Effect on HRCT Endpoints to Glucocorticoid in Pulmonary Sarcoidosis
Research type
Research Study
Full title
A Multicenter, Open-Label Study To Estimate The Effect Sizes Of HRCT Endpoints In Response To Glucocorticoid Induction Therapy In Subject With Pulmonary Sarcoidsis
IRAS ID
232671
Contact name
Nazia Chaudhuri
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2017-002001-34
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Sarcoidosis is a disease of unknown cause that can affect many organs in the body, which can include the lung, skin, eyes, heart and nerves. The lung is affected in over 90% of sarcoidosis cases and can cause symptoms of cough and/or breathlessness. The way sarcoidosis develops is complex but principally it is characterised by the abnormal accumulation and activity of cells of the immune system that can cause damage to organs. There are no treatments for sarcoidosis that have been proven in clinical trials however because the immune system is involved in its pathology drugs that suppress the immune system principally corticosteroids are the mainstay of treatment. Monitoring response to these treatments is conventionally based on improvement of symptoms and changes in lung function tests, which can be insensitive at detecting early improvements with treatment, thus patients may be on treatment for longer durations. Corticosteroid treatment however can have side effects and if there were other measures that could detect early changes and improvements then this may inform earlier treatment reduction and minimise the risks of side effects. This is therefore the reason for this study. We are exploring the role of High Resolution Computed Tomography imaging (HRCT- a scan of the lungs) at detecting earlier improvements in response to corticosteroid treatment, compared to the conventional methods doctors use to detect improvements with lung function tests.
HRCT can detect different aspects of lung damage from sarcoidosis which include inflammation, lung scarring and more dynamic changes in lung volumes and may allow a more accurate assessment of the impact of pulmonary sarcoidosis on individual areas of the lung and how these areas respond to treatment. These changes in response to treatments may be more accurate at detecting early and small changes compared to our current practice with lung function testing.REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0005
Date of REC Opinion
19 Jul 2018
REC opinion
Further Information Favourable Opinion