NCT06654934Not yet recruitingPhase 4
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis
Prednisolone for 12 Versus 6 Months to Treat Pulmonary Sarcoidosis: a Randomized Trial
Source: ClinicalTrials.gov · Last updated 23 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- Nov 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- Tuberculosis
- NCT number
- NCT06654934
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From Nov 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received glucocorticoids (prednisolone equivalent \>15 mg/day) for more than three weeks in the preceding year
Other illness
- Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)
- Having absolute contraindication for prednisone (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)
Other
- Pregnant or lactating women
- Unwilling to participate in the study
Who the study is looking for
- Age between 18 and 65 years
- Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung/mediastinal lymph nodes
- Diagnosis of sarcoidosis made on cytological or histological samples
- Having significant symptoms requiring immunosuppressive treatment and/or having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrapulmonary manifestation of the disease requiring treatment with low-medium dose glucocorticoids
- Onset of symptoms within two years of study entry
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Post Graduate Institute of Medical Education and Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.