[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. / Langtidsvirkningen af inhaleret budesonid hos patienter med mild og moderat kronisk obstruktiv lungesygdom. Osterbro lunge studie.
Ugeskr Laeger
; 162(4): 493-7, 2000 Jan 24.
Article
en Da
| MEDLINE
| ID: mdl-10697447
We compared the effect of inhaled budesonide with placebo on decline in lung function and respiratory symptoms in a three-year study of patients with chronic obstructive pulmonary disease (COPD). We used a parallel-group, randomized, double-blind, placebo-controlled design, nested in an ongoing epidemiological survey. Patients were non-asthmatic subjects with a decreased ratio between forced expiratory volume in one second (FEV1) and vital capacity (VC); i.e., FEV1/VC < or = 0.7. All included patients had an FEV1 which was irreversible to both inhaled terbutaline and prednisolone. Two hundred and ninety patients were randomized to receive either budesonide, 1200 mcg. daily for six months followed by 800 mcg. daily for 30 months, or placebo for 36 months. Patients had a mean age of 59 years and their mean FEV1 was 2.37 liters or 86% of predicted. Crude FEV1 declines were 41.8 ml/year in the placebo group and 45.1 ml/year in the budesonide group. Using a regression model in the intention-to-treat population, patients in the placebo group had an FEV1 decline of 49.1 ml/year in contrast to 46.0 ml/year in the budesonide group; the estimated difference 3.1 ml/year (95% confidence interval--12.8-19.0) was statistically insignificant, p = 0.70. No effect of inhaled budesonide was seen on respiratory symptoms or number of exacerbations. These findings question the role of longterm inhaled corticosteroids in the treatment of mild-moderate COPD.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Broncodilatadores
/
Budesonida
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Enfermedades Pulmonares Obstructivas
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
Da
Revista:
Ugeskr Laeger
Año:
2000
Tipo del documento:
Article
Pais de publicación:
Dinamarca