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Individual Sensitivity for Interstitial Lung Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741572
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : February 24, 2017
Information provided by:
Maastricht University Medical Center

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.

Condition or disease
Interstitial Lung Diseases

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individual Sensitivity for Interstitial Lung Diseases
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. differences in the production of and the protection against ROS [ Time Frame: 6 hours ]
  2. differences in the occurring inflammatory reaction [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air [ Time Frame: 0 hour ]

Biospecimen Retention:   Samples With DNA
The patients will be asked to donate 5L exhaled air and 20 ml blood.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741572

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Maastricht University
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
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Study Chair: Aalt Bast, PhD Maastricht University
Study Director: Marjolein Drent, PhD, MD Maastricht University Medical Center
Principal Investigator: Agnes W Boots, PhD Maastricht University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. A.W. Boots, Maastricht University Identifier: NCT00741572    
Other Study ID Numbers: MEC 08.3.048
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: September 2009
Keywords provided by Maastricht University Medical Center:
oxidative stress
individual sensitivity
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Immune System Diseases
Respiratory Tract Diseases