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Allergist and pulmonologist prescribing of inhaled corticos-teroids for pregnant and nonpregnant women with asthma
S220
Abstracts
03 Allergist and Pulmonologist Prescribing of Inhaled Corticosteroids for Pregnant and Nonpregnent Women With Asthma N. K. Ostrom I, P. Park 2, M. Cruz-Rivera2; ]Allergy and Asthma Medical Group and Research Center, A.P.C., San Diego, CA, 2AstraZeneca, Wilmington, DE. RATIONALE: The US Food and Drug Administration recently upgraded the pregnancy category rating for budesonide dry-powder inhaler (BUD DPI) to Category B, making it the only ICS with a Category B rating. This survey assessed the awareness of this information and ICS prescribing practices among specialist physicians. METHODS: Fifteen allergists and 60 pulmonologists randomly selected from a marketing database, and meeting eligibility criteria, were surveyed to assess their medication prescribing practices and awareness of a Category B ICS. Specialists invited to complete the survey had been practicing for 2 to 25 years and spent at least 65% (allergists) or 30% (pulmonologists) of their practice time in an office or outpatient clinic. RESULTS: Specialists saw an average of 113 asthma patients per month, 24% of whom were females of childbearing age (15 to 44 years) and 3% of whom were pregnant and in need of asthma therapy. These physicians prescribed 1CSs more frequently than other classes of asthma medications for both nonpregnant (62%) and pregnant (68%) patients. They perceived a Category B pregnancy rating to be very important (7.7 of 10) in deciding which ICS to prescribe. However, only 56% were aware that an ICS, BUD DP1, was recently upgraded to Category B. CONCLUSIONS: Specialist prescribing practices are similar for pregnant and non-pregnant asthma patients, with ICSs prescribed more frequently than other medication classes. Increased awareness of the availability of a Category B ICS therapeutic agent will allow appropriate, informed consideration of treatment options for pregnant patients with persistent asthma.
Funding: AstraZeneca
J ALLERGY CLIN IMMUNOL FEBRUARY 2003
modality allows a method for using very low doses and less frequent dosing intervals to decrease both lung inflammation and AHR.
Funding: Children's Foundation of Wisconsin
605 Determinants of Airway Hyperresponsivenessin Mild Asthma C. M, Jackson, G. P. Currie, D. C. Lee, B. J, Lipworth; Asthma & Allergy Research Group, Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, Dundee, UNITED KINGDOM. RATIONALE: Patients with mild asthma may have coexisting severe airway hyperresponsiveness (AHR), although reasons for this are uncertain. We evaluated the factors determining AHR in mild asthmatics. METHODS: We performed a retrospective database evaluation of mild asthmatics with FEV I _>80% predicted, who had results for skin prick testing. Group A (n=92) had severe AHR (methacholine PD20 <100 lug) while group B (n=92) had mild AHR (methacholine PD20 >800 gg). Both groups were matched for age, sex, inhaled corticosteroid use and FEV]. RESULTS: From our database we found 361 patients with mild asthma, of whom 34% had a methacholine PD20 <100 lag and 38% had a methacholine PD20 _>800 lag. The methacholine PD20 geometric means (SE) of groups A and B were 25 (3) lag and 2907 (90) lag respectively. Mean values for FEVj were similar in group A versus group B (97% versus 100% predicted), while group A had a lower FEF25_75 (71% versus 81% predicted, p=0.007). A greater proportion of group A patients were sensitized to house dust mite (76% versus 54%. p=0.002). No significant differences were found between groups in terms of presence of rhinitis and sensitization to other individual aeroallergens. CONCLUSION: Sensitization to house dust mite and reduced small airway caliber were associated with severe AHR in mild asthma. Skin prick testing to common aeroallergens especially house dust mite, should be a routine part in the evaluation of asthmatic patients even with mild disease.
