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Alcohol-Based Mouthwashes Following Inhaled Corticosteroids: To Use or Not To Use
AB160 Abstracts
607
Severe Geriatric Asthma: Efficacy of Omalizumab in a VA population P. Verma1, I. Randhawa2, W. B. Klaustermeyer1; 1VA Greater Los Angeles Healthcare System/UCLA Allergy-Immunology Division, Los Angeles, CA, 2UCLA Allergy-Immunology Division, Los Angeles, CA. RATIONALE: To compare clinical outcomes of omalizumab therapy in a severe asthma geriatric veteran population. METHODS: A retrospective, observational data analysis was performed over two years. Cohort outcome measures one year prior to omalizumab therapy were compared to one year of active treatment. Statistical analysis included two sample t-tests. RESULTS: The total number of patients enrolled was 17 with mean age of 61 years. Omalizumab therapy was associated with a significant reduction in acute asthma exacerbations requiring prednisone treatment (p<0.01), a significant improvement in forced expiratory volume in 1 second (FEV1) of 0.28 liters (p<0.01), and significantly higher Asthma Control Test (ACT) scores at 3 months of therapy (p50.043), 6 months of therapy (p50.039), and 12 months of therapy (p<0.01). Two out of 5 patients on daily prednisone for over 6 months were able to discontinue systemic steroid use within 3 months of omalizumab treatment. CONCLUSIONS: Our study suggests elderly patients with severe asthma demonstrate a significant positive clinical response to omalizumab.
608
MONDAY
Comparative Effectiveness Of Extrafine Hydrofluoroalkane Beclomethasone And Fluticasone In Asthma Management: A Real-world Observational Study From The United States D. B. Price1,2, P. Dorinsky3, P. Polos4, A. Burden2, J. von Ziegenweidt2, A. Chisholm2; 1University of Aberdeen, Foresterhill Health Centre, Aberdeen, UNITED KINGDOM, 2Research in Real Life Ltd, Norfolk, UNITED KINGDOM, 3Teva Pharmaceuticals, Horsham, PA, 4i3 Research, Cary, NC. RATIONALE: Relative effectiveness studies of inhaled corticosteroids (ICS) in real-life asthma populations are lacking. OBJECTIVE: To compare relative effectiveness of fluticasone propionate (FP) metered-dose inhaler (MDI) and extrafine hydrofluoroalkane beclomethasone dipropionate (EF HFA-BDP) (QvarÒ) MDI in real-life patients with asthma initiating ICS therapy. METHODS: Retrospective study using the Ingenix Normative Healthcare Information Database to assess asthma control over 1 year in patients (5-80 years) initiating ICS therapy as EF HFA-BDP or FP. Outcomes were asthma control (composite measure: no unplanned asthma hospitalization or emergency room [ER] attendance; no oral corticosteroids; no antibiotics _180mcg) and for lower respiratory infection, average daily SABA usage < number of exacerbations (no unplanned asthma hospitalization / ER attendance and no oral corticosteroids). Patients were matched on baseline demography and disease severity (age, gender, oral steroid prescriptions, asthma consultations not resulting in oral steroids, daily reliever medication usage). RESULTS: EF HFA-BDP was prescribed at significantly lower mean dose than FP (p<0.001). Patients initiating ICS as EF HFA-BDP had significantly greater odds of achieving asthma control (OR [95%CI]: 1.00 vs 0.79 [0.73,0.85]), a reflection of higher SABA usage among FP patients (p<0.001). Respiratory-related hospitalizations were significantly lower for EF HFA-BDP patients (OR [95%CI]: 1.00 vs 1.22 [1.10,1.34]). Exacerbation rates were comparable between treatments. CONCLUSIONS: Patients initiating ICS therapy with EF HFA-BDP were at least as likely to achieve successful asthma control as patients initiating therapy with FP despite EF HFA-BDP being prescribed a significantly lower dose. These data suggest ICS action site is important in achieving effective asthma management in real life.
