‘Tablo 1. Basolno Charactaristis of the Study Participants.* Characteristic Age at randomization —yr Male sex — 96 Race or ethnic group— 96 white slack igpanic other Former smoker —96 Bod massindet Mean 210% Age at onset of asthma —yr Use of inhaled short. acting bets-agonst for ssthma =2 times wk 3 ‘Unscheduled healthcare vis for asthma in previous year —% Use of corticosteroids for asthena — 56 (ral corticastaroid in previous year Inhaled conticosteroids Daily use ‘Combination of uicazone and salmeterol (va199) a3 u 528 wi 2 3 100 1s (N= 203) 36 9 1s s9 W216 ” 3 6 100Asthma scores JACQ, 19208 1808 asuL 0742018 762015 MiniaQLa 4712 4702 SF.36 quali of fe score Physical component ‘20 san10 Mental component 49210 soe11 Pulmonary function [No.of participants with measurement 198 203 rev, Prebronchodilator— 9% of predicted value] ras 76216 Postzonchadltor— incase fem peborchodlstr ono nae ve Prebronchodiator—% of predicted value) was are Postyonchodlitor—ssrcrease rom preborhodtr sat eat = No.of participants with measurement 2 2 Mean — mg/ml 2740 sata Pio contraindicated — no total no. (35) 102/198 (52) i720 (58) Table 1 (Continued) Placebo Esomeprazole CCharactoistic (N=199) (N=203) pH monitoring No.of participants with deta ast 153 Positive result—9% a ” sass No.of participants assessed 199 203 No. of symptoms 1s oss Distress score 6040.46 osio47 Conditions ther than asthma — 96+ No.of participants with data 199 203 Gastroesophageal reflux disease 1 10 Eczema 20 10 Sinusitis 43 34 Rhinitis 6 3s Food allergies 2 as Allergies that worsen asthma * ** Plus-minus values are means 2SD. MiniAQLQ denotes Mini Asthma Quali of Life Questionnaire, ASUI Asthma Symptom Uti Index, FEV, forced expiratory volume in] second, FV forced vital capac. GSAS Gastroesophageal Reflx Disease Symptom Assessment scale, JACQ Juniper Asthma Contrel Questionnaire, Cy the concentration of inhaled methacholine causing @ 20% reduction in FEV; and SF-36 Medical Outcomes Study 36-tem Short Form General Health Survey Race or ethnic group was sereported. The body-mass index fs the weight in klograms divided by the square ofthe height in meters. Scores on the JACQ range fom Oto 6, wih lower scores indicating better asthma conta and 0.5 asthe minimal clin ically important diference; scores on the ASUI range from Oto 1, wth higher scores indicating less severe asthma; Scores on the MiniAQLG range from 1 to 7, with higher scores indiating better quality of fe and 0 asthe rial dlimealy important diferonce 4 Scores on the SF-36 range fom 1t0 100, wit higher scores indicating beter qualy off and 5 as the minima clin cally important cifference. ‘ererers Predicted values for FEY, and EV are from Hankinson eta? The numberof symptors on the GSAS ranges fom Oto 15. The distress score ranges fom Oto 3 wth lower numn- bors indicating less ditress. +Ht These conditions were selfreported. Table 2. Serious Adverse Events. Event Esomeprazole Placebo Asthma exacerbation requiring hospitalization 3 4 Hospitalization or emergency departmentvi 6 10 for surgery, trauma, or other acute illness Preumoni 1 ° Death from complications after surgery for 1 ° endobronchial tumor Hospitalization for possible cardiac ischemi ° 2 Pregnancy* Total a v + Pregnancy was considered an adverse event requiring discontinuation because the drug is recommended for use during pregnancy only if clearly needed.“Table 3. Epzode of Poor Asthma Control and Component Events. © variable ‘Asthma episodes, acordng to definition "ht di nt nc se of bets agonists a acteron No. of events ‘No, of events person yt Patents wth = event (%) exacerbation components 230% drop in peck expiratoy ow on ‘eoneecutve days No ofevents No, ofevents/personyr ints with 1 event (6) Urgent care vist No ofeverts (No.of events/preont Pasion with=1 event (8) Pacabo (vais) 2s 2 uw 3 (6-200) as 2 aa SL 8 sxc) 11815) 12/0820) 090615) Esomeprazole "e Pacebot 066 035 “cestroesophagel- Rafuctterectont 093 098 om* inadencerate ratios and P values were estimated wih the use of negate biomil regression models with obust variance estimates. {Bales are forthe trestment elect of esomeprazole 2s compared wth placeda_ EP values are forthe modification ofthe treatment eect by pH-onitoring rests, as estimated by lina rogressin.