476 Troleandomycin (TAO) therapy in severe steroid requiring asthma: Effects on bone metabolism

258

J ALLERGY

Abstracts

473

EVALUATION OF PWIROLMT, A ~f34 MNBROWHODILA’IOR AWI’IALLERGY MEDICATION. MR PATIENTS WITH ASTHMA. HA Orgel, JP Kq IL Bernstein, CW Biernban, JT Li, SC Sikel, RB Spxqenberg, DC Tinkelman Pemirolast (PEM) is a new oral antiallerqy medication that is being evaluated for thetl&apy of asthma. In this multicenter, double-blind study, patients with mild reversible airway obstruction (FEV 765% with >15% increase in FF,Vl after albuterol I- 80 mcg by MD11 and requiring daily bronchodilator therapy were candanized to receive PEM 50 or 2% or placebo bid for 6 wks. Also, patients were required to denrxstrate a decrease in FEV > 20% following methacholine challenge: met d- choline challenge was repeated at the end of the study. During the srudy, patients recorded symptoms, pm albuterol MD1 use and PEFR. Ninety-five patients completed the study. Patients in all treatment groups had slight improvement the first 2 weeks of therapy. Subsequentlyr patients receiving placebo and PE%I 25nq bid did not differ: symptoms remained near baseline scores or increased. By contrast, those receiving PEM 5Cmg demonstrated lower symptom scores than placebo patients (p=O.O2) and used less albuterol (p=O.O5). However, there were no significant changes in methacholine sensitivity or in pulmonary functions. Ihe improvemnt in asthma was gradual and consistent with the proposed mechanism of action of PEM as an inhibitor of mediator release with secondary reduction of inflanmatory processes. There were few adverse events. We conclude that PEM 5&q bid showed sufficient therapeutic activity In patients with mild asthma to warrant further evaluation.

474

A 0%YBB[ EVALUATION OP SALMBTEBOL, A NBU LONGACTING BEfA -ADRIO(BRGIC ABROSOL, FOR ASTMA TBEBAPY. JP%dmu. CU Biernen. BA BroWy. DM Coocbetto. DD D-8, SE Justus. R Liddle, !?A Orxel. DG Tlnkslnn. A v@iAS. Salwterol (SUL) has dmnstratsd long-lasting bronchodllatation in single dose studies in asthmatic patients. In this alticanter, double-blind, parallel-group, placebo-controlled dose-ranging study of inhaled SML by MDI, 160 mild to moderate asthmatics (PEP ~40-801 of predicted; mean age, 26 prs) wer Q randomized to receive SHL 12.5, 25, 50, lOO& or plaoebo (PL) q12hrs for 7 days. Albuterol l01 pm was usad as back-up medication. Subjective symptom assessmsnt and am/pm PRR were recorded in diaries. Serial 12-hour PFTs were done on days 1 and 8. Number (n) of Detients resoomlinn to treatmat with a >155 l.narBue in PBV DAY 1 DAY 8 ’ snL& 12.5 25 50 100 PL SHLyg 12.5 25 50 100 PL

Dose-related increases in PmR were seen with Sl4L 25, 50 and 100 yg with an overall decrease in diurnal variation. Exacerbations of asthma and use of baok-up albuterol MD1 were more oopY)n in patients receiving placebo. Slight increases in pulse rate and tremor were noted with Sl4L lOOyg, but no other significant. changes were seen in clinical lab values, vital signs or BCGs. Ye conolude that SML ql2hrs by WI over a one we& period produoes broncbodilatation of long duration with no evidence of subsensitivity.

476

CLIN. IMMUNOL JANUARY 1991

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