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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741572
Other study ID # MEC 08.3.048
Secondary ID
Status Completed
Phase N/A
First received August 25, 2008
Last updated February 22, 2017
Start date August 2008
Est. completion date September 2009

Study information

Verified date September 2009
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Netherlands Maastricht University Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary differences in the production of and the protection against ROS 6 hours
Primary differences in the occurring inflammatory reaction 6 hours
Secondary differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air 0 hour
See also
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Active, not recruiting NCT00267800 - Database of Interstitial Lung Diseases N/A
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Recruiting NCT06036719 - Interstitial Lung Disease: A Study From Infancy to Elderly Including Relatives
Completed NCT02549248 - Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology N/A
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