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Efficacy of inhaled N‐acetylcysteine monotherapy in patients with early stage idiopathic pulmonary fibrosis
Author(s) -
HOMMA SAKAE,
AZUMA ARATA,
TANIGUCHI HIROYUKI,
OGURA TAKASHI,
MOCHIDUKI YOSHIRO,
SUGIYAMA YUKIHIKO,
NAKATA KOICHIRO,
YOSHIMURA KUNIHIKO,
TAKEUCHI MASAHIRO,
KUDOH SHOJI
Publication year - 2012
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/j.1440-1843.2012.02132.x
Subject(s) - medicine , idiopathic pulmonary fibrosis , vital capacity , clinical endpoint , inhalation , acetylcysteine , diffusing capacity , gastroenterology , clinical trial , anesthesia , lung , lung function , biochemistry , chemistry , antioxidant
Background and objective: Idiopathic pulmonary fibrosis (IPF) is a fatal disorder for which there are currently no specific or effective medical treatments. A multicentre, prospective, randomized, controlled clinical trial was conducted to assess the efficacy of inhaled N‐acetylcysteine (NAC) monotherapy in Japanese patients with early stage IPF. Methods: Eligible patients had well‐defined IPF of mild‐to‐moderate severity, with no desaturation on exercise. Of 100 patients screened, 76 were randomly assigned to an NAC treatment group (group A; n = 38) that received 352.4 mg of NAC by inhalation twice daily or to a control group (group B; n = 38) that received no therapy. The primary endpoint was the change from baseline in forced vital capacity (FVC) at 48 weeks. Results: There were no significant overall differences in the change in FVC between groups A and B. Post hoc exploratory analyses showed that NAC therapy was associated with stability of FVC in (i) a subset of patients with initial FVC <95% of predicted ( n = 49; difference in FVC decline 0.12 L; P = 0.02) and (ii) in patients with initial diffusing capacity of carbon monoxide <55% of predicted ( n = 21; difference in FVC decline 0.17 L; P = 0.009). Conclusions: These findings indicate that NAC monotherapy may have some beneficial effect in patients with early stage IPF. Further trials in more select IPF populations with progressive disease are required to prove the efficacy of inhaled NAC.