Nebulized budesonide suspension in acute severe exacerbation of COPD. Randomized controlled trial
Abstract
The randomized placebo-controlled single-hospital centre study assessed the efficacy and safety of nebulized budesonide suspension (BUD; Pulmicort Respules®) in patients with acute exacerbation of COPD. Inclusion criteria were acute exacerbation of COPD (Anthonisen et al., 1987), age elder than 50 yrs, smoking history more than 20 pack yrs, FEV1<50%, no use of systemic steroids in previous 30 days, no need for respiratory support. Forty-two patients with severe COPD (M:F 35:7, mean age 67±7 yrs; FEV1 0.82±0.22 L, pa02 66±9 mm Hg) were randomized to BUD 2 mg bid (n=21) or nebulized placebo (n=21) for 10 days. All patients also received bronchodilators, antibiotics and oxygen if necessary. Treatment with BUD rather than placebo resulted in more rapid improvement in spirometry (AFEV1 after 2, 7, 10 days: 115, 171 and 257 ml in BUD group vs 53, 112 and 139 ml in placebo group respectively) and oxygenation (Δpa02 after 2, 7, 10 days: 1.8, 2.3 and 5.1 mm Hg in BUD group vs 1.2, 2.4 and 2.6 mm Hg in placebo group respectively). Dyspnea score also improved more rapidly in patients received BUD (the 2nd day: p<0.05). The incidence of adverse events was similar between the groups. Hospital readmission rate during 8 weeks after the study therapy was significantly lower in the BUD group (22% vs 50%, p<0.05). Nebulized budesonide suspension is an effective and safe adjunct to the usual treatment of acute exacerbation of COPD.
About the Authors
S. N. Avdeev
НИИ пульмонологии Минздрава РФ
Russian Federation
Russian Federation
O. A. Soutochnikova
НИИ пульмонологии Минздрава РФ
Russian Federation
Russian Federation
A. S. Belevsky
НИИ пульмонологии Минздрава РФ
Russian Federation
Russian Federation
A. G. Chuchalin
НИИ пульмонологии Минздрава РФ
Russian Federation
Russian Federation
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Review
For citations:
Avdeev S.N., Soutochnikova O.A., Belevsky A.S., Chuchalin A.G. Nebulized budesonide suspension in acute severe exacerbation of COPD. Randomized controlled trial. PULMONOLOGIYA. 2003;(5):81-88. (In Russ.)
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