Underdiagnosis of Esophageal Candidiasis in Asthma Patients

S222 Abstracts

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J ALLERGY CLIN IMMUNOL FEBRUARY 2008

Effectiveness of Adding Montelukast to Low Dose Inhaled Corticosteroids in Patients with Uncontrolled Asthma and Allergic Rhinitis C. Koch1, R. McIvor2, S. Coyle3, N. Harvey1, S. Foucart1, F. Psaradellis4, J. Sampalis4, J. Fitzgerald5; 1Merck Frosst Canada Ltd., Pointe-Claire, QC, Canada, 2McMaster University, Hamilton, ON, Canada, 3Misericordia Health Center, Winnipeg, MB, Canada, 4JSS Medical Research, Westmount, QC, Canada, 5Vancouver Coastal Health Research Institute, Vancouver, BC, Canada. RATIONALE: The presence of Allergic Rhinitis (AR) which commonly co-exists with asthma worsens the asthma symptoms. For asthmatic patients not controlled with Inhaled Corticosteroids (ICS), the addition of montelukast, a leukotriene receptor, may be beneficial. METHODS: An 8-week Canadian multicenter, open-label, prospective cohort study of uncontrolled adult asthma patients treated with ICS received montelukast sodium 10 mg, once daily. A total of 319 uncontrolled asthma patients were enrolled, of which 192 patients had concurrent AR. Uncontrolled asthma was defined according to the Canadian Asthma Consensus Guidelines. Efficacy outcome measures included the change in Asthma Control Questionnaire (ACQ) score between baseline and 8 weeks of treatment and the proportion of patients with an ACQ score < 1.5. Secondary outcome measures included patient and physician global satisfaction with treatment. RESULTS: At the time of this report, 181 (94.3%) patients with AR have completed 8 weeks of treatment and 11 (6.1%) discontinued. The mean (SD) age was 42.3 (15.6) years[M1]. After 8 weeks of treatment the mean (SD) ACQ score changed from 1.94 (0.74) to 0.85 (0.74) (P50.001) which is clinically significant as it exceeds the validated value of 0.5. Furthermore, 145 (75.5%) of patients are considered controlled i.e. ACQ score of < 1.5. The proportion of patients and physicians reporting being satisfied with treatment at baseline and at 8 weeks increased from 40% to 89% (P<0.001) and 45% to 92% (P<0.001) respectively. CONCLUSIONS: Montelukast is effective and well-tolerated add-on therapy to the ICS treatment for the management of asthma in patients with AR. Funding: Merck Frosst Canada Ltd.

Asthma Control Test in a School Based Asthma Screening E. L. Goldstein, D. J. Dvorin; The Asthma Center Education and Research Fund, Philadelphia, PA. RATIONALE: Examine usefulness of the Asthma Control Test (ACT) and Childhood Asthma Control Test (C-ACT) compared to pulmonary function tests (PFTs) and SaO2 in school based asthma screenings. METHODS: Part of a nationwide asthma screening, 600 packets were sent home with children (K-8) attending 3 private schools. Packets contained introductory letters, registration, demographic information, release forms, age-specific child, and parent questionnaires including ACT/C-ACT. Spirometry, peak flow, resting SaO2, and height were obtained. Analysis compared functional parameters (PFTs and SaO2) versus ACT/C-ACT in students with known asthma. RESULTS: Of 114 screened (ages 4-13, mean 8.6 6 2.2, 1.1 M/F), 25 (22%) had asthma history, with 15 (60%) completing the ACT/C-ACT. The mean ACT/C-ACT score was 21.3 6 4.7, range 11-25. Mean SaO2 was 98.8% 6 0.9 and mean PFTs (precent of predicted) were PEF 98.7% 6 20.8, FVC 100.1% 6 19.7, FEV1 97.8% 6 17.3, FEV1/FVC 87.1% 6 8.2, FEF25-75 92.2% 6 21.7, and FET100% 2.6 seconds 6 1.0. Of 3 students with ACT/C-ACT scores  19 (uncontrolled asthma), 0 had FEV1  80% predicted and 2 (66.7%) had 1 or more other abnormal PFTs. Of 12 students with ACT/C-ACT scores > 19 (controlled asthma), 3 (25%) had FEV1  80% predicted and a total of 8 (66.7%) had 1 or more other abnormal PFTs. Analysis showed no significant correlations (all jrj < 0.45) between ACT/C-ACT scores and individual functional parameters. CONCLUSIONS: Using ACT/C-ACT in school based asthma screenings may be helpful tools in assessing asthma control and do not necessarily correlate with functional parameters.

