Table 1 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identifying number | Chinese Clinical Trial Registry: ChiCTR-IIR-17012604 |
Date of registration in primary registry | 07 September 2017 |
Secondary identifying numbers | NA |
Source(s) of monetary or material support | Ministry of Science and Technology, China |
Primary sponsor | The First Affiliated Hospital of Guangzhou Medical University |
Secondary sponsor(s) | The First Affiliated Hospital of Guangzhou Medical University |
Contact for public queries | Pixin Ran, MD, pxran@gzhmu.edu.cn |
Contact for scientific queries | Yumin Zhou, MD, zhouyumin410@126.com |
Public title | Long-term regular treatment of early COPD with Acetylcysteine effervescent tablets: a randomized, double-blind, placebo-controlled multicenter clinical study |
Scientific title | Long-term regular treatment of early COPD with Acetylcysteine effervescent tablets: a randomized, double-blind, placebo-controlled multicenter clinical study |
Countries of recruitment | China |
Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
Intervention(s) | Active comparator: N-acetylcysteine effervescent tablets (1200 mg per day) |
Placebo comparator: microcristallin cellulose (matching tablets containing no active ingredients) | |
Key inclusion and exclusion criteria | Aged 40–80 years old, male or female, community or outpatient |
Has respiratory symptoms (chronic cough, sputum, shortness of breath) and/or chronic obstructive pulmonary exposure risk factors (smoking, occupational exposure, indoor and outdoor air pollution, family history of chronic obstructive pulmonary disease, recurrent respiratory tract infection, low birth weight, and genetic factors, etc.) | |
GOLD stages I–II, COPD: FEV1/FVC < 70% and FEV1 ≥ 50% predicted after 20 min with 400 μg of salbutamol inhalation | |
Study type | Interventional |
Allocation: randomized; intervention model: parallel assignment; masking: double blind | |
Primary purpose: prevention | |
Phase IV | |
Date of first enrolment | September 2017 |
Target sample size | 1000 |
Recruitment status | Recruiting |
Primary outcome(s) | The difference of FEV1 (including trough and peak) at 24 months from baseline and the number of acute exacerbations COPD within 24 months between two groups |
Key secondary outcomes | Annual decline of FEV1, forced vital capacity (FVC) and FEV1/FVC (including trough and peak); duration, interval, and severity of COPD exacerbations |