AsthmaNCT06488703
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
An observational study of Asthma, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 107,032 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2024to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll participants who meets the below inclusion/exclusion criteria.
Who may be able to join
- Male or female, aged 18 years or older.
- Prevalent diagnosis of an underlying condition.
- At least two years of pre observation period. The same inclusion criteria apply to the matched control group, excluding the initiation of Systemic (cortico)steroids / systemic glucocorticoids (SCS) treatment.
Who cannot join
- Have a record of defined SCS-related adverse outcome within two years before index date.
- Have a history of breast cancer and / or tamoxifen prescription
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications [PROGRESS Study]
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.
- Conditions
- Asthma
- Keywords
- PROGRESS, Systemic (cortico)steroids / systemic glucocorticoids, Long term OCS side effects, OCS side effects, SCS side effects, Long term SCS side effects, Asthma, Chronic obstructive pulmonary disease (COPD), Rheumatism, Lupus, Vasculitis, Eosinophilic granulomatosis with polyangiitis (EGPA), Chronic rhinosinusitis with nasal polyps (CRSwNP), Crohn's disease, Ulcerative colitis
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Rheumatic Diseases, Vasculitis, Churg-Strauss Syndrome, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with underlying condition (UC) | 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. | |
| Matching control group | Participants with the same UC but without SCS treatment will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vandage GmbH
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488703
- Sponsor's protocol ID
- 222292
- Status last verified
- May 2026
- First submitted
- 28 Jun 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Individual data sharing
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications [PROGRESS Study]
- ClinicalTrials.gov ID
- NCT06488703
- Acronym / sponsor ID
- 222292
- Conditions
- Asthma
- Keywords
- PROGRESS, Systemic (cortico)steroids / systemic glucocorticoids, Long term OCS side effects, OCS side effects, SCS side effects, Long term SCS side effects, Asthma, Chronic obstructive pulmonary disease (COPD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107,032 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Vandage GmbH
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with underlying condition (UC) | – | –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. |
| Matching control group | – | –Participants with the same UC but without SCS treatment will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll participants who meets the below inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- Male or female, aged 18 years or older.
- Prevalent diagnosis of an underlying condition.
- At least two years of pre observation period. The same inclusion criteria apply to the matched control group, excluding the initiation of Systemic (cortico)steroids / systemic glucocorticoids (SCS) treatment.
Key exclusion criteria (2 listed)
- Have a record of defined SCS-related adverse outcome within two years before index date.
- Have a history of breast cancer and / or tamoxifen prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with specific Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
Time frame: Up to 7 months
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.
Percentage of Participants with any Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
Time frame: Up to 7 months
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.
Percentage of Participants with specific Adverse outcome in participants with UC without exposition of systemic glucocorticoids
Time frame: Up to 7 months
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.
Percentage of Participants with any Adverse outcome in participants with UC without exposition of systemic glucocorticoids
Time frame: Up to 7 months
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.
3 secondary outcomes
Percentage of Participants with specific Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time.
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.
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.
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with specific Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids (time frame: Up to 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.