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Childhood Asthma in Pediatric Practices: Still Out of Control G. R. Bloomberg1, R. Sterkel2, C. Banister3, J. Epstein4, 5 J. Bruns , L. Swerczek5, S. Wells5, J. Garbutt6; 1Washington University School of Medicine, Dep’t of Pediatrics, Div. Allergy and Pulmonary Medicine, St Louis, MO, 2Washington University School of Medicine, Dep’t of Pediatrics, St Louis, MO, 3Washington University School of Medicine, Dep’t of Medicine, St Louis, MO, 4Washington University School of Medicine, Dep’t of Pediatrics, St Louis, MO, 5BJC Healthcare, St Louis, MO, 6Washington University School of Medicine, Dep’t of Pediatrics, Dep’t of Medicine, St Louis, MO. RATIONALE: Assessment of asthma morbidity and management status is essential to recommending specific interventions. METHODS: Asthma morbidity was assessed using a brief questionnaire administered to parents of children, 5-12 years of age, with persistent asthma. Parents had been recruited from local, pediatric practices prior to an intervention study. Short-term morbidity was assessed from symptoms, short acting b2-agonist usage, and activity limitations over the prior 2 weeks. Long-term morbidity was assessed from exacerbations requiring oral corticosteroid over 3 months and ED/hospitalization over 12 months. These data were used to generate the child’s level of control (well, partially, and poorly controlled) and matched with current use of controller medications. RESULTS: 362 children were recruited from 95 general practice pediatricians, mostly in suburban areas, with 61% Caucasian, 62% male, and 22% Medicaid insurance; 73% reported using a controller medication daily. 82% reported an acute exacerbation in past 12 months but only 48% had an asthma maintenance visit in the past 6 months. Asthma was ‘‘well controlled’’ for 24% of children, ‘‘partially controlled’’ for 20%, and ‘‘poorly controlled’’ for 52%. Step level management per guideline recommendations indicated that 74% of children were being inadequately treated.

CONCLUSIONS: Data about asthma morbidity and medication use were easy to collect using a brief questionnaire. More than half of children in this community have poorly controlled asthma despite access to private care and widespread prescribing of controller medications. More frequent scheduled asthma management assessments, for morbidity and treatment adjustment as necessary, are needed to improve asthma control. Funding: AHRQ (#HS15378)

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Underdiagnosis of Esophageal Candidiasis in Asthma Patients P. Giavina-Bianchi, M. Vivolo Aun, C. Leite Costa Garcia, M. Rosimeire Ribeiro, J. Kalil; Clinical Immunology and Allergy Division, University of Sa˜o Paulo, Sa˜o Paulo, BRAZIL. RATIONALE: Inhaled glucocorticosteroids are currently the most effective anti-inflammatory medications for the treatment of persistent asthma. Local adverse effects include oropharyngeal candidiasis, dysphonia and coughing from upper airway irritation. Mouth washing, eat after drug administration, new formulations and devices that reduce oropharyngeal deposition may minimize such effects. Esophageal candidiasis is a rare reported adverse effect of inhaled corticosteroid use and its prevalence is not well known. METHODS: We describe four cases of esophageal candidiasis in patients with asthma taking inhaled budesonide. RESULTS: Four asthma patients were being treated with inhaled combination of budesonide and formoterol. Three were taking 800/24 micrograms/day, two with aerolyzer and one with turbuhaler. The other one were taking 1600/24 micrograms/day with aerolyzer. Although none of them were presenting signs or symptoms of oropharyngeal candidiasis, they had dyspeptic pain and heartburn. They reported no oral steroid use in the past three months. Patients did not present fever, neither diabetes mellitus, nor immunodeficiency. Esophagogastroduodenoscopy with biopsy confirmed the diagnosis of candidal esophagitis. Treatment with fluconazole eliminated infection in all patients. CONCLUSIONS: Although a study has shown 37% of prevalence of esophageal candidiasis among patients treated with inhaled fluticasone propionate, it is an underdiagnosed disease. Asthma patients on inhaled

