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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relapse rates

Timeframe: 12 months

Glucocorticoid-dependent ABPA

Timeframe: 24 months

Trial details

NCT IDNCT02440009

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Allergic Bronchopulmonary Aspergillosis trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.