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
609
Response to Budesonide/Formoterol Pressurized MeteredDose Inhaler (BUD/FM pMDI) by Patient's Sex in Non-Black and Black Populations With Asthma S. M. Meltzer1, S. L. Spector2, T. Uryniak3, U. J. Martin3; 1Allergy and Asthma Care Center of Southern California, Long Beach, CA, 2California Allergy & Asthma Medical Group, Los Angeles, CA, 3AstraZeneca LP, Wilmington, DE. RATIONALE: Differential effects of BUD/FM pMDI on absolute, but not percent, changes from baseline in pulmonary function variables have been described for males versus females in predominately white asthma populations. We tested these findings in a black population with moderate to severe persistent asthma. METHODS: Data from 2 double-blind, 12-week, randomized studies in non-black (white, Asian, or other; study I[n5190]:NCT00652002;Drugs. 2006;66:2235) or self-reported black (study II[n5308]:NCT00702325) adolescents and adults with asthma taking twice daily BUD/FM pMDI 320/9 mg or BUD (I:pMDI 320 mg; II:dry powder inhaler 360 mg) were assessed. RESULTS: Baseline percent predicted FEV1 values were similar in males (I,II:68.0%-69.8%) and females (I,II:67.4%-71.0%). Similarly, mean percent changes from baseline to treatment average in predose FEV1 were consistent in males and females (I:9.3% vs 9.5%; II:12.5% vs 8.2%). However, absolute improvements in pulmonary function variables were greater in males versus females: predose FEV1 (I:0.25 vs 0.15; II:0.23 vs 0.13 L), morning PEF (I:50.5 vs 25.9; II:31.4 vs 22.5 L/min), evening PEF (I:47.1 vs 25.5; II:26.0 vs 19.2 L/min). Reductions in total daily rescue medication use were similar between males and females receiving BUD/FM, respectively (I:0.9 vs 1.0; II:1.1 vs 1.3 inhalations/day). Improvements in pulmonary function and reductions in rescue medication in males and females were greater with BUD/FM versus BUD (both studies). CONCLUSIONS: In both black and non-black males and females with asthma of similar severity receiving BUD/FM treatment, percentage improvements in pulmonary function and reductions in rescue medication use were similar, while absolute improvements in pulmonary function were greater in males versus females.
610
Alcohol-Based Mouthwashes Following Inhaled Corticosteroids: To Use or Not To Use T. M. Nsouli1,2, E. J. McSorley-Gerard2, C. D. Schluckebier2, C. Davis2, M. Fakhriyazdi2, S. T. Nsouli2; 1Georgetown University School of Medicine, Washington, DC, 2Burke and Watergate Allergy and Asthma Research Centers, Washington, DC. RATIONALE: Alcohol-based mouthwashes (ABMW) are often recommended to asthmatic patients using inhaled corticosteroids (ICS) to prevent oral candidiasis and hoarseness. A large body of evidence from epidemiological studies conducted in different populations has supported the fact that regular alcohol consumption is strongly associated with an increased risk of oral cancers. Neoplasm of the oral cavity is the sixth leading cause of malignancy worldwide and is a cause of significant morbidity (Boyle JO, Strong EW. Oral Cavity Cancer in: Shah JP, eds. Cancer of the Head and Neck, BC Decker, London; 2001). However, the safety of long-term use of ABMW is still open to debate. METHODS: We reviewed the medical literature evaluating the potential risk of oral cancers due to regular use of ABMW. Some studies (Werner CW, Br Dent J. 2009; 2007: 488; McCullough MJ, Aust Dent J. 2008; 53:302) have suggested that regular and prolonged use of ABMW may increase the risk of oral cancer. RESULTS: Asthmatic patients treated with ICS frequently use ABMW to prevent oral adverse effects. The alcohol component of the mouthwash may contribute to an increased risk of developing oral malignancy. CONCLUSION: Considering the evidence that rinsing with water is as effective as ABMW to clear ICS particles from the oral cavity (Kelloway JS et al. Allergy Asthma Proc. 2001; 22:367), it would be prudent for allergists/immunologists prescribing ICS to advise their patients to utilize a non-ABMW or water as a safe effective mouth rinse, thus avoiding potential unnecessary increased risk of oral cancer.
