An observational study in Asthma, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by GlaxoSmithKline · Observational
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic conditions associated with chronic inflammatory diseases. Limited data are available about long-term- Systemic (cortico)steroids / systemic glucocorticoids (SCS) related side effects. Oral (cortico)steroids / systemic glucocorticoids (OCS) mediated side effects in e.g., rheumatic diseases are not consistently determined. No sufficient cohort analysis determined systematically possible side effects of SCS in the long-term. This study will close this major gap by delivering data about long-term SCS side effects (risk stratification via SCS dose, treatment duration). Therefore, the primary objective of PROGRESS is to quantify the risk of adverse outcomes among populations with specific underlying conditions (UC) with and without exposition to systemic glucocorticoid therapy in Germany. The secondary objective is to analyze the influence of dosage and time of systemic glucocorticoid therapy exposition on the risk of adverse outcomes among these populations with specific UCs. In general, it is evident that a frequent SCS exposure leads to side effects like diabetes or osteoporosis etc., which have the potential to become a major financial burden to healthcare systems. For this reason, the tertiary objective is to quantify the economic burden associated with the incidence of adverse outcomes related to SCS exposition among populations with specific UCs for the German market. The study design will be a retrospective cohort study (claims data) based on a rolling cohort design using an exact matching approach. Persons with different UCs and with SCS treatment exposition are matched to controls with UC but without SCS treatment. Matching will be performed on a quarterly basis. First patient-in is in 01/2009, last patient-in in 12/2020. The study period covers data from 01/2007 to 12/2022. The study population are adult patients with confirmed diagnosis of Bronchial Asthma, COPD, Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis (EGPA), Chronic rhinosinusitis (CRS), Crohn's disease, or Ulcerative colitis in Germany.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 107,032 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will enroll participants who meets the below inclusion/exclusion criteria.
Exclusion Criteria:
Participants with UCs (Bronchial Asthma, coronary obstructive pulmonary disorder \[COPD\], Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis \[EGPA\], Chronic rhinosinusitis \[CRS\], Crohn's disease, and Ulcerative colitis) with Systemic (cortico)steroids/systemic glucocorticoids (SCS) exposure will be evaluated.
Participants with the same UC but without SCS treatment will be evaluated.
Percentage of Participants with specific Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
Percentage of participants with specific adverse outcome among participants with UC with exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia.
Time frame: Up to 7 months
Percentage of Participants with any Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
Percentage of participants with any adverse outcome among participants with UC with exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia.
Time frame: Up to 7 months
Percentage of Participants with specific Adverse outcome in participants with UC without exposition of systemic glucocorticoids
Percentage of participants with specific adverse outcome among participants with UC without exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia.
Time frame: Up to 7 months
Percentage of Participants with any Adverse outcome in participants with UC without exposition of systemic glucocorticoids
Percentage of participants with any adverse outcome among participants with UC without exposition of systemic glucocorticoids will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia.
Time frame: Up to 7 months
Percentage of Participants with specific Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time.
Percentage of participants with specific adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed. Specific adverse outcomes includes incident diagnosis of Type 2 diabetes mellitus, Malignant neoplasm of bladder, non-Hodgkin lymphoma, Cardio-/cerebrovascular disease, Myocardial infarction, Atrial fibrillation and flutter, Heart failure, Cerebrovascular accident, Dyslipidemia, Hypertension, Obesity / abnormal weight gain, Osteoporosis, Osteoporosis diagnosis with osteoporotic fractures, Glaucoma, Cataract, Peptic ulcer, Acute mental disorder, Sleep disorders, Pneumonia, Musculoskeletal disorders, Sepsis, Cystitis, Gastric ulcer, or Functional dyspepsia.
Time frame: Up to 7 months
Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time.
Percentage of participants with any adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed.
Time frame: Up to 7 months
Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy without exposition related to dosage and time.
Percentage of participants with any adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time will be assessed.
Time frame: Up to 7 months
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline