Individual Sensitivity for Interstitial Lung Diseases

NCT00741572 | Completed

• 1 other identifier: MEC 08.3.048
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases, including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic disease that includes damage to the lungs in 90% of the patients. Generally, the disease can be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of only the lungs, in which an unknown cause induces a strong inflammation reaction leading to acute lung damage that ultimately results in the formation of scar tissue and stiffness of the lungs. Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental and work-related exposure to various triggers can exert an effect on the course of the diseases. Examples of such triggers include bacteria, organic agents such as pollen and cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is difficult to treat ILD. Consequently, the current guideline is no medication or anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely effective. Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On the one hand, they can induce an inflammatory reaction as we recently demonstrated for various triggers including instillation material and sicila. During such an inflammatory reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between the formation of and the protection against reactive oxygen species (ROS). On the other hand, ILD-inducing triggers may directly cause an increased ROS production that subsequently can evoke an inflammatory reaction. The objective of the current study is to investigate the individual sensitivity for the development of ILD after exposure to various triggers. Main focus will be the differences in the formation of and the protection against ROS as well as the occurring inflammatory reaction after exposure to such triggers. Furthermore, a simple blood test will be developed to study and eventually even predict the individual reaction of subjects to various triggers. Finally, to fully characterize the development of ILD after exposure to various triggers, the exhaled air of patients will be studied in order to identify specific markers of oxidative stress and damage.

Conditions

Interstitial Lung Diseases

Keywords

sarcoidosis; fibrosis; oxidative stress; inflammation; triggers; individual sensitivity

Outcome Measures

Primary Outcomes (2)

• differences in the production of and the protection against ROS

  6 hours

• differences in the occurring inflammatory reaction

  6 hours

Secondary Outcomes (1)

• differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air

  0 hour

Study Arms (2)

1

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study include both men and women, who are 18 years of age or older and diagnosed with ILD using lung biopsy, X ray or BALF (broncho-alveolar lavage fluid) analysis and are either treated for this with anti-inflammatory agents or not. There's no maximum age set for this study since ILD can occur at all ages. Additional criteria are non smoking, no pregnancy or lactation and no use of vitamins or nutritional supplements. The inclusion of both treated and untreated patients enables us to study the effectiveness of anti-inflammatory agents on a larger scale.

You may qualify if:

• ILD diagnosis confirmed by lung biopsy, X ray or BALF analysis

You may not qualify if:

• smoking
• pregnancy or lactation
• use of vitamins or nutritional supplements

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Related Publications (1)

• Fijten RRR, Smolinska A, Drent M, Dallinga JW, Mostard R, Pachen DM, van Schooten FJ, Boots AW. The necessity of external validation in exhaled breath research: a case study of sarcoidosis. J Breath Res. 2017 Nov 29;12(1):016004. doi: 10.1088/1752-7163/aa8409.

  PMID: 28775245 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

The patients will be asked to donate 5L exhaled air and 20 ml blood.

MeSH Terms

Conditions

Lung Diseases, Interstitial; Sarcoidosis; Fibrosis; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aalt Bast, PhD

  Maastricht University

  STUDY CHAIR

• Marjolein Drent, PhD, MD

  Maastricht University Medical Center

  STUDY DIRECTOR

• Agnes W Boots, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 24, 2017

Record last verified: 2009-09

Locations

NL (1)