HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (19) Citing Articles via Google Scholar Google Scholar Articles by Decramer, M. Articles by Ardia, A. Search for Related Content PubMed PubMed Citation Articles by Decramer, M. Articles by Ardia, A.

The Bronchitis Randomized On NAC Cost-Utility Study (BRONCUS): hypothesis and design

¹ Respiratory Division, University Hospital, Katholieke Universiteit Leuven, B-3000, Leuven, Belgium, ² Dept of Pulmonary Diseases, University Medical Centre Nijmegen, the Netherlands, ³ Institute for Medical Technology Assessment, Erasmus University Rotterdam, the Netherlands, ⁴ Institute for Extra andTransmural Health Care, Universiteit Maastricht, the Netherlands, ⁵ Respiratory Division, Ospedale Rasori, Parma, Italy and ⁶ Zambon Group, Bresso-Milano, Italy

CORRESPONDENCE: M. Decramer, Professor of Medicine, University Hospital, Respiratory Division, Herestraat 49, B-3000, Leuven, Belgium. Fax: 32 16346803

Keywords: COPD, cost-utility, decline in FEV₁, N-acetylcysteine, oxidative stress, quality of life

Received: June 29, 2000
Accepted November 20, 2000

Chronic obstructive pulmonary disease (COPD) is an irreversible disorder characterized by airflow obstruction and a progressive decline in forced expiratory volume in one second (FEV₁). At present, no treatment except quitting smoking appears to affect the progression of the disease. Oxidative stress has been implicated in its pathogenesis.

The Bronchitis Randomized on NAC Cost-Utility Study (BRONCUS) is a phase III, randomized, double-blind, placebo-controlled, parallel group, multicentre study designed to assess the effectiveness of the antioxidant agent N-acetylcysteine (NAC) in altering the decline in FEV₁, exacerbation rate, and quality of life in patients with moderate to severe COPD. In addition, cost-utility of the treatment will be estimated. Patients will be followed for 3 yrs and evaluated every 3 months. The necessary sample size to demonstrate an effect on the decline in FEV₁ of 20 mL·yr^–1 was estimated to be 478 patients.

Five hundred and twenty-three patients with moderate to severe COPD were recruited from 10 European countries from June 1, 1997–December 31, 1999. They were 63±8 yrs old and consisted of 243 (46%) current smokers and 280 (54%) exsmokers. Patients had on the average 4.9±1.6 exacerbations during the last 2 yrs. Postbronchodilator FEV₁ averaged 57±9% and the reversibility after 400 µg of Salbutamol averaged 4±4% predicted.

The final results of the trial will be available in about 2 yrs. The study will provide objective data on the effects of N-acetylcysteine on outcome variables in chronic obstructive pulmonary disease.

This article has been cited by other articles:

				I. Rahman Review: Antioxidant therapeutic advances in COPD Therapeutic Advances in Respiratory Disease, December 1, 2008; 2(6): 351 - 374. [Abstract] [PDF]

				D. Stolz, M. Christ-Crain, R. Bingisser, J. Leuppi, D. Miedinger, C. Muller, P. Huber, B. Muller, and M. Tamm Antibiotic Treatment of Exacerbations of COPD: A Randomized, Controlled Trial Comparing Procalcitonin-Guidance With Standard Therapy Chest, January 1, 2007; 131(1): 9 - 19. [Abstract] [Full Text] [PDF]

				I. Rahman and I. M. Adcock Oxidative stress and redox regulation of lung inflammation in COPD. Eur. Respir. J., July 1, 2006; 28(1): 219 - 242. [Abstract] [Full Text] [PDF]

				V L Kinnula Focus on antioxidant enzymes and antioxidant strategies in smoking related airway diseases Thorax, August 1, 2005; 60(8): 693 - 700. [Abstract] [Full Text] [PDF]

				P. J. Barnes and R. A. Stockley COPD: current therapeutic interventions and future approaches Eur. Respir. J., June 1, 2005; 25(6): 1084 - 1106. [Abstract] [Full Text] [PDF]

				M Decramer, R Gosselink, M Rutten-Van Molken, J Buffels, O Van Schayck, P-A Gevenois, R Pellegrino, E Derom, and W De Backer Assessment of progression of COPD: report of a workshop held in Leuven, 11-12 March 2004 Thorax, April 1, 2005; 60(4): 335 - 342. [Abstract] [Full Text] [PDF]

				M Decramer, R Gosselink, P Bartsch, C-G Lofdahl, W Vincken, R Dekhuijzen, J Vestbo, R Pauwels, R Naeije, and T Troosters Effect of treatments on the progression of COPD: report of a workshop held in Leuven, 11-12 March 2004 Thorax, April 1, 2005; 60(4): 343 - 349. [Abstract] [Full Text] [PDF]

				K. M. Beeh, J. Beier, N. Koppenhoefer, and R. Buhl Increased Glutathione Disulfide and Nitrosothiols in Sputum Supernatant of Patients With Stable COPD Chest, October 1, 2004; 126(4): 1116 - 1122. [Abstract] [Full Text] [PDF]

				P.N.R. Dekhuijzen Antioxidant properties of N-acetylcysteine: their relevance in relation to chronic obstructive pulmonary disease Eur. Respir. J., April 1, 2004; 23(4): 629 - 636. [Abstract] [Full Text] [PDF]

				C.M.J.M. Gerrits, R.M.C. Herings, H.G.M. Leufkens, and J-W.J. Lammers N-acetylcysteine reduces the risk of re-hospitalisation among patients with chronic obstructive pulmonary disease Eur. Respir. J., May 1, 2003; 21(5): 795 - 798. [Abstract] [Full Text] [PDF]