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YMAI10627 Proof 1..27 All abstracts are strictly embargoed until the date of presentation at the 2014 Annual Meeting. J ALLERGY CLIN IMMUNOL Abstracts AB1 VOLUME 133, NUMBER 2 A Rare Presentation Of Surfactant Deficiency In a Term Neonate Therapeutic Equivalence Of Budesonide/Formoterol (BUD/FM) 1 Dr. Nisha N. Shah, MD1, Dr. Heena Shah, MD2, Dr. Kenneth Paris, 3 Breath-Actuated Inhaler (BAI) Compared With Bud/FM Pressurized MD, MPH3; 1LSU Health Sciences Center New Orleans, New Orleans, Metered-Dose Inhaler (pMDI) In Adults and Adolescents With LA, 2Louisiana State University, New Orleans, LA, 3LSU Health Sciences Moderate To Severe Asthma Center, New Orleans, New Orleans, LA. Kevin R. Murphy, MD1, Rajiv Dhand, MD2, Frank Trudo, MD3,Tom RATIONALE: It is important to consider non infectious, and non allergic Uryniak, MS3, Ajay Aggarwal, MD3; 1Boys Town National Research causes of chronic pulmonary inflammation in a term neonate. We describe Hospital, Boys Town, NE, 2Department of Medicine, University of a rare case of surfactant deficiency in a term neonate. Tennessee Graduate School of Medicine, 3AstraZeneca LP. METHODS: Surfactant protein C gene sequencing done at Johns Hopkins RATIONALE: To assess the therapeutic equivalence of BUD/FM DNA laboratory. 160/4.5mg delivered by BAI versus BUD/FM delivered by pMDI. RESULTS: A 5 week old full term female with a history of failure to METHODS: Adults and adolescents >_12 years of age with asthma and >_3 thrive, formula intolerance, intermittent tachypnea, hypoxia, and leuko- months daily use of inhaled corticosteroids were randomized to receive either cytosis presented to our hospital. The patient was born full term via BUD/FM BAI 2x160/4.5mg bid, BUD/FM pMDI 2x160/4.5mgbid,orBUD Cesarean section without complication. Serial chest radiography showed pMDI 2x160mg bid in this 12-week, double-blind, multi-center, parallel- SATURDAY persistent bilateral lung infiltrates. An extensive workup showed no group study (NCT01360021). Inclusion required prebronchodilator FEV1 _ _ _ underlying cardiac, gastrointestinal, or infectious pathology. After 6 weeks >45–<85% of predicted normal, and reversibility of >12% in FEV1 (ages of hospitalization she continued to have leukocytosis, persistent hypoxia 12–17) or >_12% and 200 mL (ages >_18). Assay sensitivity required confirma- on room air, and poor weight gain on elemental formula. Allergic and tion of BUD/FM pMDI superiority to BUD pMDI. Therapeutic equivalence immunologic workup included negative skin prick testing to cow’s milk, between BUD/FM via pMDI and BAI was assessed by estimating the ratio of undetectable IgE to cow’s milk, normal immunoglobulin levels, and treatment effects (pre- and 60 minutes post-dose FEV1) using multiplicative normal lymphocyte subpopulations. A high resolution CT revealed analysis of covariance and baseline pre-dose FEV1 as a covariate. scattered ground glass opacities concentrated in the lower lobes. Lung RESULTS: Randomized patients (N5214) had a mean age of 42.7 years. biopsy revealed alveolar changes consistent with childhood interstitial The objective of demonstrating assay sensitivity was achieved as post-dose lung disease. Genetic testing ultimately revealed an inherited mutation in FEV1 for BUD/FM pMDI was superior to BUD pMDI (treatment effect the gene coding for surfactant C. ratio 