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Individual Sensitivity for Interstitial Lung Diseases

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ClinicalTrials.gov Identifier: NCT00741572
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : February 24, 2017
Sponsor:
Information provided by:
Maastricht University Medical Center

Tracking Information
First Submitted Date August 25, 2008
First Posted Date August 26, 2008
Last Update Posted Date February 24, 2017
Study Start Date August 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2008)
  • differences in the production of and the protection against ROS [ Time Frame: 6 hours ]
  • differences in the occurring inflammatory reaction [ Time Frame: 6 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 25, 2008)
differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air [ Time Frame: 0 hour ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Individual Sensitivity for Interstitial Lung Diseases
Official Title Individual Sensitivity for Interstitial Lung Diseases
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The patients will be asked to donate 5L exhaled air and 20 ml blood.
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.

Condition Interstitial Lung Diseases
Intervention Not Provided
Study Groups/Cohorts
  • 1
  • 2
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: August 25, 2008)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00741572
Other Study ID Numbers MEC 08.3.048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. A.W. Boots, Maastricht University
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
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
PRS Account Maastricht University Medical Center
Verification Date September 2009