Individual Sensitivity for Interstitial Lung Diseases

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00741572
First received: August 25, 2008
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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
Interstitial Lung Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Individual Sensitivity for Interstitial Lung Diseases

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • differences in the production of and the protection against ROS [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • differences in the occurring inflammatory reaction [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air [ Time Frame: 0 hour ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 100
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741572

Locations
Netherlands
Maastricht University
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. A.W. Boots, Maastricht University
ClinicalTrials.gov Identifier: NCT00741572     History of Changes
Other Study ID Numbers: MEC 08.3.048
Study First Received: August 25, 2008
Last Updated: September 23, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
sarcoidosis
fibrosis
oxidative stress
inflammation
triggers
individual sensitivity

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014