607
Severe Geriatric Asthma: Efficacy of Omalizumab in a VA population P. Verma1, I. Randhawa2, W. B. Klaustermeyer1; 1VA Greater Los Angeles Healthcare System/UCLA Allergy-Immunology Division, Los Angeles, CA, 2UCLA Allergy-Immunology Division, Los Angeles, CA. RATIONALE: To compare clinical outcomes of omalizumab therapy in a severe asthma geriatric veteran population. METHODS: A retrospective, observational data analysis was performed over two years. Cohort outcome measures one year prior to omalizumab therapy were compared to one year of active treatment. Statistical analysis included two sample t-tests. RESULTS: The total number of patients enrolled was 17 with mean age of 61 years. Omalizumab therapy was associated with a significant reduction in acute asthma exacerbations requiring prednisone treatment (p<0.01), a significant improvement in forced expiratory volume in 1 second (FEV1) of 0.28 liters (p<0.01), and significantly higher Asthma Control Test (ACT) scores at 3 months of therapy (p50.043), 6 months of therapy (p50.039), and 12 months of therapy (p<0.01). Two out of 5 patients on daily prednisone for over 6 months were able to discontinue systemic steroid use within 3 months of omalizumab treatment. CONCLUSIONS: Our study suggests elderly patients with severe asthma demonstrate a significant positive clinical response to omalizumab.
608
MONDAY
Comparative Effectiveness Of Extrafine Hydrofluoroalkane Beclomethasone And Fluticasone In Asthma Management: A Real-world Observational Study From The United States D. B. Price1,2, P. Dorinsky3, P. Polos4, A. Burden2, J. von Ziegenweidt2, A. Chisholm2; 1University of Aberdeen, Foresterhill Health Centre, Aberdeen, UNITED KINGDOM, 2Research in Real Life Ltd, Norfolk, UNITED KINGDOM, 3Teva Pharmaceuticals, Horsham, PA, 4i3 Research, Cary, NC. RATIONALE: Relative effectiveness studies of inhaled corticosteroids (ICS) in real-life asthma populations are lacking. OBJECTIVE: To compare relative effectiveness of fluticasone propionate (FP) metered-dose inhaler (MDI) and extrafine hydrofluoroalkane beclomethasone dipropionate (EF HFA-BDP) (QvarÒ) MDI in real-life patients with asthma initiating ICS therapy. METHODS: Retrospective study using the Ingenix Normative Healthcare Information Database to assess asthma control over 1 year in patients (5-80 years) initiating ICS therapy as EF HFA-BDP or FP. Outcomes were asthma control (composite measure: no unplanned asthma hospitalization or emergency room [ER] attendance; no oral corticosteroids; no antibiotics _180mcg) and for lower respiratory infection, average daily SABA usage < number of exacerbations (no unplanned asthma hospitalization / ER attendance and no oral corticosteroids). Patients were matched on baseline demography and disease severity (age, gender, oral steroid prescriptions, asthma consultations not resulting in oral steroids, daily reliever medication usage). RESULTS: EF HFA-BDP was prescribed at significantly lower mean dose than FP (p<0.001). Patients initiating ICS as EF HFA-BDP had significantly greater odds of achieving asthma control (OR [95%CI]: 1.00 vs 0.79 [0.73,0.85]), a reflection of higher SABA usage among FP patients (p<0.001). Respiratory-related hospitalizations were significantly lower for EF HFA-BDP patients (OR [95%CI]: 1.00 vs 1.22 [1.10,1.34]). Exacerbation rates were comparable between treatments. CONCLUSIONS: Patients initiating ICS therapy with EF HFA-BDP were at least as likely to achieve successful asthma control as patients initiating therapy with FP despite EF HFA-BDP being prescribed a significantly lower dose. These data suggest ICS action site is important in achieving effective asthma management in real life.
