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Open Access 01-12-2020 | COPD Exacerbation | Study protocol

High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China

Authors: Heshen Tian, Yumin Zhou, Longhui Tang, Fan Wu, Zhishan Deng, Bijia Lin, Peiyu Huang, Shaodan Wei, Dongxing Zhao, Jingping Zheng, Nanshan Zhong, Pixin Ran

Published in: Trials | Issue 1/2020

Abstract

Introduction

The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD.

Method and analysis

A randomized, double-blinded, placebo-controlled, parallel-group, multicenter clinical trial is evaluating the efficacy and safety of NAC for the long-term treatment of patients with early-stage COPD at 24 centers in China. Subjects aged 40–80 years and recruited by physicians or researchers with special training will be randomized to either NAC 600 mg twice daily group or matching placebo group for 2 years. Measurements will include forced expiratory volume in 1 s (FEV₁), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.

Discussion

Currently, there are no randomized controlled trials with high-dose N-acetylcysteine (600 mg twice daily) for patients with mild-to-moderate COPD (GOLD I–II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-dose N-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management.

Trial registration

Chinese Clinical Trial Registry ChiCTR-IIR-17012604. Registered on 07 September 2017.

Available only for authorised users

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Title: High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China
Authors: Heshen Tian
Yumin Zhou
Longhui Tang
Fan Wu
Zhishan Deng
Bijia Lin
Peiyu Huang
Shaodan Wei
Dongxing Zhao
Jingping Zheng
Nanshan Zhong
Pixin Ran
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: COPD Exacerbation
Spirometry
Acetylcysteine
Chronic Obstructive Lung Disease
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04701-8

At a glance: The STEP trials

Springer Medicine

High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China

Abstract

Introduction

Method and analysis

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Method and analysis

Discussion

Trial registration

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