Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion

source extracted confidence: high 2026-04-09
#humans #acetylcysteine #expectorants #ambroxol #respiration-disorders

Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion

Tang et al., 2023 | Eur Rev Med Pharmacol Sci | Rct

Citation

Tang W, Zhu D, ... Qu J-M. Intravenous N-acetylcysteine in respiratory disease with abnormal mucus secretion. Eur Rev Med Pharmacol Sci. 2023-Jun;27(11):5119-5127. doi:10.26355/eurrev_202306_32628

Abstract

OBJECTIVE: Evidence for the mucolytic and expectorant efficacy of intravenous (IV) N-acetylcysteine (NAC) is limited. This study aimed to evaluate in a large, multicenter, randomized, controlled, subject, and rater-blinded study whether IV NAC is superior to placebo and non-inferior to ambroxol in improving sputum viscosity and expectoration difficulty. PATIENTS AND METHODS: A total of 333 hospitalized subjects from 28 centers in China with respiratory disease (such as acute bronchitis, chronic bronchitis and exacerbations, emphysema, mucoviscidosis, and bronchiectasis) and abnormal mucus secretion were randomly allocated in a 1:1:1 ratio to receive NAC 600 mg, ambroxol hydrochloride 30 mg, or placebo as an IV infusion twice daily for 7 days. Mucolytic and expectorant efficacy was assessed by ordinal categorical 4-point scales and analyzed by stratified and modified Mann-Whitney U statistics. RESULTS: NAC showed consistent and statistically significant superiority to placebo and non-inferiority to ambroxol in change from baseline to day 7 in both sputum viscosity scores [mean (SD) difference 0.24 (0.763), p<0.001 vs. placebo] and expectoration difficulty score [mean (SD) difference 0.29 (0.783), p=0.002 vs. placebo]. Safety findings confirm the good tolerability profile of IV NAC reported from previous small studies, and no new safety concerns were identified. CONCLUSIONS: This is the first large, robust study of the efficacy of IV NAC in respiratory diseases with abnormal mucus secretion. It provides new evidence for IV NAC administration in this indication in clinical situations where the IV route is preferred.

Key Findings

NAC showed consistent and statistically significant superiority to placebo and non-inferiority to ambroxol in change from baseline to day 7 in both sputum viscosity scores [mean (SD) difference 0.24 (0.763), p<0.001 vs. placebo] and expectoration difficulty score [mean (SD) difference 0.29 (0.783), p=0.002 vs. placebo]. Safety findings confirm the good tolerability profile of IV NAC reported from previous small studies, and no new safety concerns were identified.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Acetylcysteine
  • Expectorants
  • Ambroxol
  • Respiration Disorders
  • Mucus
  • Double-Blind Method

Evidence Classification

  • Level: Rct
  • Publication Types: Randomized Controlled Trial, Multicenter Study, Journal Article
  • Vertical: NAC-respiratory

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09