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

Autor: Tari Haahtela, H Ylä-Outinen, Jussi Karjalainen, LP Malmberg, Olof Selroos, T Svahn, T Ekström, K Tamminen, Olle Zetterström
Rok vydání: 2006
Předmět:
Zdroj: The European respiratory journal. 28(4)
ISSN: 0903-1936
Popis: 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 β 2 -agonist with as-needed use of a β 2 -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 β 2 -agonist as needed (28 males, 64 females; mean age 37 yrs; mean forced expiratory volume in one second (FEV 1 ) 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 FEV 1 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 β 2 -agonist alone in patients with intermittent asthma and signs of airway inflammation. The long-term benefits are unknown.
Databáze: OpenAIRE