Funding: University of Dundee 604 The Efect of Budesonide Encapsulated in Liposomes on Airway Hyperresponsivenessin Experimental Asthma 606 onide Oropharyngeal Deposition of Inhaled Ciclesonide and Budesin Healthy Subjects S. D. N a n d e d k a r ], K. S, Konduri z, D. A. Rickaby 2, N. Duzgunes3; t Pediatrics, Medical College of Wisconsin, Milwaukee, WI, 2physiology, Medical College of Wisconsin, Milwaukee, WI, 3physiology/Microbiology, University of the Pacific School of Dentistry, San Francisco, CA. We have previously shown that budesonide encapsulated in liposomes, given once a week, decreased lung inflammation, equivalent to daily budesonide therapy in experimental asthma. Liposome composition is similar to lung surfactant and therefore, may aid in decreasing airway hyperresponsiveness (AHR). However, it is not clearly defined whether inhaled glucocorticoids have any effect on AHR. We hypothesized that weekly administration of budesonide encapsulated in liposomes would decrease AHR to methacholine in ovalbumin-sensitized C57B1/6 mice. AHR to methacholine was measured in spontaneously breathing, tracheally intubated mice that received increasing doses of methacholine (up to 3 mg/, intraperitoneally. The sensitized mice were divided into four groups and received for 4 weeks: (1) nebulized budesonide daily (2) nebulized budesonide encapsulated in liposomes, weekly (3) nebulized budesonide, weekly (4) no treatment, Normal mice were also maintained as additional controls. Only the budesonide encapsulated in liposomes, administered weekly, significantly decreased AHR to methacholine (p<0.05), and was comparable to normal mice. These data suggest that budesonide encapsulated in liposomes, administered weekly, can decrease lung inflammation and AHR. Daily budesonide, however, was noted to only decrease lung inflammation and did not provide any benefit in decreasing AHR to methacholine. This is the first study to show the efficacy of budesonide encapsulated in liposomes as a treatment that can be given weekly, to decrease AHR to methacholine. This new treatment
R, Nave, K. Zech, T. D. Bethke: Altana Pharma AG, Konstanz, GERMANY. RATIONALE: Ciclesonide is a novel topical glucocorticosteroid for the treatment of bronchial asthma. Activation by esterases in the lungs results in the formation of ciclesonide-active principle (ciclesonide-AP). In this study, the oropharyngeal deposition following inhalation of ciclesonide and budesonide via MDI, and the formation of ciclesonide-AP in the oropharynx were assessed. METHODS: In an open two-treatment, two-sequence study, 18 healthy subjects (9 men/9 women, median age 33 y, age range 22 to 55 y) inhaled, within a few minutes, a single dose of ciclesonide (800 lag) and budesonide (800 I.tg, Pulmicort TM)each, followed by a mouth wash with a solution containing 50% (v/v) ethanol at five separate time points (immediately, 15, 30, 45, and 60 min after successive inhalations). Rinsing solutions were assessed for ciclesonide, ciclesonide-AP, and budesonide; respective molar AUCso_60min were calculated and compared. RESULTS: Molar AUCs0_60min of ciclesonide-AP and budesonide were significantly different: 4% (95% confidence interval: 2-5%) of ciclesonide-AP was found in the mouth rinsing fluid within one hour after inhalation as compared with budesonide (reference). The sum of ciclesonide and ciclesonide-AP was 47% (95% confidence interval: 3859%) as compared with budesonide (reference). CONCLUSIONS: The oropharyngeal deposition of ciclesonide and ciclesonide-AP is only half of that of budesonide. The bioactivation of ciclesonide to its active principle within the upper oropharynx is low.
Funding: ALTANA Pharma AG
Abstracts
03 Allergist and Pulmonologist Prescribing of Inhaled Corticosteroids for Pregnant and Nonpregnent Women With Asthma N. K. Ostrom I, P. Park 2, M. Cruz-Rivera2; ]Allergy and Asthma Medical Group and Research Center, A.P.C., San Diego, CA, 2AstraZeneca, Wilmington, DE. RATIONALE: The US Food and Drug Administration recently upgraded the pregnancy category rating for budesonide dry-powder inhaler (BUD DPI) to Category B, making it the only ICS with a Category B rating. This survey assessed the awareness of this information and ICS prescribing practices among specialist physicians. METHODS: Fifteen allergists and 60 pulmonologists randomly selected from a marketing database, and meeting eligibility criteria, were surveyed to assess their medication prescribing practices and awareness of a Category B ICS. Specialists invited to complete the survey had been practicing for 2 to 25 years and spent at least 65% (allergists) or 30% (pulmonologists) of their practice time in an office or outpatient clinic. RESULTS: Specialists saw an average of 113 asthma patients per month, 24% of whom were females of childbearing age (15 to 44 years) and 3% of whom were pregnant and in need of asthma therapy. These physicians prescribed 1CSs more frequently than other classes of asthma medications for both nonpregnant (62%) and pregnant (68%) patients. They perceived a Category B pregnancy rating to be very important (7.7 of 10) in deciding which ICS to prescribe. However, only 56% were aware that an ICS, BUD DP1, was recently upgraded to Category B. CONCLUSIONS: Specialist prescribing practices are similar for pregnant and non-pregnant asthma patients, with ICSs prescribed more frequently than other medication classes. Increased awareness of the availability of a Category B ICS therapeutic agent will allow appropriate, informed consideration of treatment options for pregnant patients with persistent asthma.
Funding: AstraZeneca
J ALLERGY CLIN IMMUNOL FEBRUARY 2003
modality allows a method for using very low doses and less frequent dosing intervals to decrease both lung inflammation and AHR.
