Table 1 Patient demographics, baseline and study characteristics
Study, authors, year, trial registration, and reference | Study characteristics | Study duration (weeks) | Enrolled patients | Drugs and daily doses | Disease characteristics | AECOPD definition | Patient with AECOPD history (%) | AECOPD in the previous year (rate) | Age (years) | Male (%) | Current smokers (%) | Smoking history (pack-years) | Post-bronchodilator FEV1 (% predicted) | Jadad score |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
RESTORE, Dal Negro et al., 2017, NCT NCT01032304 [6] | Multicentre, double-blind, randomized, placebo-controlled, parallel-group | 52 | 467 | Erdosteine, 600 mg | FEV1 ≥ 30% and ≤ 70% | “A symptomatic worsening beyond normal day-to-day variations and requiring a change in regular medication and/or health care resources utilisation (e.g. increased use of bronchodilators, treatment with antibiotics and/or systemic corticosteroids, visit to an emergency department, hospitalization)” | 100 | 2.3 | 65 | 74 | 29 | > 10 | 52 | 5 |
PANTHEON, Zheng et al., 2014, ChiCTR-TRC-09000460 [7] | Multicentre, double-blind, randomized, placebo-controlled, parallel groups | 52 | 1006 | N-acetylcysteine, 1200 mg | FEV1 ≥ 30% and ≤ 70% | “At least a 2 day persistence of two (type II moderate) or all three (type III, severe) major symptoms (worsening dyspnoea, increase in sputum purulence or volume), or of any one major symptom plus at least one minor symptom (type I, mild) (upper airway infection, unexplained fever, and increased wheezing).” | 100 | 1.8 | 66 | 82 | 18 | 36 | 49 | 4 |
HIACE, Tse et al., 2013, NCT01136239 [8] | Single-centre, double-blind, randomized placebo-controlled, parallel groups | 52 | 120 | N-acetylcysteine, 1200 mg | FEV1: NA | “Two of the following three symptoms: increase in shortness of breath, volume, or purulence of sputum.” | NA | 2 | 71 | 93 | 23 | NA | 60 | 4 |
PEACE, Zheng et al., 2008, UMIN-CRT C000000233 [9] | Multicentre, double-blind, randomized, placebo-controlled, parallel groups | 52 | 707 | Carbocysteine, 1500 mg | FEV1 ≥ 25% and ≤ 79% | “At least 2-day persistence of at least two major symptoms (worsening dyspnoea and an increase in sputum purulence, volume, or both), or of any single major symptom plus more than one minor symptom (upper airway infection, unexplained fever, and increased wheezing).” | 100 | NA | 65 | 79 | 74.5 (ever smokers) | NA | 45 | 5 |
Tatsumi et al., 2007, NA [35] | Multicenter, randomized, parallel groups | 52 | 142 | Carbocysteine, 1500 mg | FEV1 < 80% | “Changes in the following symptoms from their stable condition according to the Anthonisen criteria: dyspnea, sputum purulence, sputum volume, cold, wheeze, cough, fever, and change in respiratory rate or heart rate of 20%.” | 100 | NA | 70 | 92 | NA | NA | < 70 | 1 |
Yasuda et al., 2006, NA [36] | Randomized, double blind, placebo-controlled, parallel groups | 52 | 156 | Carbocysteine, 1500 mg | FEV1 ≥ 30% | “An acute and sustained worsening of COPD symptoms requiring changes to regular treatment, as previously described.” | NA | NA | 73 | 85 | NA | 44 | 62 | 3 |
Moretti et al., 2004, NA [10] | Multicentre, randomized, double-blind, placebo-controlled, parallel groups | 32 | 155 | Erdosteine, 600 mg | FEV1 < 70% | “New episodes of acute disease with muco-purulent or purulent sputum, cough and at least two of the following symptoms: general malaise, fever > 38 °C, breathlessness, difficulty in expectoration and leukocytosis.” | 100 | NA | 68 | 80 | 33 | > 20 | 59 | 3 |