Steroid Treatment Effect in Pulmonary Sarcoidosis

Steroid Treatment Effect in Pulmonary Sarcoidosis - STEPS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44859

Enrollment

Registered

2013-07-09

Start date

2013-12-19

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Repeated measurements of the FVC and prednisone dose used	—

Secondary

Measure	Time frame
1. Demographic data and clinical status (age, gender, ethnicity, smoking status, co-morbidities, extra thoracic manifestations, date and method of sarcoidosis diagnosis); 2. Patient reported pulmonary complaints objectified in dyspnoea (Medical Research Council (MRC) scale), quality of life (St. George Respiratory Questionaire (SGRQ)), sarcoidosis specific quality of life (KSQ), general health (SF-36) and fatigue scores (Fatigue Assessment Scale (FAS)); 3. Repeated measurements of weight; 4. Extent of pulmonary disease (in-hospital pulmonary function data and radiology data); 5. Laboratory data (ACE, calcium, glucose, sIL2R, creatinine, urine analysis (calcium/creatinine/protein), CRP); 6. Exploratory immunological analysis of lymphocyte subsets (i.e. amount of macrophages, NK-cells, dendritic cells, T-cells, B-cells and cytokines; apoptotic susceptibility towards FasL, IL-2 deprivation and prednisone; expression of activation, differentiation and apoptotic markers; immunosuppressive function of lymphocyte subsets and HLA-type will be examined) .	—

Measure

Time frame

1. Demographic data and clinical status (age, gender, ethnicity, smoking status, co-morbidities, extra thoracic manifestations, date and method of sarcoidosis diagnosis); 2. Patient reported pulmonary complaints objectified in dyspnoea (Medical Research Council (MRC) scale), quality of life (St. George Respiratory Questionaire (SGRQ)), sarcoidosis specific quality of life (KSQ), general health (SF-36) and fatigue scores (Fatigue Assessment Scale (FAS)); 3. Repeated measurements of weight; 4. Extent of pulmonary disease (in-hospital pulmonary function data and radiology data); 5. Laboratory data (ACE, calcium, glucose, sIL2R, creatinine, urine analysis (calcium/creatinine/protein), CRP); 6. Exploratory immunological analysis of lymphocyte subsets (i.e. amount of macrophages, NK-cells, dendritic cells, T-cells, B-cells and cytokines; apoptotic susceptibility towards FasL, IL-2 deprivation and prednisone; expression of activation, differentiation and apoptotic markers; immunosuppressive function of lymphocyte subsets and HLA-type will be examined) .

—

Countries

Netherlands

Outcome results