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The burden of rhinitis in children with asthma
S128 Abstracts
Montelukast and Desloratadine in the Treatment of Chronic (Perennial) Allergic Rhinitis: A Randomised, Double Blind, Placebo Controlled Study. M. Ciebiada1, M. Gorska-Ciebiada1, L. DuBuske2, P. Gorski1; 1Dept.Pneumology & Allergy, Medical University Lodz, Lodz, POLAND, 2Immunology Research Institute of New England, Boston, NH. RATIONALE: Montelukast hasn’t been evaluated for perennial rhinitis yet. The aim of this study was to investigate effects of 6-weeks lasting treatment of perennial rhinitis with desloratadine, montelukast alone and in combination. METHODS: We performed 32 weeks lasting randomized, double blind, placebo controlled, cross over study in 20 adult patients with: ≥2 years history, hyperresponsiveness to mites, total nasal symptom score ≥6 (congestion ≥2). There were four 6-weeks lasting treatment periods separated by 2-week wash outs. In each treatment period patients received: montelukast 10 mg or desloratadine 5 mg per day, or combination of montelukast 10 mg and desloratadine 5 mg or placebo. The sequence of taking pills was assigned randomly. Symptom score, physical examination, skin prick tests, spirometry and nasal lavage were performed the day before and in the last day of each treatment period . In nasal lavage ECP and eosinophil count were investigated. RESULTS: Total nasal symptom score : before the treatment 9,7; after placebo 8,3; after desloratadine 5,1; after montelukast 4,56, montelukast +desloratadine 4,04 . Improvement of nasal symptom score in subjects treated with montelukast alone or desloratadine alone was significant. Improvement after the treatment with a combination of both agents compared to each of them was slightly greater. The level of ECP in nasal lavage decreased after the treatment with all of agents separately but it was the greater after the combined medication. CONCLUSIONS: The treatment of chronic rhinitis with a combination of montelukast and desloratadine is more effective than with each of them alone.
510
SUNDAY
511
The Burden of Rhinitis in Children With Asthma
E. Civelek, C. N. Kocabas, C. Sackesen, F. Orhan, A. Tuncer, G. Adalioglu, B. E. Sekerel; Schol of medicine, HACETTEPE UNIVERSITY, Ankara, TURKEY. RATIONALE: Although the clinical association of allergic rhinitis and asthma appears to be stronger than has been reported previously, data for children is less clear and results observed in developing countries seem to differ from those observed in western populations. We have therefore intended to document the association of rhinitis with pediatric asthma in terms of caregivers’ perception, physician practice and file records. METHODS: 369 asthmatic children aged 3 to 16 years with at least oneyear follow-up were questioned along a questionnaire and their file records were evaluated retrospectively. RESULTS: A greater proportion of the respondents were male(63.7%), atopics(78.3%) and mild asthmatics(50.7%). House dust mite(50.7%) and grass pollens(46.9%), were the most commonly sensitized allergens. Although 5.4% of our study population regarded themselves as rhinitic and 23.8% had been diagnosed as allergic rhinitis according to the file records, 68.8% had consistent findings for allergic rhinitis and 57.7% of patients had required medications for rhinitis within the last year. Furthermore, 41.2% and 58.8% reported that their rhinitis symptoms caused a significant burden in their daily life and exacerbated their asthma, respectively. CONCLUSIONS: Although with regard to rhinitis prevalence determined in the survey and medications used for rhinitis, results appeared to be in agreement, there were certain differences in terms of the low frequency of rhinitis diagnosis observed in file records and many patients’
J ALLERGY CLIN IMMUNOL FEBRUARY 2005
lack of information regarding allergic rhinitis, indicating the need for a greater effort to identify and label rhinitics in asthma outpatient-clinics and to educate patients regarding their disease. Patients’ Willingness to Pay for Intranasal Corticosteroid Therapy: The Importance of Sensory Attributes S. Shah1, P. J. Mahadevia2, C. Leibman3, L. Kleinman2, L. O’Dowd3; 1Allergy & Asthma Consultants of NJ-PA, Collegeville, PA, 2MEDTAP International, Bethesda, MD, 3AstraZeneca, Wilmington, DE. RATIONALE: We evaluated patients’ willingness to pay (WTP) for intranasal corticosteroid (INS) products with differing sensory attribute profiles. METHODS: A cross-sectional survey of 120 patients with allergic rhinitis was conducted in 4 US allergy/immunology clinics. Participants chose between hypothetical INSs differing in intensity across 6 attributes (smell, taste, aftertaste, throat rundown, nose runout, and feel of spray) and monthly co-pays ($15, $30, $50). Attributes were characterized by 3 levels (eg, strong, weak, and none). Strength of preference was measured as