Source: Annual Congress 2002 - Asthma - Therapy and management -3
Disease area: Airway diseases

Abstract

Introduction: The START study is the first worldwide, randomized, prospective asthma study investigating early intervention with ICS in newly diagnosed asthmatics, including 7165 subjects in 32 countries. This report looks at skin side effects.
Method: The study compares budesonide (Pulmicort® Turbuhaler®), 200 or 400 μg, with placebo. Any asthma treatment could be added on top of the double-blind treatment.
Results: Data from the 3-year double-blind part of the study shows a similar frequency of reports of events that are connected to allergic and/or skin reactions/events between the budesonide and placebo treatment groups. An external dermatological expert examined the Astra Adverse Event Dictionary and selected 223 preferred terms as connectable to skin/allergy symptoms. The sum of the number of reported events by preferred term for these terms was 737 in the budesonide group (N=3630) and 739 in the placebo group (N=3591). The table below summarizes the nine most frequently reported events, plus the number of reports for contact dermatitis and anaphylactoid/hypersensitivity reactions.

Preferred Term	Pulmicort®	placebo	Preferred Term	Pulmicort®	placebo
Urticaria	87 (2.4%)	84 (2.3%)	Skin Disorder	21 (0.6%)	24 (0.7%)
Eczema	95 (2.6%)	75 (2.1%)	Allergy	21 (0.6%)	24 (0.7%)
Allergic Reaction	63 (1.7%)	58 (1.6%)	Stomatitis	12 (0.3%)	20 (0.5%)
Dermatitis	52 (1.4%)	63 (1.7%)	Contact Dermatitis	9 (0.2%)	12 (0.3%)
Rash	52 (1.4%)	63 (1.7%)	Anaphylactoid Reaction	1 (0.02%)	6 (0.2%)
Pruritus	25 (0.7%)	27 (0.7%)	Hypersensitivity Reaction	1 (0.02%)	3 (0.08%)

Conclusion: Generally the incidence of skin side effects was low and there was no apparent difference between the budesonide and the placebo group.

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B. Lindmark, A. Sheffer, A. J. Woolcock, P. Diaz Amor, M. Silverman, F. Radner, W. W. Busse, Y. Z. Chen (Madison, Boston, United States Of America; Camperdown, Australia; Lund, Sweden; Leicester, United Kingdom; Beijing, China). Skin side effect pattern in the START study. On behalf of the START safety committee. Eur Respir J 2002; 20: Suppl. 38, 454

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