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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000818235

Enrollment

Registered

2009-09-18

Start date

2010-05-26

Completion date

2011-10-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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 criteria

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

Outcome results