Funding: Children's Foundation of Wisconsin
605 Determinants of Airway Hyperresponsivenessin Mild Asthma C. M, Jackson, G. P. Currie, D. C. Lee, B. J, Lipworth; Asthma & Allergy Research Group, Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, Dundee, UNITED KINGDOM. RATIONALE: Patients with mild asthma may have coexisting severe airway hyperresponsiveness (AHR), although reasons for this are uncertain. We evaluated the factors determining AHR in mild asthmatics. METHODS: We performed a retrospective database evaluation of mild asthmatics with FEV I _>80% predicted, who had results for skin prick testing. Group A (n=92) had severe AHR (methacholine PD20 <100 lug) while group B (n=92) had mild AHR (methacholine PD20 >800 gg). Both groups were matched for age, sex, inhaled corticosteroid use and FEV]. RESULTS: From our database we found 361 patients with mild asthma, of whom 34% had a methacholine PD20 <100 lag and 38% had a methacholine PD20 _>800 lag. The methacholine PD20 geometric means (SE) of groups A and B were 25 (3) lag and 2907 (90) lag respectively. Mean values for FEVj were similar in group A versus group B (97% versus 100% predicted), while group A had a lower FEF25_75 (71% versus 81% predicted, p=0.007). A greater proportion of group A patients were sensitized to house dust mite (76% versus 54%. p=0.002). No significant differences were found between groups in terms of presence of rhinitis and sensitization to other individual aeroallergens. CONCLUSION: Sensitization to house dust mite and reduced small airway caliber were associated with severe AHR in mild asthma. Skin prick testing to common aeroallergens especially house dust mite, should be a routine part in the evaluation of asthmatic patients even with mild disease.
Funding: University of Dundee 604 The Efect of Budesonide Encapsulated in Liposomes on Airway Hyperresponsivenessin Experimental Asthma 606 onide Oropharyngeal Deposition of Inhaled Ciclesonide and Budesin Healthy Subjects S. D. N a n d e d k a r ], K. S, Konduri z, D. A. Rickaby 2, N. Duzgunes3; t Pediatrics, Medical College of Wisconsin, Milwaukee, WI, 2physiology, Medical College of Wisconsin, Milwaukee, WI, 3physiology/Microbiology, University of the Pacific School of Dentistry, San Francisco, CA. We have previously shown that budesonide encapsulated in liposomes, given once a week, decreased lung inflammation, equivalent to daily budesonide therapy in experimental asthma. Liposome composition is similar to lung surfactant and therefore, may aid in decreasing airway hyperresponsiveness (AHR). However, it is not clearly defined whether inhaled glucocorticoids have any effect on AHR. We hypothesized that weekly administration of budesonide encapsulated in liposomes would decrease AHR to methacholine in ovalbumin-sensitized C57B1/6 mice. AHR to methacholine was measured in spontaneously breathing, tracheally intubated mice that received increasing doses of methacholine (up to 3 mg/, intraperitoneally. The sensitized mice were divided into four groups and received for 4 weeks: (1) nebulized budesonide daily (2) nebulized budesonide encapsulated in liposomes, weekly (3) nebulized budesonide, weekly (4) no treatment, Normal mice were also maintained as additional controls. Only the budesonide encapsulated in liposomes, administered weekly, significantly decreased AHR to methacholine (p<0.05), and was comparable to normal mice. These data suggest that budesonide encapsulated in liposomes, administered weekly, can decrease lung inflammation and AHR. Daily budesonide, however, was noted to only decrease lung inflammation and did not provide any benefit in decreasing AHR to methacholine. This is the first study to show the efficacy of budesonide encapsulated in liposomes as a treatment that can be given weekly, to decrease AHR to methacholine. This new treatment
R, Nave, K. Zech, T. D. Bethke: Altana Pharma AG, Konstanz, GERMANY. RATIONALE: Ciclesonide is a novel topical glucocorticosteroid for the treatment of bronchial asthma. Activation by esterases in the lungs results in the formation of ciclesonide-active principle (ciclesonide-AP). In this study, the oropharyngeal deposition following inhalation of ciclesonide and budesonide via MDI, and the formation of ciclesonide-AP in the oropharynx were assessed. METHODS: In an open two-treatment, two-sequence study, 18 healthy subjects (9 men/9 women, median age 33 y, age range 22 to 55 y) inhaled, within a few minutes, a single dose of ciclesonide (800 lag) and budesonide (800 I.tg, Pulmicort TM)each, followed by a mouth wash with a solution containing 50% (v/v) ethanol at five separate time points (immediately, 15, 30, 45, and 60 min after successive inhalations). Rinsing solutions were assessed for ciclesonide, ciclesonide-AP, and budesonide; respective molar AUCso_60min were calculated and compared. RESULTS: Molar AUCs0_60min of ciclesonide-AP and budesonide were significantly different: 4% (95% confidence interval: 2-5%) of ciclesonide-AP was found in the mouth rinsing fluid within one hour after inhalation as compared with budesonide (reference). The sum of ciclesonide and ciclesonide-AP was 47% (95% confidence interval: 3859%) as compared with budesonide (reference). CONCLUSIONS: The oropharyngeal deposition of ciclesonide and ciclesonide-AP is only half of that of budesonide. The bioactivation of ciclesonide to its active principle within the upper oropharynx is low.
Funding: ALTANA Pharma AG