Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice
The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.
Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and
abnormal tests of expiratory flow that do not change markedly over periods of several months
observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which
medication is the most efficacious in the long-term treatment of COPD. In contrast to
asthma, the efficacy and therefore the precise role of inhaled corticosteroids is less clear
in the treatment of patients with COPD. The same applies to another (much less investigated)
possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine.
N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as
acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed
in family practices, is to determine the 3-year treatment effects and cost-effectiveness of
oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying
the course and progression of COPD.
Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder
inhalation, 500 mcg b.i.d.) are compared with placebo
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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