Abstracts S223

J ALLERGY CLIN IMMUNOL VOLUME 121, NUMBER 2

corticosteroids with symptoms of esophagitis should be investigated for esophageal candidiasis. Funding: FMUSP

CONCLUSIONS: There exists cross-reactivity between latex and tobacco allergens. Smoker patients with IgE response to tobacco may be a risk population for latex sensitisation.

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Cross-reactivity Between Tobacco and Latex in Asthmatic Sensitive Patients A. Armentia1, B. Bartolome2, J. Garcia Ortiz1, M. Sanchis1, R. de la Fuente1, J. Vega1, A. Fernandez1; 1HOSPITAL RIO HORTEGA, VALLADOLID, SPAIN, 2LABORATORIOS BIAL ARISTEGUI, BILBAO, SPAIN. RATIONALE: Recently, allergen cross-reactivity was observed between tobacco and other species of Solanaceae family (tomato, potato, aubergine). We have recently studied IgE response to tobacco in asthmatic patients sensitised to Lolium perenne (rye grass pollen) and have found that 30% of tobacco responsive patients had also latex sensitisation. The aim of our study was to investigate the possibility of cross-reactivity among tobacco and latex in asthmatic patients with IgE response to latex. METHODS: We performed a study on tobacco and latex exposure in 15 patients suffered from asthma due to latex sensitisation that were randomly chosen from our data base of sensitive-latex patients. All these patients were tested in order to try to identify tobacco and latex as possible allergens that might cause clinical specific response (prick-tests, specific IgE to tobacco, latex and related allergens, bronchial challenge (BC), patch tests with tobacco, latex and nicotine, rubbing tests) and immunological response: immunoblotting and immunoblotting-inhibition. RESULTS: Positive prick and BC with specific IgE >0,35 kU/L to tobacco was demonstrated in 11 asthmatics that were also sensitised to rye grass. Tobacco IgE level was related with sensitisation to latex (p < 0.002), but not with other vegetables that belong to the Solanaceae family. Immunoblotting-inhibition showed the existence of cross-reactivity between tobacco and latex.

Chronic Cough and Asthma Symptom Associated with Conifer Pollen in Fukuoka, Japan R. Kishikawa, T. Shimoda, S. Shoji, M. Imaoka, N. Kamikawaji, H. Nogami, H. Aso, K. Yokota, S. Nishima; The Minami Fukuka Hospital Clinical Reserch Center, Fukuoka, JAPAN. RATIONALE: Japanese Cedar/cypress pollen is the important allergen which exacerbates seasonal allergic symptoms. To clarify the characteristics of conifer pollen allergy and notify the patients with cedar hypersensitivity for preventing and treating their symptoms. METHODS: We monitored atmospheric allergic conifer pollen by PAAA protocol at our hospital every year. We examined the chief complaints and consequence of the examinations of new patients with cedar hypersensitivity visited to our hospital suffering from the symptoms diagnosed by CAP-RAST from January to June for 4 years, 2004 to 2007. We investigated retrospectively in our hospital. RESULTS: The high to low concentration atmospheric conifer pollen was monitored from February to April mainly. The forty percent of total 1772 patients have positive Japanease cedar specific antibody. The chief complaints were asthma attack with pollinosis, dry cough, rhino-conjunctivitis, oral allergy syndrome, urticaria, sleep apnea syndrome and so on. After dispersing pollen about 20% of the patients have the prolonged symptoms and visited to our hospital as new patients suffering from severe chronic dry cough and sleep disturbance. CONCLUSIONS: We found the patients with the Japanese Cedar hypersensitivity have severe and persistent lower respiratory symptoms. We suggested it is important to know chronic cough symptom after conifer pollen dispersing for the patients and medical doctors to prevent and treat pollen allergy even after the pollination season in Japan.

