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Steroid Treatment Effect in Pulmonary Sarcoidosis

Completed
Conditions
sarcoidosis
10024967
Registration Number
NL-OMON44859
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients with stage II/III (based on a chest X-ray or equivalent on a CT-scan) sarcoidosis (established using the criteria of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG));
- A FVC * 80% of predicted AND/OR an absolute decline of *10% predicted FVC within 12 months;
- A pulmonary indication for prednisolone treatment (determined by the treating physician and conform current clinical guidelines) ;
- Written informed consent;
- Age > 18.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous immunosuppressive treatment for sarcoidosis (e.g. prednisone, methotrexate (MTX), Infliximab);
- Use of systemic immunosuppressive therapy within the previous 3 months for another disease then sarcoidosis;
- Contra-indication for steroids;
- Other conditions which could influence pulmonary function, such as:
o Concurrent chronic obstructive pulmonary disorder (COPD);
o Concurrent active asthma (according to GINA guidelines);
o Fibrotic lung disease;
o Pregnancy;
o Morbide obesitas (BMI > 30);
- Pulmonary malignancies.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>1. Repeated measurements of the FVC and prednisone dose used</p><br>
Secondary Outcome Measures
NameTimeMethod
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