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Table 1 Patient demographics, baseline and study characteristics

From: Efficacy and safety profile of mucolytic/antioxidant agents in chronic obstructive pulmonary disease: a comparative analysis across erdosteine, carbocysteine, and N-acetylcysteine

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
  1. AECOPD acute exacerbation of COPD, COPD chronic obstructive pulmonary disease, FEV1: forced expiratory volume in 1 s; NA: not available