seasonal allergic rhinitis with non-allergic triggers, 13% had non-allergic vasomotor rhinitis, and 3%
had no recorded diagnosis. The mean age was 51 years and 61% of the patients were female. Azelastine monotherapy was prescribed in 86% of patients. Onset of action occurred within 1 hour in 88%. Sleep quality improved in 81%. 64% reported improvement with azelastine when compared to their previous rhinitis medication, which included oral antihistamines and nasal steroids. Symptom control (somewhat or completely) was ⬎80% for rhinitis symptoms, in particular, nasal congestion (86%), sneezing (89%), rhinorrhea (85%), and nasal itching (88%). Conclusion: Azelastine demonstrated a rapid onset of action and was reportedly more effective than alternative rhinitis medication by a majority of patients. Significance: This study suggests that azelastine is an effective treatment alternative to oral antihistamines and nasal steroids. Support: Wallace Pharmaceuticals Division, MedPointe Healthcare, Inc
R068 Efficacy of Astelin Nasal Spray in Patients with an Unsatisfactory Response to Claritin Martha V White MD (presenter) Wheaton MD
Problem: The primary objective of this multicenter, double-blind, placebo-controlled study was to evaluate the effectiveness and safety of (1) Astelin (azelastine) nasal spray, (2) Clarinex (desloratadine), and (3) Astelin nasal spray plus Claritin in patients with seasonal allergic rhinitis who had an unsatisfactory (less than 25% to 33% improvement during run-in) response to treatment with Claritin. Methods: The primary efficacy variable was the change from baseline to day 14 in the Total Nasal Symptom Score (TNSS), consisting of runny nose, sneezing, itchy nose, and nasal congestion, when compared to placebo. At day 7, patients who qualified with a minimum TNSS score (8 of a possible 12) and met the study inclusion/exclusion criteria were given a 1-week supply of Claritin. One week later on day 1, patients who did not meet the symptom qualification criteria (greater than 33% improvement on Claritin) or other study entry criteria were discontinued. Patients who met the study entrance criteria and who satisfied the symptom severity criteria (N ⫽ 438) were randomized to one of the four treatment groups. Results: A total of 435 patients completed the 2-week double-blind treatment period. After 2 weeks of treatment, Astelin nasal spray (P ⫽ 0.0008), Astelin nasal spray plus Claritin (P ⫽ 0.0007), and Clarinex (P ⫽ 0.039) were statistically superior to placebo in treating patients with an unsatisfactory response to Claritin. Conclusion: Astelin nasal spray and Clarinex were both effective in treating patients with a poor response to Claritin;
POSTERS
Problem: This study aimed to examine whether mucosal administration of Dermatophagoides farinae (Der f) coupled to CTB would modulate Der f–specific type 1 hypersensitivity in a murine model of allergic rhinitis and to evaluate the prophylactic and long-term therapeutic effect. Methods: Allergic rhinitis was induced with systemic and local sensitization of house dust mite crude extract in C57BL/6 mice. In the prophylactic group, mice were treated with intranasal challenge of HDM-CTB conjugates once a week for 3 weeks prior to the systemic sensitization. In the therapeutic group, mice were treated after the sensitization. Allergic symptom score, HDM-specific IgE level, T-cell proliferation assay, and eosinophil infiltration into the nasal mucosa of the treatment group were compared with those of control group and naive group. Results: The allergic symptom score, HDM-specific IgE level, T-cell proliferation assay, and eosinophil infiltration into the nasal mucosa showed no significant differences between the prophylactic and positive control groups. In the therapeutic group, these parameters were significantly lower than in the control group at the first and second week. But after 4 weeks of administration, there was no significant difference between the two groups. Conclusion: We could see the immune-tolerant effect of HDM-CTB conjugate when administrated transorally in experimentally induced murine allergic rhinitis model, but this effect did not last beyond 4 weeks. Significance: This study demonstrates the possibility of treating allergic rhinitis with HDM-CTB conjugate. Support: None reported.
Research Posters P177
Research Posters
however, the combination of Astelin nasal spray with Claritin was not more effective than Astelin nasal spray alone. Significance: Astelin nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to Claritin and is an alternative to treatment with intranasal steroids for these patients. Support: Supported by a grant from Wallace Pharmaceuticals Division, MedPointe Healthcare Inc.
