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Intravenous N-acetylcysteine performs well in hospitalised patients 

Presented By
Prof. Alberto Papi, University of Ferrara, Italy
ERS 2022

Intravenous N-acetylcysteine demonstrated mucolytic and expectorant efficacy in hospitalised patients with respiratory diseases and abnormal mucus secretion. The agent outperformed placebo in a large, randomised-controlled study.

N-acetylcysteine is an established mucolytic and anti-oxidant medicine for acute and chronic respiratory conditions [1]. In severely ill patients, intravenous administration of this agent may be the preferred route. However, no large-scale trials have studied the efficacy of intravenous N-acetylcysteine as a mucolytic and expectorant therapy.

To address this gap in the literature, Prof. Alberto Papi (University of Ferrara, Italy) and co-investigators randomised 333 patients with acute respiratory conditions and abnormal mucus secretion 1:1:1 to standard-of-care plus a 7-day course of intravenous N-acetylcysteine (600 mg, twice daily), standard-of-care plus intravenous ambroxol hydrochloride (30 mg, twice daily), or standard-of-care plus placebo. Prof. Papi presented the results of the primary endpoints, which were the change from baseline to day 7 in mean sputum viscosity score and expectoration difficulty score, comparing the N-acetylcysteine arm with the placebo arm [2]. The primary endpoints were measured at 4-point ordinal scales.

The sputum viscosity score had improved significantly more in the N-acetylcysteine arm than in the placebo arm (-1.2 vs -1.0; P<0.001). Similarly, the expectoration difficulty score had dropped with 1.4 points in the N-acetylcysteine arm and with 1.1 points in the placebo arm, significantly favouring the experimental arm (P=0.002). Prof. Papi added that the observed safety profile was in line with the good tolerability of intravenous N-acetylcysteine (600 mg, twice daily) that had been reported in previous smaller studies [3].

“This is the first, large, randomised-controlled trial to demonstrate clinical benefits of intravenous N-acetylcysteine in patients with respiratory diseases and abnormal mucus secretion,” decided Prof. Papi.

  1. Sadowska AM, et al. Int J Chron Obstruct Pulmon Dis. 2006; 1(4): 425–434.
  2. Papi A, et al. Randomized, rater-blinded, controlled study of intravenous (IV) Nacetylcysteine (NAC) in hospitalized adults with respiratory tract disease and abnormal mucus secretion. ALERT 1, RCT714, ERS International Congress 2022, Barcelona, Spain, 4–6 September.
  3. Calverley P, et al. Drug Saf. 2021;44(3):273–290.

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