CompletedPhase 2Phase 3ACTRN12609000818235

Effect of N-acetylcysteine supplementation on oxidation status and alveolar inflammation in people exposed to asbestos: a double-blind randomised clinical trial

A randomised, double blind, placebo-controlled trial to evaluate the safety and efficacy of N-acetylcysteine for reducing lung inflammation and oxidation in subjects exposed to asbestos


Sponsor

University of Western Australia

Enrollment

70 participants

Start Date

May 26, 2010

Study Type

Interventional

Conditions

Summary

Exposure to asbestos can cause diseases of the lung such as asbestosis, mesothelioma and other lung cancers. Many of the changes in the lung following exposure to asbestos fibres are probably caused by ongoing inflammation and oxidation. N-acetylcysteine (NAC) is an anti-inflammatory and antioxidant drug that has been used for many years in patients with other lung disease. The drug seems to have beneficial effects on symptoms in patients with lung disease. Due to its anti-oxidant proerties we hypothesised that NAC would help to prevent oxidant and inflammatory changes in the lungs of people that have been exposed to asbestos. The aim of this study, therefore, is to investigate if NAC can prevent lung inflammation in people who have been exposed to asbestos and are at risk of asbestos related lung disease.


Eligibility

Sex: MalesMin Age: 40 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • Males attending the WA Asbestos Review Program, including former workers of a crocidolite mine and ex-residents from the former crocidolite mining town of Wittenoom

Exclusion Criteria4

  • Current diagnosis of any asbestos related disease
  • Current diagnosis of chronic repspiratory disease, such as asthma or chronic obstructive pulmonary disease
  • Current smokers
  • People taking any of the following drugs; angiotensin-converting enzyme (ACE) inhibitors, cisplatin or doxorubican, nitroglycerin and isosorbide

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Interventions

N-acetylcysteine a) 1800mg/day (2 x 900mg capsules) b) 16 weeks c) oral - effervescent capsule

N-acetylcysteine a) 1800mg/day (2 x 900mg capsules) b) 16 weeks c) oral - effervescent capsule


Locations(1)

WA, Australia

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ACTRN12609000818235