A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis (NCT02440009) | Clinical Trial Compass
CompletedPhase 2/3
A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis
India191 participantsStarted 2014-05
Plain-language summary
The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:
* asthma
* immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels \>0.35 kUA/L
* elevated total IgE levels \>1000 IU/mL and, two of the following features:
* presence of precipitating antibodies against A.fumigatus in serum
* fixed or transient radiographic pulmonary opacities
* total eosinophil count \>1000/µL
* bronchiectasis on HRCT chest
Exclusion Criteria:
* Intake of systemic glucocorticoids for more than three weeks in the preceding six months
* Exposure to azoles in the last six months
* Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others
* Patient on immunosuppressive drugs
* Pregnancy
* Enrollment in another trial of ABPA
* Failure to provide informed consent
What they're measuring
1
Relapse rates
Timeframe: 12 months
2
Glucocorticoid-dependent ABPA
Timeframe: 24 months
Trial details
NCT IDNCT02440009
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh