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Comparison of Nebulized Budesonide Versus Oral Steroids for the Treatment of Outpatient Asthma in Children Aged 1 to 8 Years
S158 Abstracts
602
Predose Forced Expiratory Flow Between 25% and 75% (FEF25-75%) in Inhaled Corticosteroid (ICS)-Dependent Patients With Mild to Moderate or Moderate to Severe Persistent Asthma Receiving Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) D. S. Pearlman1, T. Uryniak2, C. D. O’Brien2, U. J. Martin2; 1Colorado Allergy and Asthma Centers, PC, Denver, CO, 2AstraZeneca, LP, Wilmington, DE. RATIONALE: To assess changes in FEF25-75% in patients with mild to severe asthma treated with BUD/FM previously receiving ICSs. METHODS: Two 12-week, randomized, double-blind studies were conducted in patients aged 12 years requiring ICS maintenance therapy. Study I (SD-039-0717; N 5 596): patients with moderate to severe asthma underwent a 2-week run-in period on BUD pMDI 80 mg 32 inhalations bid and then received BUD/FM pMDI 160/4.5 mg 32 inhalations bid, BUD pMDI 160 mg 1 FM DPI 4.5 mg 32 inhalations bid, BUD 160 mg 32 inhalations bid, FM DPI 4.5 mg 32 inhalations bid, or placebo. Study II (SD-039-0716; N 5 480): patients with mild to moderate asthma underwent a 2-week run-in on placebo and then received BUD/FM pMDI 80/ 4.5 mg 32 inhalations bid, BUD pMDI 80 mg 32 inhalations bid, FM DPI 4.5 mg 32 inhalations bid, or placebo. Mean 6 SD percentage change from baseline to treatment average in predose FEF25-75% was assessed. RESULTS: Study I: FEF25-75% improved with BUD/FM (16.3% 6 24.0%), BUD 1 FM (14.6 6 25.4%), and BUD (8.4% 6 28.9%) and declined with FM (-5.7% 6 24.1%) and placebo (-8.3% 6 34.7%). Study II: improvements in FEF25-75% were highest with BUD/FM (35.9% 6 45.1%), BUD (27.3% 6 50.5%), and FM (18.3% 6 39.4%) and lowest with placebo (3.2% 6 37.6%). CONCLUSIONS: In patients previously on ICS, improvements in predose FEF25-75% were observed with all ICS-containing treatments versus placebo. Greater improvements in predose FEF25-75% were observed with the addition of a long-acting b2-adrenergic agonist (BUD/FM) to the treatment regimen.
MONDAY
603
Short Acting Beta Agonist Utilization and Risk of Asthma Exacerbation Among a Commercially Insured Pediatric Population in the United States H. Silver1, C. M. Blanchette1,2, H. Petersen1, S. Kamble3, D. Meddis4, B. Gutierrez4; 1Lovelace Respiratory Research Institute, Albuquerque, NM, 2 University of North Carolina School of Pharmacy, Chapel Hill, NC, 3University of North Carolina, Charlotte, NC, 4AstraZeneca, Wilmington, DE. RATIONALE: High utilization of short-acting beta2 agonists (SABA) is associated with asthma exacerbations, however a threshold in not well defined. We explored SABA utilization patterns in order to identify a threshold associated with asthma exacerbation. METHODS: A retrospective cohort study conducted using PHARMetrics database included pediatrics (aged 6-17 years; n 5 33,951) with asthma and two-year continuous enrollment between 7/2003-6/2007, 1 hospitalization/emergency department (ED) or 2 outpatient claims of ICD-9 code 493.XX and 1 SABA or asthma controller claim in each of the two years of observation. Diseases requiring chronic oral steroid use were exclusionary. Second-year SABA utilization was converted to canister-count/year and categorized into 1): 0, ½-2, 2½-6, 6½-12, and >12; and 2) 0-5 and 6. Risk of a composite asthma exacerbation, defined as an oral steroid claim, hospitalization, or ED visit, was assessed using logistic regression, controlling for age, sex, region, second-year asthma controller use, several first-year severity measures/comorbidities. RESULTS: Of the cohort, 24.0% had 0 SABA canisters/year, 46.3% had ½-2, 22.8% had 2½-6, 5.3% had 6½-12, and 1.6% had >12 whereas 9.3% had 6 (90.7% 0-5). Compared to 0 canisters/year, higher SABA utilization and high exacerbation risk were observed [½-2 (OR:1.69; CI:1.531.88), 2½-6 (OR:2.41; CI:2.15-2.69), 6½-12 (OR: 3.08; CI:2.64-3.61), and >12 (OR:2.94; CI:2.28-3.77)] Patients with 6 canisters/year (compared with 0-5) had a 60% greater exacerbation risk (OR:1.60; CI:1.44-1.79).
J ALLERGY CLIN IMMUNOL FEBRUARY 2009
CONCLUSIONS: Use of SABA signaled increased exacerbation risk in asthmatics. A threshold of 6 SABA canisters/year suggests a need for re-examining asthma treatment in the pediatric population.
604
Comparison of Nebulized Budesonide Versus Oral Steroids for the Treatment of Outpatient Asthma in Children Aged 1 to 8 Years D. Skoner, J. Koehrsen, A. Patel, H. Barth, D. Gentile; Allegheny General Hospital, Pittsburgh, PA. RATIONALE: The standard of care for acute asthma includes the use of inhaled b-agonists and bursts of oral steroids. However, there is a growing concern regarding the safety of repeated bursts of oral steroids for the treatment of acute asthma. The purpose of this study was to determine whether nebulized budesonide and usual care were equally effective in preventing asthma relapse in pediatric outpatient subjects. METHODS: This was an open-label, randomized parallel-group study of subjects 1-8 years of age discharged from an outpatient setting for acute asthma. Enrolled subjects were randomized to treatment with 0.5 mg budesonide BID via nebulizer x 21 days or to usual care (albuterol 1/2 oral steroids). Subjects were followed for 21 days to evaluate the frequency of relapse which was defined as an unscheduled visit for worsening asthma. RESULTS: Forty-five subjects were enrolled, including 38% female and 29% non-white subjects. Fifteen of 21 subjects randomized to nebulized budesonide treatment completed follow-up, and 16 of 24 randomized to usual treatment completed follow-up. Relapse rates were similar in both groups and consisted of only one subject per group. SUMMARY: These results provide preliminary evidence that treatment with nebulized budesonide and usual care were equally effective in preventing asthma relapse in pediatric patients treated in an outpatient setting. Futures studies need to expand this sample size and examine other outcomes related to both safety and efficacy.
605
Asthma Control and Patient Satisfaction After Treatment of Omalizumab Among Moderate to Severe Asthma: 1Year Observation W. Maek-a-nantawat, U. Silachamroon; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. RATIONALE: Of moderate to severe asthma, total control of symptoms is the optimal goal of treatment. Though maximal dose of inhaled steroid combined with inhaled long acting bronchodilator is reached, some patients still do not achieve the outcome success and satisfy their daily life with activity limitation. Omalizumab has been approved for uncontrolled severe atopic asthma and released in Thailand since 2006. METHODS: The cohort study is aimed to evaluate clinical outcome and satisfaction of omalizumab as an adjunctive treatment of asthma among the patients unsatisfied in current optimal treatment. Clinical assessment and patient satisfaction were performed every visit at Allergy clinic of Hospital for Tropical Diseases, Bangkok, Thailand. RESULTS: 9 patients with the median age in years (range) of 58 (49-71), 5 males and 4 females, had been treated with omalizumab for the median time in weeks (range) of 36 (8-48) weeks. All were moderate to severe asthma and needed higher dose inhaled, oral or injected steroid to relieve exacerbation and control their asthma attack. Baseline serum total IgE ranged from 18.4-1051 IU/mL. 5/9 (55.6%) showed their satisfaction and good response to omalizumab pertaining to total control (60%), and decreased morbidity and medication (100%). The median onset time (range) of clinical response was 13 (6-16) weeks.1/4 of non-responders was intrinsic asthma. No serious adverse event related to omalizumab was reported. CONCLUSIONS: In a case of uncontrolled severe atopic asthma, omalizumab is considered to be adjunctive therapy to maintain asthma control, reduce exacerbation of symptoms and satisfy his daily life.
602
Predose Forced Expiratory Flow Between 25% and 75% (FEF25-75%) in Inhaled Corticosteroid (ICS)-Dependent Patients With Mild to Moderate or Moderate to Severe Persistent Asthma Receiving Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) D. S. Pearlman1, T. Uryniak2, C. D. O’Brien2, U. J. Martin2; 1Colorado Allergy and Asthma Centers, PC, Denver, CO, 2AstraZeneca, LP, Wilmington, DE. RATIONALE: To assess changes in FEF25-75% in patients with mild to severe asthma treated with BUD/FM previously receiving ICSs. METHODS: Two 12-week, randomized, double-blind studies were conducted in patients aged 12 years requiring ICS maintenance therapy. Study I (SD-039-0717; N 5 596): patients with moderate to severe asthma underwent a 2-week run-in period on BUD pMDI 80 mg 32 inhalations bid and then received BUD/FM pMDI 160/4.5 mg 32 inhalations bid, BUD pMDI 160 mg 1 FM DPI 4.5 mg 32 inhalations bid, BUD 160 mg 32 inhalations bid, FM DPI 4.5 mg 32 inhalations bid, or placebo. Study II (SD-039-0716; N 5 480): patients with mild to moderate asthma underwent a 2-week run-in on placebo and then received BUD/FM pMDI 80/ 4.5 mg 32 inhalations bid, BUD pMDI 80 mg 32 inhalations bid, FM DPI 4.5 mg 32 inhalations bid, or placebo. Mean 6 SD percentage change from baseline to treatment average in predose FEF25-75% was assessed. RESULTS: Study I: FEF25-75% improved with BUD/FM (16.3% 6 24.0%), BUD 1 FM (14.6 6 25.4%), and BUD (8.4% 6 28.9%) and declined with FM (-5.7% 6 24.1%) and placebo (-8.3% 6 34.7%). Study II: improvements in FEF25-75% were highest with BUD/FM (35.9% 6 45.1%), BUD (27.3% 6 50.5%), and FM (18.3% 6 39.4%) and lowest with placebo (3.2% 6 37.6%). CONCLUSIONS: In patients previously on ICS, improvements in predose FEF25-75% were observed with all ICS-containing treatments versus placebo. Greater improvements in predose FEF25-75% were observed with the addition of a long-acting b2-adrenergic agonist (BUD/FM) to the treatment regimen.
MONDAY
603
Short Acting Beta Agonist Utilization and Risk of Asthma Exacerbation Among a Commercially Insured Pediatric Population in the United States H. Silver1, C. M. Blanchette1,2, H. Petersen1, S. Kamble3, D. Meddis4, B. Gutierrez4; 1Lovelace Respiratory Research Institute, Albuquerque, NM, 2 University of North Carolina School of Pharmacy, Chapel Hill, NC, 3University of North Carolina, Charlotte, NC, 4AstraZeneca, Wilmington, DE. RATIONALE: High utilization of short-acting beta2 agonists (SABA) is associated with asthma exacerbations, however a threshold in not well defined. We explored SABA utilization patterns in order to identify a threshold associated with asthma exacerbation. METHODS: A retrospective cohort study conducted using PHARMetrics database included pediatrics (aged 6-17 years; n 5 33,951) with asthma and two-year continuous enrollment between 7/2003-6/2007, 1 hospitalization/emergency department (ED) or 2 outpatient claims of ICD-9 code 493.XX and 1 SABA or asthma controller claim in each of the two years of observation. Diseases requiring chronic oral steroid use were exclusionary. Second-year SABA utilization was converted to canister-count/year and categorized into 1): 0, ½-2, 2½-6, 6½-12, and >12; and 2) 0-5 and 6. Risk of a composite asthma exacerbation, defined as an oral steroid claim, hospitalization, or ED visit, was assessed using logistic regression, controlling for age, sex, region, second-year asthma controller use, several first-year severity measures/comorbidities. RESULTS: Of the cohort, 24.0% had 0 SABA canisters/year, 46.3% had ½-2, 22.8% had 2½-6, 5.3% had 6½-12, and 1.6% had >12 whereas 9.3% had 6 (90.7% 0-5). Compared to 0 canisters/year, higher SABA utilization and high exacerbation risk were observed [½-2 (OR:1.69; CI:1.531.88), 2½-6 (OR:2.41; CI:2.15-2.69), 6½-12 (OR: 3.08; CI:2.64-3.61), and >12 (OR:2.94; CI:2.28-3.77)] Patients with 6 canisters/year (compared with 0-5) had a 60% greater exacerbation risk (OR:1.60; CI:1.44-1.79).
J ALLERGY CLIN IMMUNOL FEBRUARY 2009
CONCLUSIONS: Use of SABA signaled increased exacerbation risk in asthmatics. A threshold of 6 SABA canisters/year suggests a need for re-examining asthma treatment in the pediatric population.
604
Comparison of Nebulized Budesonide Versus Oral Steroids for the Treatment of Outpatient Asthma in Children Aged 1 to 8 Years D. Skoner, J. Koehrsen, A. Patel, H. Barth, D. Gentile; Allegheny General Hospital, Pittsburgh, PA. RATIONALE: The standard of care for acute asthma includes the use of inhaled b-agonists and bursts of oral steroids. However, there is a growing concern regarding the safety of repeated bursts of oral steroids for the treatment of acute asthma. The purpose of this study was to determine whether nebulized budesonide and usual care were equally effective in preventing asthma relapse in pediatric outpatient subjects. METHODS: This was an open-label, randomized parallel-group study of subjects 1-8 years of age discharged from an outpatient setting for acute asthma. Enrolled subjects were randomized to treatment with 0.5 mg budesonide BID via nebulizer x 21 days or to usual care (albuterol 1/2 oral steroids). Subjects were followed for 21 days to evaluate the frequency of relapse which was defined as an unscheduled visit for worsening asthma. RESULTS: Forty-five subjects were enrolled, including 38% female and 29% non-white subjects. Fifteen of 21 subjects randomized to nebulized budesonide treatment completed follow-up, and 16 of 24 randomized to usual treatment completed follow-up. Relapse rates were similar in both groups and consisted of only one subject per group. SUMMARY: These results provide preliminary evidence that treatment with nebulized budesonide and usual care were equally effective in preventing asthma relapse in pediatric patients treated in an outpatient setting. Futures studies need to expand this sample size and examine other outcomes related to both safety and efficacy.
605
Asthma Control and Patient Satisfaction After Treatment of Omalizumab Among Moderate to Severe Asthma: 1Year Observation W. Maek-a-nantawat, U. Silachamroon; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. RATIONALE: Of moderate to severe asthma, total control of symptoms is the optimal goal of treatment. Though maximal dose of inhaled steroid combined with inhaled long acting bronchodilator is reached, some patients still do not achieve the outcome success and satisfy their daily life with activity limitation. Omalizumab has been approved for uncontrolled severe atopic asthma and released in Thailand since 2006. METHODS: The cohort study is aimed to evaluate clinical outcome and satisfaction of omalizumab as an adjunctive treatment of asthma among the patients unsatisfied in current optimal treatment. Clinical assessment and patient satisfaction were performed every visit at Allergy clinic of Hospital for Tropical Diseases, Bangkok, Thailand. RESULTS: 9 patients with the median age in years (range) of 58 (49-71), 5 males and 4 females, had been treated with omalizumab for the median time in weeks (range) of 36 (8-48) weeks. All were moderate to severe asthma and needed higher dose inhaled, oral or injected steroid to relieve exacerbation and control their asthma attack. Baseline serum total IgE ranged from 18.4-1051 IU/mL. 5/9 (55.6%) showed their satisfaction and good response to omalizumab pertaining to total control (60%), and decreased morbidity and medication (100%). The median onset time (range) of clinical response was 13 (6-16) weeks.1/4 of non-responders was intrinsic asthma. No serious adverse event related to omalizumab was reported. CONCLUSIONS: In a case of uncontrolled severe atopic asthma, omalizumab is considered to be adjunctive therapy to maintain asthma control, reduce exacerbation of symptoms and satisfy his daily life.