- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00741572
Individual Sensitivity for Interstitial Lung Diseases
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Maastricht, Nederländerna
- Maastricht University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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1
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2
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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differences in the production of and the protection against ROS
Tidsram: 6 hours
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6 hours
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differences in the occurring inflammatory reaction
Tidsram: 6 hours
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6 hours
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
differences in the presence of so-called volatile organic compounds (VOCs) in the exhaled air
Tidsram: 0 hour
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0 hour
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Samarbetspartners och utredare
Utredare
- Studiestol: Aalt Bast, PhD, Maastricht University
- Huvudutredare: Agnes W Boots, PhD, Maastricht University
- Studierektor: Marjolein Drent, PhD, MD, Maastricht University Medical Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MEC 08.3.048
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