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Formoterol as needed with or without budesonide in patients with intermittent asthma and raised NO levels in exhaled air: a SOMA study

¹ Skin and Allergy Hospital, Helsinki University Central Hospital, ² AstraZeneca, Helsinki, ⁴ Pikonlinna Hospital, Tampere University Hospital, Tampere, ⁵ Paimio Hospital, Turku University Central Hospital, Turku, Finland., ³ Center for Allergy, University Hospital, Linköping, ⁶ AstraZeneca, Södertälje, and ⁷ SEMECO AB, Lund, Sweden.

CORRESPONDENCE: T. Haahtela, Skin and Allergy Hospital, Helsinki University Central Hospital, FIN-00290 Helsinki, Finland. Fax: 358 947186500. E-mail: tari.haahtela{at}hus.fi

Keywords: Asthma guidelines, budesonide, exhaled nitric oxide, formoterol, mild intermittent asthma, Turbuhaler®

Received: November 2, 2005
Accepted May 26, 2006

Patients with mild intermittent asthma sometimes show signs of inflammation, and guidelines suggesting bronchodilator therapy alone as needed may be questioned.

The current study compared as-needed use of a rapid-acting ß₂-agonist with as-needed use of a ß₂-agonist and corticosteroid combination as the only medication in asthma patients with intermittent symptoms. A total of 92 nonsmoking asthma patients (of 187 screened) using only an inhaled ß₂-agonist as needed (28 males, 64 females; mean age 37 yrs; mean forced expiratory volume in one second (FEV₁) 101% predicted, mean reversibility 6.5% pred and fractional exhaled nitric oxide (F_eNO) 20 parts per billion (ppb)) were randomised to treatment with formoterol (Oxis® Turbuhaler®) 4.5 µg as needed (n = 47) or budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5 µg as needed (n = 45) in a double-blind, parallel-group 24-week study.

The primary variable of efficacy was change in F_eNO. Baseline F_eNO was 60 ppb and 59 ppb in the budesonide/formoterol and formoterol groups, respectively. Mean reductions in F_eNO in the budesonide/formoterol and formoterol groups were 18.2 ppb and 2.8 ppb, respectively (95% confidence interval (CI) 7.5–23.5 ppb). The reduction in the budesonide/formoterol group occurred during the first 4 weeks of treatment and remained at this low level. Mean FEV₁ increased by 1.8% pred normal value in the budesonide/formoterol group and decreased by 0.9% pred normal value in the formoterol group (95% CI -4.7– -0.7). In the budesonide/formoterol group, use of 4 inhalations·day^-1 of study medication was seen on 21 treatment days compared with 74 in the formoterol group.

In conclusion, as-needed use of an inhaled corticosteroid together with a rapid-acting bronchodilator may be more beneficial than a ß₂-agonist alone in patients with intermittent asthma and signs of airway inflammation. The long-term benefits are unknown.

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