R069 The Role of Cytokines in Nasal Polyp Formation Mike S Shin MD (presenter); John R Houck Jr MD; Megan R Lerner BS; Daniel J Brackett MA; Elizabeth M Gillies MD Edmond OK; Oklahoma City OK; Oklahoma City OK; Oklahoma City OK; Oklahoma City OK
Problem: Cytokines have been shown to play a significant role in nasal polyp formation, but previous studies have been limited by the fact that only a few cytokines could be evaluated at any one study. With the current technology using the cDNA array, we can identify cytokine activation in chronic sinusitis and nasal polyps using 268 human cytokine and receptor genes, enabling us to look for larger patterns of gene expression than previously possible. We hypothesized that expression of certain groups of cytokines is responsible for formation of nasal polyps in patients with chronic sinusitis. The purpose of this study is to identify a group of cytokine and cytokine receptor genes that is responsible for transformation of chronic sinusitis state to nasal polyp formation. Methods: Nasal tissue was collected from patients diagnosed with chronic sinusitis and nasal polyps (n ⫽ 5). Turbinates from normal patients were collected as a control group. cDNA arrays of these three groups were run simultaneously. The cytokines that were found to have increased mRNA levels of 5-fold or more and an absolute difference in MDC (molecular dynamic count) levels of 150 between the chronic sinusitis and nasal polyp groups were further verified with RT-PCR and immunohistochemistry. Results: Several cytokines have emerged as potential candidates for RT-PCR. However, data are preliminary and more cDNA array runs are needed to confirm these data. Conclusion: It appears that there is a group of cytokines that may be responsible for transformation of chronic sinusitis state to nasal polyp. Significance: This study marks a further step toward a better understanding of the underlying mechanisms of nasal polyp formation. Knowledge of the cytokines involved will facilitate pharmacologic treatments targeted at cytokines to prevent nasal polyp recurrence. Support: This research project was supported by a 2002 Resident Research grant from the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
R070 Vascular Endothelial Growth Factor in Nasal Polyposis in Asthmatic and Non-Asthmatic Patients Neil D Bateman (presenter); Abi Shahi MD; Ken Feeley FRCP; Timothy Woolford FRCS Sheffield United Kingdom; Sheffield United Kingdom; Sheffield United Kingdom; Sheffield United Kingdom
Problem: Nasal polyposis is a common condition of unknown etiology. There is, however, a recognized clinical association between nasal polyposis and other conditions including asthma. Nasal polyps are characterized histologically by large quantities of extracellular fluid as well as an inflammatory cell infiltrate. Vascular endothelial growth factor (VEGF) is a potent mediator of angiogenesis and vascular permeability which is known to be expressed in nasal polyps and asthmatic airways. This study aimed to determine whether the expression of VEGF was different in polyps from patients with asthma compared to those with nasal polyposis with no associated disease. Methods: Local ethical committee approval was obtained for the study. Archived specimens were retrieved from patients who had undergone nasal polyp surgery and their case notes reviewed. The diagnosis of asthma was based on a documented physician diagnosis and appropriate drug treatment. The wax-embedded specimens were cut into 5-mm sections and stained using an avidin-biotin immunohistochemical technique using a polyclonal antibody to VEGF. The degree of staining of the vascular endothelium was quantified using a grading system (0-3, no staining-strong staining). Results: 16 asthmatic and 20 non-asthmatic patients were studied. VEGF expression was identified in vascular endothelial cells, epithelial cells, and inflammatory cells. The grading of the endothelial staining was greater in the asthmatic group (P ⬍ 0.05). Conclusion: The endothelial expression of VEGF in nasal polyposis was greater in asthmatic than non-asthmatic patients. Significance: The higher level of VEGF expression in asthmatic polyps may indicate a variation in the inflammatory process between asthmatic and idiopathic nasal polyposis. Support: This work was supported by a donation from the Fred and Ann Green Legacy, Doncaster, United Kingdom. R072 Appearance of Fas and Fas Ligand in Oral and Pharyngeal Intractable Recurrent Ulcers Katsuhide Inagi MD (presenter); Shunsuke Miyamoto MD; Keiko Hasumi RN Tokyo Japan; Saitama Japan; Kitamoto Saitama Japan
Problem: The etiology and clinical definition of intractable recurrent ulcer (IRU) of the oral cavity and pharynx are unknown. Intractable recurrent ulcer of the oral and pharynx
POSTERS
P178
Otolaryngology– Head and Neck Surgery August 2003
R067 Evaluation of Azelastine (Astelin) Nasal Spray in Allergic and Vasomotor Rhinitis Andrew J Lerrick MD (presenter) Chicago IL