1.10, 95% CI 1.06–1.14; P<.001). Demonstrating therapeutic CONCLUSIONS: A mutational surfactant deficiency can present in the equivalence objectives of BUD/FM BAI and pMDI were met for 60 minute term neonate and lead to the pro-inflammatory cascade causing chronic post-dose FEV1 (treatment effect ratio 1.01; 95% CI .97–1.05; P5.547) lung disease well studied in premature neonates. Childhood interstitial and pre-dose FEV1 (treatment effect ratio 1.03; 95% CI .99–1.08; lung diseases can be missed in the newborn period. Its non specific P5.131). Adverse event profiles were similar. presentation can mimic much more common causes of respiratory distress. CONCLUSIONS: BUD/FM 2x160/4.5mg bid delivered by BAI or pMDI Early intervention with steroid therapy can delay the progression of disease were therapeutically equivalent as shown by pre-dose FEV1 and 60 minute and improve quality of life. post-dose FEV1 treatment effect ratios. No differences in safety profiles were identified across the treatment groups. Relapse Of Severe Asthma Exacerbations After Cessation Of 2 Omalizumab Treatment – Real Life Data Effects of Budesonide/Formoterol (BUD/FM) Deliverd By Pressurized Dr. Izabela R. Kuprys-Lipinska, MD, PhD, Prof. Piotr Kuna, MD, PhD; 4 Metered-Dose Inhaler (pMDI) on Symptoms In African Americans and Dept. of Internal Medicine, Asthma and Allergy, Medical University in Caucasians With Moderate and Severe Asthma With and Without Lodz, Poland. Fixed Airway Obstruction (FAO) RATIONALE: Many clinical and observational studies demonstrated Donald P. Tashkin, MD1,BradleyE.Chipps,MD2, Frank Trudo, MD3; effectiveness of omalizumab (OMA) in the treatment of severe asthma, but 1David Geffen School of Medicine at UCLA, Los Angeles, CA, 2Capital the optimal duration of the therapy remains unknown. Allergy & Respiratory Disease Center, Sacramento, CA, 3AstraZeneca, METHODS: Here we present our clinical experience on OMA cessation Wilmington, DE. in routine practice. Due to new reimbursement criteria OMA therapy was RATIONALE: Effects of BUD/FM and BUD on symptoms in African- interrupted in 11 subjects (6 women/5 men) this year. The mean patients’ American and Caucasian moderate to severe asthma patients with and age is 50.7614.2 yrs, the mean severe asthma duration is 13.566.1 yrs. without FAO. The mean OCS dose (prednisone equivalent) before OMA therapy was METHODS: Two 12-week, double-blind studies randomized patients >_12 _ _ 23612.2 mg/day. Six subjects have near-fatal asthma exacerbations years and prebronchodilator FEV1 >45% and <85% predictedtobid BUD/FM recorded in their medical history. Patients received OMA according to 320/9mg pMDI or BUD 320mg pMDI in A: (2 of 5 arms [NCT00652002]) and the manufacturer recommendation. All had good response to OMA and B: ([NCT00702325] BUD/FM 320/9mgpMDIorBUD360mg dry powder asthma deterioration when doses were missed. The mean time of OMA inhaler [DPI]).FAO determination waspost-albuterol FEV1/FVC atscreening therapy was 67.7611.6 months. <lower limits of normal (LLN; FAO+) or >_LLN (FAO-). Mean change from RESULTS: Ten patients had severe asthma exacerbation within first 5 baseline in asthma control days (ACDs), awakening-free nights (AFNs), and months after OMA withdrawal. The mean time to first exacerbation was symptom score (SS, 05no, 35severe symptoms) and response rates (>_15% 7.462.6 weeks. Since OMA cessation to the time of