The Occurence of Inflammation and Oxidative Stress in Lung Diseases

February 22, 2017 updated by: Maastricht University Medical Center

The Inflammatory and Antioxidant Status in Pulmonary Sarcoidosis, Idiopathic Pulmonary Fibrosis and COPD: a Potential Role for Antioxidants

Reactive oxygen species (ROS) are suggested to play a pivotal role in ILD. Little is known, however, about the endogenous antioxidant levels in ILD that can offer protection against ROS. It is expected that the high amount of ROS present in ILD will reduce the antioxidant levels. Therefore, antioxidant therapy to strengthen this reduced antioxidant defense might be efficacious in ILD treatment. Since ROS are capable of initiating and mediating inflammation, antioxidant therapy might also mitigate elevated inflammation. A candidate for antioxidant therapy is the flavonoid quercetin that is known for its anti-oxidative and anti-inflammatory capacities.

The aim of the present study is to determine the antioxidant and inflammatory status in ILD, i.e. sarcoidosis and idiopathic pulmonary fibrosis (IPF). Furthermore, to evaluate the possible anti-inflammatory effects of antioxidants, the effect of quercetin will be examined on the ex vivo LPS-induced cytokine production in ILD

Study Overview

Status

Completed

Conditions

Detailed Description

Interstitial lung diseases (ILD) include various chronic lung disorders such as sarcoidosis and idiopathic lung fibrosis (IPF). In the Netherlands the incidence of sarcoidosis is approximately 20-25 per 100.000 inhabitants whereas that of IPF is approximately 1000-1500 new cases each year.

In short, three different stages in the development of ILD can be discerned. Firstly, the lung tissue is damaged. In sarcoidosis this damage is thought to be antigen-driven, multisystemically and leading to the formation of granuloma. Moreover, it is suggested that genetic factors play an important role in the genesis of sarcoidosis. In IPF the exact etiology of this damage is unknown, but it has been speculated to be inflicted by an unidentified stimulus that produces repeated episodes of acute lung injury Secondly, the walls of the air sacs in the lung become inflamed as a reaction to the caused damage. This results in the activation of inflammatory cells like macrophages that cause the expression of pro-inflammatory cytokines, especially interleukin-10 and tumour necrosis factor (TNF)-alpha, in the lungs.

Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs) and the lung becomes stiff, causing an irreversible loss of the tissue's ability to transfer oxygen.

It is well-known that inflammation plays a key-role in the occurrence and progression of ILD, although the long-lasting hypothesis that inflammation alone leads to fibrosis is being questioned at the moment. Conventional treatment of ILD comprises nonspecific anti-inflammatory agents such as glucocorticoids (prednisone) and other immune-suppressing medication such as cyclophosphamide, methotrexate and gamma-interferon. However, all these therapies fail to be completely efficacious, suggesting that inflammation alone is indeed not solely responsible for the occurrence and progression of ILD. Paradoxically, anti-TNF-α agents such as infliximab and thalidomide have recently shown some beneficial effects in sarcoidosis.

A pivotal role for reactive oxygen species (ROS) in all three stages has also been proposed. Various biomarkers of oxidative stress, i.e. exhaled ethane and both 8-isoprostane and oxidized proteins in the bronchoalveolar fluid, are elevated in ILD patients of different clinical stages. However, only little is known about the effect of this elevated oxidative stress on the endogenous antioxidant levels present in ILD. Interestingly, clinical administration of an antioxidant, i.e. N-acetylcysteine (NAC), to IPF patients has recently demonstrated that this slows the deterioration of vital capacity and carbon monoxide diffusing capacity (DLCO) at 12 months. This supports the hypothesis that oxidative stress is involved in ILD and proofs the principle of antioxidant treatment in ILD.

It is well-known that oxidative stress and inflammation are intertwined and that the pro-inflammatory cytokine TNF-alpha is capable of stimulating oxidative stress in various cells and tissues. As a result, the preliminary beneficial effects of anti-TNF-alpha agents combined with the preliminary beneficial effects of antioxidants in ILD may indicate that a new strategy of treatment of ILD should ideally combine the reduction of both the oxidative stress and the inflammation occurring in these diseases.

Recently, much attention has been given to the potential health-beneficial properties of flavonoids, natural occurring polyphenolic compounds, and to quercetin, the most commonly occurring flavonoid, in particular. Quercetin is known to be a powerful antioxidant and to possess some anti-inflammatory effects. It is therefore tempting to speculate that quercetin could exert positive effects in ILD.

Since the anti-oxidative and inflammatory changes in ILD are still not exactly known, the aim of the present study is to determine both the anti-oxidant and the inflammatory status in ILD, i.e. sarcoidosis and fibrosis. Furthermore, the possible anti-inflammatory effect of antioxidants on LPS-induced cytokine production, exemplified with the flavonoid quercetin, will be examined.

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maastricht, Netherlands, 6224 LH
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

lung patients visiting the out-patient clinic of the Academic Hospital Maastricht

Description

Inclusion Criteria:

  • clinical diagnosis of pulmonary sarcoidosis, IPF or COPD
  • no treatment for sarcoidosis
  • last exacerbation not more than 24 hours ago for COPD
  • healthy controls
  • no smoking for sarcoidosis and IPF

Exclusion Criteria:

  • pregnancy
  • use of vitamins or food supplements
  • clinical diagnosis (and treatment) of other diseases
  • symptoms of sarcoidosis in other organs besides the lung

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
sarcoidosis
21 onset patients, non-treated
IPF
15 IPF patients, partially treated
COPD
15 COPD patients within 24 hours after their last exacerbation
controls
25 healthy controls, matched for age and gender

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Chair: Aalt Bast, PhD, Maastricht University
  • Principal Investigator: Agnes W Boots, PhD, Maastricht University
  • Study Director: Guido R Haenen, PhD, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • MEC 03-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Search Similar Trials