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Safety of formoterol Turbuhaler® at cumulative dose of 90 µg in patients with acute bronchial obstruction

¹ Dept of Internal Medicine and Allergology, Wroclaw University of Medicine, Poland, ² Korányi National Institute for Tuberculosis and Pulmonology, Budapest, Hungary, ³ AstraZeneca R&D Lund, Lund, Sweden

CORRESPONDENCE: J. Malolepszy, Dept of Internal Medicine and Allergology, Wroclaw University of Medicine, Ul. Traugutta 57/59, PL-50-417, Wroclaw, Poland. Fax: 48 713442164

Keywords: Acute bronchoconstriction, high-dose formoterol, Turbuhaler®

Received: June 12, 2001
Accepted July 3, 2001

This study was supported by AstraZeneca R&D, Lund, Sweden.

This study compared the safety of formoterol (Oxis® Turbuhaler®; 90 µg delivered dose; 120 µg metered dose) with terbutaline (Bricanyl® Turbuhaler®; 10 mg), in patients with acute bronchoconstriction.

Forty-eight patients (31 females) with a mean age of 45 yrs, were randomized into two parallel groups (double-blind design). Mean baseline forced expiratory volume in one second (FEV₁) was 0.98 L (33% of predicted normal). Study drugs were administered on six occasions during 3 h (formoterol 4.5 µg or terbutaline 0.5 mg·inhalation^–1, 20 inhalations). Patients received intravenous prednisolone after 1.5 h and oxygen during the first 3 h. Pulse rate, serum potassium, 12-lead electrocardiogram (ECG), Holter ECG, arterial blood gases and FEV₁ were assessed during 12 h after the first dose.

Four patients (one formoterol, three terbutaline) discontinued. The 12-h mean values of serum potassium decreased from 4.02 to 3.89 mmol·L^–1 for formoterol and from 4.22 to 3.76 mmol·L^–1 for terbutaline. Mean 12-h pulse rate was significantly (p<0.01) higher in the terbutaline group (101.7 beats per minute (bpm)) than in the formoterol group (93.5 bpm). No individual patient value was considered clinically important or alarming. FEV₁ improved in both groups but with no statistically significant difference between treatments.

Oxis® Turbuhaler® (90 µg) was at least as safe and well tolerated as terbutaline (110 mg) in patients with acute bronchoconstriction.