marginal WTP to avoid higher-intensity levels. RESULTS: Patients were willing to pay $11 (95% confidence interval [CI]: $9 to $13) per month to avoid strong smell over no smell, $12 (95% CI: $10 to $14) to avoid strong taste over no taste, $20 (95% CI: $18 to $22) to avoid strong aftertaste over no aftertaste, $10 (95% CI: $9 to $12) to avoid excess throat rundown over no throat rundown, $11 (95% CI: $9 to $13) to avoid excess nose runout over none, and $6 (95% CI: $4 to $8) per month to avoid dry spray over moist spray. Comparing moderate to low intensity levels, aftertaste, throat rundown, and nose runout were still associated with a significant WTP. Income level was not associated with changes in WTP except for throat rundown. Patients with an income >$80,000 were willing to pay more to avoid excess throat rundown than those with an income <$40,000. CONCLUSIONS: Patients value certain INS product attributes and are willing to pay for an INS with favorable sensory attributes. Funding: AstraZeneca
512
Equivalence of Pseudoephedrine and Montelukast in the Treatment of Seasonal Allergic Rhinitis (SAR) F. M. Baroody, S. Mucha, M. deTineo, R. M. Naclerio; OtolaryngologyHead and Neck Surgery, The University of Chicago, Chicago, IL. RATIONALE: Both montelukast and pseudoephedrine are used for the treatment of SAR. Pseudoephedrine (PSE), while effective in the relief of nasal congestion, has unwanted side effects. Montelukast is effective and has no significant side effects. METHODS: We conducted a randomized, IRB-approved, double-blind study comparing the efficacy of PSE and montelukast in patients with ragweed SAR. Subjects with positive skin test to ragweed and a history of symptoms were recruited. After recording baseline nasal symptoms, nasal peak inspiratory flow (NPIF), and diurnal and nocturnal Rhinoconjunctivitis Quality of Life (QOL) scores, subjects were randomized to receive either PSE 240 mg or montelukast 10 mg PO daily in the morning for 2 weeks. They recorded nasal symptoms, and NPIF twice daily and filled QOL questionnaires and 2 tolerability profiles at study end. RESULTS: Both treatments resulted in significant improvements from baseline in all symptoms of allergic rhinitis as well as in all QOL domains. When changes from baseline were compared between treatments, there were no significant differences except in the symptom of nasal congestion where pseudoephedrine had superior efficacy compared to montelukast. Both treatments resulted in a significant increase in NPIF compared to baseline with no significant difference between treatments. Both drugs were well tolerated with no differences in the tolerability profiles. CONCLUSIONS: Both PSE and montelukast are safe and equally effective in improving symptoms, QOL, and increasing nasal airflow in patients with SAR. The lack of insomnia in the pseudoephedrine group is ascribed to morning dosing with reduced blood levels during sleep. Funding: Merck & Co. Inc.
513
Montelukast and Desloratadine in the Treatment of Chronic (Perennial) Allergic Rhinitis: A Randomised, Double Blind, Placebo Controlled Study. M. Ciebiada1, M. Gorska-Ciebiada1, L. DuBuske2, P. Gorski1; 1Dept.Pneumology & Allergy, Medical University Lodz, Lodz, POLAND, 2Immunology Research Institute of New England, Boston, NH. RATIONALE: Montelukast hasn’t been evaluated for perennial rhinitis yet. The aim of this study was to investigate effects of 6-weeks lasting treatment of perennial rhinitis with desloratadine, montelukast alone and in combination. METHODS: We performed 32 weeks lasting randomized, double blind, placebo controlled, cross over study in 20 adult patients with: ≥2 years history, hyperresponsiveness to mites, total nasal symptom score ≥6 (congestion ≥2). There were four 6-weeks lasting treatment periods separated by 2-week wash outs. In each treatment period patients received: montelukast 10 mg or desloratadine 5 mg per day, or combination of montelukast 10 mg and desloratadine 5 mg or placebo. The sequence of taking pills was assigned randomly. Symptom score, physical examination, skin prick tests, spirometry and nasal lavage were performed the day before and in the last day of each treatment period . In nasal lavage ECP and eosinophil count were investigated. RESULTS: Total nasal symptom score : before the treatment 9,7; after placebo 8,3; after desloratadine 5,1; after montelukast 4,56, montelukast +desloratadine 4,04 . Improvement of nasal symptom score in subjects treated with montelukast alone or desloratadine alone was significant. Improvement after the treatment with a combination of both agents compared to each of them was slightly greater. The level of ECP in nasal lavage decreased after the treatment with all of agents separately but it was the greater after the combined medication. CONCLUSIONS: The treatment of chronic rhinitis with a combination of montelukast and desloratadine is more effective than with each of them alone.
