NCT04227483Active, not recruitingPhase 2/3
Deflazacort Vs. Prednisolone in Acute-stage ABPA
A Randomized Controlled Trial of Deflazacort Vs. Prednisolone in Acute-stage Allergic Bronchopulmonary Aspergillosis
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
Oral glucocorticoids are currently the treatment of choice for allergic bronchopulmonary aspergillosis (ABPA). They not only suppress the immune hyperfunction but are also anti-inflammatory. Unfortunately, numerous toxicities and adverse effects have been attributed to glucocorticoids related to both the average dose and cumulative duration of use. Deflazacort is a oxazoline steroid with demonstrated anti-inflammatory and immunosuppressant effects. The novel structural characteristic of deflazacort is associated with substantial lack of sodium-retaining activity, lower interference with carbohydrate metabolism and calcium metabolism in comparison with older glucocorticoids such as prednisolone. The investigators hypothesize that the occurrence of side-effects, primarily weight gain will be lower with deflazacort. In this study, the investigators will compare the safety and efficacy of deflazacort in the treatment of acute-stage ABPA complicating asthma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 10 Jan 2020
- Start date
- 15 Jan 2020
- Primary completion date
- Jul 2025
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- Asthma
- NCT number
- NCT04227483
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 150
- From 15 Jan 2020 to the primary completion date, Jul 2025
- 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
- Taken any prior treatment for ABPA (systemic glucocorticoids, antifungal drugs)
Other illness
- Failure to give informed consent
- Any of the following comorbidity: diabetes mellitus, glaucoma, chronic liver disease and chronic kidney disease
Other
- Enrollment in another trial of ABPA
- Pregnancy
Who the study is looking for
- Patients aged 18-65 years will be included in the study if they meet the modified ISHAM-ABPA working group criteria defined by the presence of all the following three criteria:
- Asthma
- A.fumigatus-specific IgE levels \> 0.35 kUA/L
- Elevated serum total IgE levels \> 1000 IU/mL; and two of the following criteria:
- Presence of elevated A fumigatus-specific IgG \>27 mgA/L;
- Radiographic pulmonary opacities consistent with ABPA
- Peripheral blood eosinophil count \>500/µL.
Age in the registry: 18 years to 65 years · 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 |
|---|---|---|---|
| Chest Clinic, Dept. of Pulmonary Medicine Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.