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Observed Subject Utilization of Electronic PEF Meters Integrated With an Electronic Diary in a Randomized Clinical Trial S. Raymond; PHT Corporation, Charlestown, MA. RATIONALE: Self-reported peak flow data are known to be inaccurate when entered in paper diaries. The integration of PHT’s eSenseä PiKo(R) devices was described at the 2004 AAAAI Annual Meeting, as a way to improve self-reported PEF data quality. In a study of subjects with persistent asthma that was utilizing electronic patient reported outcomes (ePRO) the sponsor planned a sophisticated implementation that would prevent inaccuracies and data collection failures in the field. METHODS: Subjects were provided with an electronic patient diary (eDiary), and a PEF meter equipped with wireless technology that automatically sends data to the eDiary. Subjects were also given the option to transcribe PEF readings manually into the eDiary, without the use of the wireless transfer feature. RESULTS: 110 subjects at 23 investigator sites throughout Europe were expected to have reported 12,195 individual PEF score measurements. 86.5% of the total expected scores were captured electronically and transferred automatically by the eSense PiKo, 12.5% of the PEF scores were manually transcribed into the eDiary, and 1.0% were skipped. CONCLUSIONS: By utilizing an ePRO system with a wirelessly integrated PEF meter, and a manual data entry mode for backup purposes, the sponsor captured a significantly higher quantity of verified data as compared to older methods. Frequent voluntary use of the eSense PiKo device, supported by a detailed process flow chart, has enabled the capture of timely and verified PEF data for safety and efficacy evaluations. Funding: AstraZeneca

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Bronchial Reactivity in Adolescents with Mild Allergic Asthma V. Tsybulkina1, O. Skorohodkina1, A. Luntsov1, N. Tsybulkin2, L. M. DuBuske3; 1Kazan State Medical University, Kazan, RUSSIAN FEDERATION, 2Kazan State Medical Academy, Kazan, RUSSIAN FEDERATION, 3Immunology Research Institute of New England, Gardner, MA. RATIONALE: Allergic asthma (AA) in adolescents is often mild. Bronchoprovocation tests (BPT) can verify the diagnosis in equivocal cases. Concomitant evaluation using different non-specific BPT may enhance the diagnosis of mild AA. METHODS: Male teenage patients with intermittent or mild persistent AA were assessed. Clinical exams and spirometry were normal. Skin tests with environmental allergens were positive in all patients. Allergenspecific BPT were positive in 15 patients (Group I) but negative in 22 patients (Group II). Further assessments included total IgE levels and nonspecific standard BPTs: 1) treadmill exercise, 2) histamine inhalation, and 3) hypertonic saline inhalation. The diagnostic FEV1 threshold for exercise BPT was 15% reduction, for histamine and hypertonic saline BPT was 20% reduction, with PC20 measurement. RESULTS: In Group I, 66.7% were positive upon BPT with exercise, 100% upon BPT with histamine and 53.4% upon BPT with hypertonic saline versus 45.5%, 81.8% and 18.2% respectively in Group II. The PC20 for BPT differed between Group I versus Group II with histamine PC20: 1.78 6 1.09 mg/ml versus 5.17 6 2.75 mg/ml (p < 0.05); and hypertonic saline PC20: 8.25 6 2.92 mg/ml versus 12.25 6 3.09 mg/ml (p > 0.05). Total IgE levels were similar in Group I (169.90 6 43.90 U/ml) and in Group II (134.20 6 28.20 U/ml). CONCLUSIONS: Adolescent AA patients having positive allergenspecific BPT react more frequently and at a lower reaction thresholds to all assessed non-specific BPT, with a near 3-fold lower histamine PC20 in this allergic asthma cohort. Specific and non-specific BPT may assist in diagnosis of mild adolescent AA reflecting both allergen specific and non-specific disease triggers.