Problem: The objective of this open-label protocol was to evaluate patients with seasonal allergic rhinitis or non-allergic vasomotor rhinitis who were treated with azelastine (Astelin) nasal spray at a dosage of 2 sprays per nostril twice daily for 2 weeks. Methods: Participating physicians enrolled up to 10 patients in the program. An initial survey for each patient included demographics, rhinitis history, and previous medication use. After 2 weeks of treatment with azelastine, patients completed a form that assessed its onset of action, sleep quality, quality of life, symptom improvement, and satisfaction with therapy. Results: 2062 patients at 528 sites completed the evaluation. ENT specialists comprised 9% of the participating physicians. 31% of the 2062 patients had seasonal allergic rhinitis, 53% had seasonal allergic rhinitis with non-allergic triggers, 13% had non-allergic vasomotor rhinitis, and 3%
had no recorded diagnosis. The mean age was 51 years and 61% of the patients were female. Azelastine monotherapy was prescribed in 86% of patients. Onset of action occurred within 1 hour in 88%. Sleep quality improved in 81%. 64% reported improvement with azelastine when compared to their previous rhinitis medication, which included oral antihistamines and nasal steroids. Symptom control (somewhat or completely) was ⬎80% for rhinitis symptoms, in particular, nasal congestion (86%), sneezing (89%), rhinorrhea (85%), and nasal itching (88%). Conclusion: Azelastine demonstrated a rapid onset of action and was reportedly more effective than alternative rhinitis medication by a majority of patients. Significance: This study suggests that azelastine is an effective treatment alternative to oral antihistamines and nasal steroids. Support: Wallace Pharmaceuticals Division, MedPointe Healthcare, Inc
R068 Efficacy of Astelin Nasal Spray in Patients with an Unsatisfactory Response to Claritin Martha V White MD (presenter) Wheaton MD
Problem: The primary objective of this multicenter, double-blind, placebo-controlled study was to evaluate the effectiveness and safety of (1) Astelin (azelastine) nasal spray, (2) Clarinex (desloratadine), and (3) Astelin nasal spray plus Claritin in patients with seasonal allergic rhinitis who had an unsatisfactory (less than 25% to 33% improvement during run-in) response to treatment with Claritin. Methods: The primary efficacy variable was the change from baseline to day 14 in the Total Nasal Symptom Score (TNSS), consisting of runny nose, sneezing, itchy nose, and nasal congestion, when compared to placebo. At day 7, patients who qualified with a minimum TNSS score (8 of a possible 12) and met the study inclusion/exclusion criteria were given a 1-week supply of Claritin. One week later on day 1, patients who did not meet the symptom qualification criteria (greater than 33% improvement on Claritin) or other study entry criteria were discontinued. Patients who met the study entrance criteria and who satisfied the symptom severity criteria (N ⫽ 438) were randomized to one of the four treatment groups. Results: A total of 435 patients completed the 2-week double-blind treatment period. After 2 weeks of treatment, Astelin nasal spray (P ⫽ 0.0008), Astelin nasal spray plus Claritin (P ⫽ 0.0007), and Clarinex (P ⫽ 0.039) were statistically superior to placebo in treating patients with an unsatisfactory response to Claritin. Conclusion: Astelin nasal spray and Clarinex were both effective in treating patients with a poor response to Claritin;
POSTERS
Problem: This study aimed to examine whether mucosal administration of Dermatophagoides farinae (Der f) coupled to CTB would modulate Der f–specific type 1 hypersensitivity in a murine model of allergic rhinitis and to evaluate the prophylactic and long-term therapeutic effect. Methods: Allergic rhinitis was induced with systemic and local sensitization of house dust mite crude extract in C57BL/6 mice. In the prophylactic group, mice were treated with intranasal challenge of HDM-CTB conjugates once a week for 3 weeks prior to the systemic sensitization. In the therapeutic group, mice were treated after the sensitization. Allergic symptom score, HDM-specific IgE level, T-cell proliferation assay, and eosinophil infiltration into the nasal mucosa of the treatment group were compared with those of control group and naive group. Results: The allergic symptom score, HDM-specific IgE level, T-cell proliferation assay, and eosinophil infiltration into the nasal mucosa showed no significant differences between the prophylactic and positive control groups. In the therapeutic group, these parameters were significantly lower than in the control group at the first and second week. But after 4 weeks of administration, there was no significant difference between the two groups. Conclusion: We could see the immune-tolerant effect of HDM-CTB conjugate when administrated transorally in experimentally induced murine allergic rhinitis model, but this effect did not last beyond 4 weeks. Significance: This study demonstrates the possibility of treating allergic rhinitis with HDM-CTB conjugate. Support: None reported.
Research Posters P177
Research Posters
however, the combination of Astelin nasal spray with Claritin was not more effective than Astelin nasal spray alone. Significance: Astelin nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to Claritin and is an alternative to treatment with intranasal steroids for these patients. Support: Supported by a grant from Wallace Pharmaceuticals Division, MedPointe Healthcare Inc.