510
SUNDAY
511
The Burden of Rhinitis in Children With Asthma
E. Civelek, C. N. Kocabas, C. Sackesen, F. Orhan, A. Tuncer, G. Adalioglu, B. E. Sekerel; Schol of medicine, HACETTEPE UNIVERSITY, Ankara, TURKEY. RATIONALE: Although the clinical association of allergic rhinitis and asthma appears to be stronger than has been reported previously, data for children is less clear and results observed in developing countries seem to differ from those observed in western populations. We have therefore intended to document the association of rhinitis with pediatric asthma in terms of caregivers’ perception, physician practice and file records. METHODS: 369 asthmatic children aged 3 to 16 years with at least oneyear follow-up were questioned along a questionnaire and their file records were evaluated retrospectively. RESULTS: A greater proportion of the respondents were male(63.7%), atopics(78.3%) and mild asthmatics(50.7%). House dust mite(50.7%) and grass pollens(46.9%), were the most commonly sensitized allergens. Although 5.4% of our study population regarded themselves as rhinitic and 23.8% had been diagnosed as allergic rhinitis according to the file records, 68.8% had consistent findings for allergic rhinitis and 57.7% of patients had required medications for rhinitis within the last year. Furthermore, 41.2% and 58.8% reported that their rhinitis symptoms caused a significant burden in their daily life and exacerbated their asthma, respectively. CONCLUSIONS: Although with regard to rhinitis prevalence determined in the survey and medications used for rhinitis, results appeared to be in agreement, there were certain differences in terms of the low frequency of rhinitis diagnosis observed in file records and many patients’
J ALLERGY CLIN IMMUNOL FEBRUARY 2005
lack of information regarding allergic rhinitis, indicating the need for a greater effort to identify and label rhinitics in asthma outpatient-clinics and to educate patients regarding their disease. Patients’ Willingness to Pay for Intranasal Corticosteroid Therapy: The Importance of Sensory Attributes S. Shah1, P. J. Mahadevia2, C. Leibman3, L. Kleinman2, L. O’Dowd3; 1Allergy & Asthma Consultants of NJ-PA, Collegeville, PA, 2MEDTAP International, Bethesda, MD, 3AstraZeneca, Wilmington, DE. RATIONALE: We evaluated patients’ willingness to pay (WTP) for intranasal corticosteroid (INS) products with differing sensory attribute profiles. METHODS: A cross-sectional survey of 120 patients with allergic rhinitis was conducted in 4 US allergy/immunology clinics. Participants chose between hypothetical INSs differing in intensity across 6 attributes (smell, taste, aftertaste, throat rundown, nose runout, and feel of spray) and monthly co-pays ($15, $30, $50). Attributes were characterized by 3 levels (eg, strong, weak, and none). Strength of preference was measured as marginal WTP to avoid higher-intensity levels. RESULTS: Patients were willing to pay $11 (95% confidence interval [CI]: $9 to $13) per month to avoid strong smell over no smell, $12 (95% CI: $10 to $14) to avoid strong taste over no taste, $20 (95% CI: $18 to $22) to avoid strong aftertaste over no aftertaste, $10 (95% CI: $9 to $12) to avoid excess throat rundown over no throat rundown, $11 (95% CI: $9 to $13) to avoid excess nose runout over none, and $6 (95% CI: $4 to $8) per month to avoid dry spray over moist spray. Comparing moderate to low intensity levels, aftertaste, throat rundown, and nose runout were still associated with a significant WTP. Income level was not associated with changes in WTP except for throat rundown. Patients with an income >$80,000 were willing to pay more to avoid excess throat rundown than those with an income <$40,000. CONCLUSIONS: Patients value certain INS product attributes and are willing to pay for an INS with favorable sensory attributes. Funding: AstraZeneca
512
Equivalence of Pseudoephedrine and Montelukast in the Treatment of Seasonal Allergic Rhinitis (SAR) F. M. Baroody, S. Mucha, M. deTineo, R. M. Naclerio; OtolaryngologyHead and Neck Surgery, The University of Chicago, Chicago, IL. RATIONALE: Both montelukast and pseudoephedrine are used for the treatment of SAR. Pseudoephedrine (PSE), while effective in the relief of nasal congestion, has unwanted side effects. Montelukast is effective and has no significant side effects. METHODS: We conducted a randomized, IRB-approved, double-blind study comparing the efficacy of PSE and montelukast in patients with ragweed SAR. Subjects with positive skin test to ragweed and a history of symptoms were recruited. After recording baseline nasal symptoms, nasal peak inspiratory flow (NPIF), and diurnal and nocturnal Rhinoconjunctivitis Quality of Life (QOL) scores, subjects were randomized to receive either PSE 240 mg or montelukast 10 mg PO daily in the morning for 2 weeks. They recorded nasal symptoms, and NPIF twice daily and filled QOL questionnaires and 2 tolerability profiles at study end. RESULTS: Both treatments resulted in significant improvements from baseline in all symptoms of allergic rhinitis as well as in all QOL domains. When changes from baseline were compared between treatments, there were no significant differences except in the symptom of nasal congestion where pseudoephedrine had superior efficacy compared to montelukast. Both treatments resulted in a significant increase in NPIF compared to baseline with no significant difference between treatments. Both drugs were well tolerated with no differences in the tolerability profiles. CONCLUSIONS: Both PSE and montelukast are safe and equally effective in improving symptoms, QOL, and increasing nasal airflow in patients with SAR. The lack of insomnia in the pseudoephedrine group is ascribed to morning dosing with reduced blood levels during sleep. Funding: Merck & Co. Inc.
513