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
609
Response to Budesonide/Formoterol Pressurized MeteredDose Inhaler (BUD/FM pMDI) by Patient's Sex in Non-Black and Black Populations With Asthma S. M. Meltzer1, S. L. Spector2, T. Uryniak3, U. J. Martin3; 1Allergy and Asthma Care Center of Southern California, Long Beach, CA, 2California Allergy & Asthma Medical Group, Los Angeles, CA, 3AstraZeneca LP, Wilmington, DE. RATIONALE: Differential effects of BUD/FM pMDI on absolute, but not percent, changes from baseline in pulmonary function variables have been described for males versus females in predominately white asthma populations. We tested these findings in a black population with moderate to severe persistent asthma. METHODS: Data from 2 double-blind, 12-week, randomized studies in non-black (white, Asian, or other; study I[n5190]:NCT00652002;Drugs. 2006;66:2235) or self-reported black (study II[n5308]:NCT00702325) adolescents and adults with asthma taking twice daily BUD/FM pMDI 320/9 mg or BUD (I:pMDI 320 mg; II:dry powder inhaler 360 mg) were assessed. RESULTS: Baseline percent predicted FEV1 values were similar in males (I,II:68.0%-69.8%) and females (I,II:67.4%-71.0%). Similarly, mean percent changes from baseline to treatment average in predose FEV1 were consistent in males and females (I:9.3% vs 9.5%; II:12.5% vs 8.2%). However, absolute improvements in pulmonary function variables were greater in males versus females: predose FEV1 (I:0.25 vs 0.15; II:0.23 vs 0.13 L), morning PEF (I:50.5 vs 25.9; II:31.4 vs 22.5 L/min), evening PEF (I:47.1 vs 25.5; II:26.0 vs 19.2 L/min). Reductions in total daily rescue medication use were similar between males and females receiving BUD/FM, respectively (I:0.9 vs 1.0; II:1.1 vs 1.3 inhalations/day). Improvements in pulmonary function and reductions in rescue medication in males and females were greater with BUD/FM versus BUD (both studies). CONCLUSIONS: In both black and non-black males and females with asthma of similar severity receiving BUD/FM treatment, percentage improvements in pulmonary function and reductions in rescue medication use were similar, while absolute improvements in pulmonary function were greater in males versus females.
610
Alcohol-Based Mouthwashes Following Inhaled Corticosteroids: To Use or Not To Use T. M. Nsouli1,2, E. J. McSorley-Gerard2, C. D. Schluckebier2, C. Davis2, M. Fakhriyazdi2, S. T. Nsouli2; 1Georgetown University School of Medicine, Washington, DC, 2Burke and Watergate Allergy and Asthma Research Centers, Washington, DC. RATIONALE: Alcohol-based mouthwashes (ABMW) are often recommended to asthmatic patients using inhaled corticosteroids (ICS) to prevent oral candidiasis and hoarseness. A large body of evidence from epidemiological studies conducted in different populations has supported the fact that regular alcohol consumption is strongly associated with an increased risk of oral cancers. Neoplasm of the oral cavity is the sixth leading cause of malignancy worldwide and is a cause of significant morbidity (Boyle JO, Strong EW. Oral Cavity Cancer in: Shah JP, eds. Cancer of the Head and Neck, BC Decker, London; 2001). However, the safety of long-term use of ABMW is still open to debate. METHODS: We reviewed the medical literature evaluating the potential risk of oral cancers due to regular use of ABMW. Some studies (Werner CW, Br Dent J. 2009; 2007: 488; McCullough MJ, Aust Dent J. 2008; 53:302) have suggested that regular and prolonged use of ABMW may increase the risk of oral cancer. RESULTS: Asthmatic patients treated with ICS frequently use ABMW to prevent oral adverse effects. The alcohol component of the mouthwash may contribute to an increased risk of developing oral malignancy. CONCLUSION: Considering the evidence that rinsing with water is as effective as ABMW to clear ICS particles from the oral cavity (Kelloway JS et al. Allergy Asthma Proc. 2001; 22:367), it would be prudent for allergists/immunologists prescribing ICS to advise their patients to utilize a non-ABMW or water as a safe effective mouth rinse, thus avoiding potential unnecessary increased risk of oral cancer.