R069 The Role of Cytokines in Nasal Polyp Formation Mike S Shin MD (presenter); John R Houck Jr MD; Megan R Lerner BS; Daniel J Brackett MA; Elizabeth M Gillies MD Edmond OK; Oklahoma City OK; Oklahoma City OK; Oklahoma City OK; Oklahoma City OK
Problem: Cytokines have been shown to play a significant role in nasal polyp formation, but previous studies have been limited by the fact that only a few cytokines could be evaluated at any one study. With the current technology using the cDNA array, we can identify cytokine activation in chronic sinusitis and nasal polyps using 268 human cytokine and receptor genes, enabling us to look for larger patterns of gene expression than previously possible. We hypothesized that expression of certain groups of cytokines is responsible for formation of nasal polyps in patients with chronic sinusitis. The purpose of this study is to identify a group of cytokine and cytokine receptor genes that is responsible for transformation of chronic sinusitis state to nasal polyp formation. Methods: Nasal tissue was collected from patients diagnosed with chronic sinusitis and nasal polyps (n ⫽ 5). Turbinates from normal patients were collected as a control group. cDNA arrays of these three groups were run simultaneously. The cytokines that were found to have increased mRNA levels of 5-fold or more and an absolute difference in MDC (molecular dynamic count) levels of 150 between the chronic sinusitis and nasal polyp groups were further verified with RT-PCR and immunohistochemistry. Results: Several cytokines have emerged as potential candidates for RT-PCR. However, data are preliminary and more cDNA array runs are needed to confirm these data. Conclusion: It appears that there is a group of cytokines that may be responsible for transformation of chronic sinusitis state to nasal polyp. Significance: This study marks a further step toward a better understanding of the underlying mechanisms of nasal polyp formation. Knowledge of the cytokines involved will facilitate pharmacologic treatments targeted at cytokines to prevent nasal polyp recurrence. Support: This research project was supported by a 2002 Resident Research grant from the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
R070 Vascular Endothelial Growth Factor in Nasal Polyposis in Asthmatic and Non-Asthmatic Patients Neil D Bateman (presenter); Abi Shahi MD; Ken Feeley FRCP; Timothy Woolford FRCS Sheffield United Kingdom; Sheffield United Kingdom; Sheffield United Kingdom; Sheffield United Kingdom
Problem: Nasal polyposis is a common condition of unknown etiology. There is, however, a recognized clinical association between nasal polyposis and other conditions including asthma. Nasal polyps are characterized histologically by large quantities of extracellular fluid as well as an inflammatory cell infiltrate. Vascular endothelial growth factor (VEGF) is a potent mediator of angiogenesis and vascular permeability which is known to be expressed in nasal polyps and asthmatic airways. This study aimed to determine whether the expression of VEGF was different in polyps from patients with asthma compared to those with nasal polyposis with no associated disease. Methods: Local ethical committee approval was obtained for the study. Archived specimens were retrieved from patients who had undergone nasal polyp surgery and their case notes reviewed. The diagnosis of asthma was based on a documented physician diagnosis and appropriate drug treatment. The wax-embedded specimens were cut into 5-mm sections and stained using an avidin-biotin immunohistochemical technique using a polyclonal antibody to VEGF. The degree of staining of the vascular endothelium was quantified using a grading system (0-3, no staining-strong staining). Results: 16 asthmatic and 20 non-asthmatic patients were studied. VEGF expression was identified in vascular endothelial cells, epithelial cells, and inflammatory cells. The grading of the endothelial staining was greater in the asthmatic group (P ⬍ 0.05). Conclusion: The endothelial expression of VEGF in nasal polyposis was greater in asthmatic than non-asthmatic patients. Significance: The higher level of VEGF expression in asthmatic polyps may indicate a variation in the inflammatory process between asthmatic and idiopathic nasal polyposis. Support: This work was supported by a donation from the Fred and Ann Green Legacy, Doncaster, United Kingdom. R072 Appearance of Fas and Fas Ligand in Oral and Pharyngeal Intractable Recurrent Ulcers Katsuhide Inagi MD (presenter); Shunsuke Miyamoto MD; Keiko Hasumi RN Tokyo Japan; Saitama Japan; Kitamoto Saitama Japan
Problem: The etiology and clinical definition of intractable recurrent ulcer (IRU) of the oral cavity and pharynx are unknown. Intractable recurrent ulcer of the oral and pharynx
POSTERS
P178
Otolaryngology– Head and Neck Surgery August 2003