Pirfenidone plus inhaled N-acetylcysteine for idiopathic pulmonary fibrosis: a randomised trial
Open accessAbstract
Background: A randomised controlled trial in Japan showed that inhaled N-acetylcysteine monotherapy stabilised serial decline in forced vital capacity (FVC) in some patients with early idiopathic pulmonary fibrosis (IPF). However, the efficacy and tolerability of combination therapy with an antifibrotic agent and inhaled N-acetylcysteine are unknown. Methods: This 48-week, randomised, open-label, multicentre phase 3 trial compared the efficacy and tolerability of combination therapy with pirfenidone plus inhaled N-acetylcysteine 352.4 mg twice daily with the results for pirfenidone alone in patients with IPF. The primary end-point was annual rate of decline in FVC. Exploratory efficacy measurements included serial change in diffusing capacity of the lung for carbon monoxide (DLCO) and 6-min walk distance (6MWD), progression-free survival (PFS), incidence of acute exacerbation, and tolerability. Results: 81 patients were randomly assigned in a 1:1 ratio to receive pirfenidone plus inhaled N-acetylcysteine (n=41) or pirfenidone (n=40). The 48-week rate of change in FVC was −300 mL and −123 mL, respectively (difference −178 mL, 95% CI −324–−31 mL; p=0.018). Serial change in DLCO, 6MWD, PFS and incidence of acute exacerbation did not significantly differ between the two groups. The incidence of adverse events (n=19 (55.9%) for pirfenidone plus N-acetylcysteine; n=18 (50%) for pirfenidone alone) was similar between groups. Conclusions: Combination treatment with inhaled N-acetylcysteine and pirfenidone is likely to result in worse outcomes for IPF.
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Trials combining pirfenidone with oral or inhaled acetylcysteine failed to show additional efficacy compared with pirfenidone monotherapy.
“Additional trials with combined pirfenidone paired with both oral and inhaled acetylcysteine failed to show additional efficacy compared to pirfenidone monotherapy [79–81].”
From Emerging pharmacological options in the treatment of idiopathic pulmonary fibrosis (IPF) (2024) · cites this paper as [80]
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- Authors
- Sakamoto, S., Kataoka, K., Kondoh, Y., Kato, M., Okamoto, M., Mukae, H., Bando, M., Suda, T., Yatera, K., Tanino, Y., Kishaba, T., Hattori, N., Taguchi, Y., Saito, T., Nishioka, Y., Kuwano, K., Kishi, K., Inase, N., Sasaki, S., Takizawa, H., Johkoh, T., Sakai, F., & Homma, S.
- Affiliations
- Toho University Omori Medical Center (JP)
- Tosei General Hospital (JP)
- Juntendo University (JP)
- Kurume University (JP)
- Nagasaki University (JP)
- Jichi Medical University (JP)
- Hamamatsu University (JP)
- University of Occupational and Environmental Health Japan (JP)
- Fukushima Medical University (JP)
- Okinawa Prefectural Chubu Hospital (JP)
- Hiroshima University (JP)
- Tenri Hospital (JP)
- Ibarakihigashi National Hospital (JP)
- Tokushima University (JP)
- Jikei University School of Medicine (JP)
- Tokyo Medical and Dental University (JP)
- Juntendo University Urayasu Hospital (JP)
- Kyorin University (JP)
- Kansai Rosai Hospital (JP)
- Saitama International Medical Center (JP)
- Toho University (JP)
- ORCID
- Sakamoto, Susumu
- Kataoka, Kensuke
- Kondoh, Yasuhiro
- Kato, Motoyasu
- Okamoto, Masaki
- Mukae, Hiroshi
- Bando, Masashi
- Suda, Takafumi
- Yatera, Kazuhiro
- Tanino, Yoshinori
- Kishaba, Tomoo
- Hattori, Noboru
- Taguchi, Yoshio
- Nishioka, Yasuhiko
- Kuwano, Kazuyoshi
- Kishi, Kazuma
- Sasaki, Shinichi
- Takizawa, Hajime
- Johkoh, Takeshi
- Sakai, Fumikazu
- Homma, Sakae
- Venue
- European Respiratory Journal
- Publisher
- European Respiratory Society (ERS)
- Published
- 2020-07-23
- Volume
- 57
- Issue
- 1
- Pages
- 2000348
- ISSN
- 0903-1936 (ISSN-L)
- 1399-3003
- OpenAlex
- W3044568991
- Cited by
- 67
- References
- 30
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 28 · 2023: 9 · 2022: 12 · 2021: 7 · 2020: 1
- FWCI
- 4.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- European Respiratory Journal (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Agency for Medical Research and Development (15ek0109064h0002, 16ek0109064h0003)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Pulmonary Hypertension Research and Treatments
- Keywords
- idiopathic pulmonary fibrosis, pirfenidone, combination therapy, antifibrotic agents, forced vital capacity decline, diffusing capacity for carbon monoxide, 6-minute walk distance, progression-free survival, acute exacerbation, adverse events
- MeSH terms
- Acetylcysteine, Anti-Inflammatory Agents, Non-Steroidal, Humans, Japan, Pyridones, Vital Capacity, Treatment Outcome, Idiopathic Pulmonary Fibrosis
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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