reassessment the increases in ACDs and AFNs, and >_0.5 decreases in SS) are reported. mean ACQ increased from 2.460.8 to 3.661.2 points, AQLQ RESULTS: Patient groups: A (N5559; 83% Caucasian) and B (N5309; decreased from 4.561to3.161.1 points, OCS dose increased from 100% African American). Mean ACDs increased with BUD/FM vs BUD in 4.1561.2mg/dayto33.3613.1 mg/day, the number of exacerbations FAO+ (A: 16.9% vs 2.2%; B: 20.7% vs 13.0%) and also in FAO-. BUD/FM vs increased form 1.560.8 to 4.861.8/year/patient and the number of BUD improved mean AFNs from baseline in B (FAO+ 17.6% vs 10.3%: FAO- hospitalizations or ICU admissions increased from 0.0960.3 to 17.8% vs 13.6%), not in A. BUD/FM improved mean SS in all populations. 1.561.2/year/patient. In nine patients OMA treatment has already Increased ACDs >_15% and decreased SS >_0.5 were higher with BUD/FM been reintroduced. vs BUD in FAO+ (A: 39.6% vs 11.1%; B: 43.2% vs 35.9%), (A: 18.8% vs CONCLUSIONS: These data indicate, that withdrawal of OMA therapy, 16.7%; B: 40.9 vs 23.1%); similarly in FAO-. BUD/FM AFNs >_15% exceeded after successful long-term therapy, may cause severe asthma exacerbations BUD in B (FAO+: 36.4% vs 25.6%; FAO-: 35.8% vs 30.8%), not in A. in a certain group of patients therefore each decision regarding cessation of CONCLUSIONS: BUD/FM improved symptoms for ACD, AFN, and SS OMA treatment should be undertaken individually after careful weighing vs BUD in African-American and Caucasian asthma patients with and of benefits and risks. without FAO. ABS 5.2.0 DTD YMAI10627_proof 11 January 2014 3:05 pm All abstracts are strictly embargoed until the date of presentation at the 2014 Annual Meeting. AB2 Abstracts J ALLERGY CLIN IMMUNOL SATURDAY FEBRUARY 2014 Long-Term Effectiveness Of Omalizumab Treatment In Thai Severe Effects Of Long-Term Treatment With Budesonide/Formoterol (BUD/ 5 Asthmatic Patients: A Real-Life Experience 7 FM) Delivered By Pressurized Metered-Dose Inhaler (pMDI) On Dr. Orapan Poachanukoon, MD1, Dr. Theerasak Kawamatawong2, Symptoms In African-American and Caucasian Patients With Dr. Atik Saengasapaviriya3, Dr. Chanchai Sittipunt4,Dr.Hiroshi Moderate To Severe Asthma With and Without Fixed Airway Chantaphakul, MD, FAAAAI5, Prof. Kittipong Maneechotesuwan6, Obstruction (FAO) Dr. Pintip Ngamchanyaporn7, Dr. Kunchit Piyavechviratana8,Dr.Apichart Randall Brown, MD, MPH1, Bradley E. Chipps, MD2, Donald P. Khanisap9, Dr. Siwasak Juthong10, Dr. Warangkana Rithirak11, Tashkin, MD3, Frank Trudo, MD4; 1Center for Managing Chronic Dr. Chaicharn Pothirat12, Dr. Watchara Boonsawat13; 1Thammasat University, Disease, University of Michigan School of Public Health, 2Capitol Pathumtani, Thailand, 2Ramathibodi Hospaital, Mahidol University, Taiwan, Allergy and Respiratory Disease Center, 3David Geffen School of 3Phramonkutklao hospital, Thailand, 4Chulalongkorn University, Thailand, Medicine at UCLA, Los Angeles, CA, 4AstraZeneca, Wilmington, DE. 5Chutuchak District, Chulalongkorn University Hospital, Bangkok, Thailand, RATIONALE: To assess the effects of long-term treatment with BUD/FM 6Siriraj Hospital, Mahidol University, Bangkok, Thailand, 7Ramathibodi and BUD on symptoms in moderate to severe African-American and Hospaital, Mahidol University, Thailand, 8Pramongkut Hospital, Sathorn, Caucasian asthma patients with and without FAO.
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