A Phase 3 interventional study of Posaconazole Delayed Release Oral Tablet and Itraconazole (ITZ) in Chronic Pulmonary Aspergillosis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Not yet recruiting at 2 sites in India. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 3, Interventional, and Treatment
A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs.
The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
Chronic pulmonary aspergillosis (CPA) is a progressive fungal lung disease associated with substantial morbidity and mortality. India bears one of the largest global burdens of CPA owing to the high prevalence of post-tuberculosis lung disease (PTLD), the principal predisposing condition for CPA in low- and middle-income countries (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060). Despite increasing recognition of CPA as a major public health problem, several critical gaps remain in the optimization of antifungal therapy, particularly with respect to azole selection, pharmacokinetic variability, and the emergence of antifungal resistance during prolonged treatment.
Oral itraconazole remains the recommended first-line therapy for CPA (Expert Rev Anti Infect Ther 2026;1-21; Mycoses 2025;68:e70060; Lancet Infect Dis 2026;26:239-249; Curr Opin Pulm Med 2024;30:156-166; Lancet Infect Dis 2022;22:1052-1061). Our group, in a randomized controlled trial, previously showed that extending itraconazole therapy from 6 to 12 months significantly improves treatment outcomes (Lancet Infect Dis 2022;22:1052-1061). However, itraconazole exhibits considerable inter-individual variability in systemic drug exposure, requires therapeutic drug monitoring, and may fail to achieve adequate systemic exposure in a subset of patients (J Antimicrob Chemother 2014;69:1162-1176). Furthermore, prolonged azole exposure may contribute to the development of antifungal resistance, an emerging challenge with important implications for long-term disease control (Expert Rev Anti Infect Ther 2026;1-21). More recently, we showed that voriconazole was not superior to itraconazole in treating CPA; moreover, it was associated with a higher incidence of adverse events (Lancet Infect Dis 2026;26:239-249).
Posaconazole is an attractive alternative to itraconazole and voriconazole owing to its favourable pharmacokinetic profile, predictable systemic exposure, improved tolerability, and potent activity against Aspergillus species. However, its role as primary therapy for CPA has not been evaluated in a randomized clinical trial (Expert Rev Anti Infect Ther 2026;1-21). In addition, prospective data on the emergence of azole resistance during prolonged therapy and its relationship with treatment outcomes remain limited.
This prospective, randomized, open-label comparative study will evaluate oral itraconazole and oral posaconazole in 220 treatment-naïve patients with CPA, with treatment for 12 months. The study will compare clinical effectiveness and safety of the study drugs.
By integrating clinical, microbiological, and azole exposure data, the proposed study seeks to identify determinants of treatment success and failure, define exposure-response relationships for azole therapy, and characterize the emergence of resistance during prolonged treatment. The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease
134 studies on the registry are indexed under Aspergillosis; 10 are open to participants now.
This study's planned enrollment of 220 is above the median of 47 across 75 interventional studies indexed under Aspergillosis.
Browse Aspergillosis studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Itraconazole suprabioavailable capsule 130 mg twice daily
Drug: Itraconazole (ITZ)
Posaconazole 100 mg sustained release capsule (300 mg once a day)
Drug: Posaconazole Delayed Release Oral Tablet
Posaconazole 300 mg will be given once daily
Itraconazole suprabioavailable will be given 130 mg twice daily
Overall favorable treatment response at 12 months
Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.
Time frame: 12 months
Significant treatment-emergent adverse events
Adverse events requiring discontinuation of study medication
Time frame: 12 months
CPA relapse
Relapse after treatment cessation (assessed at 18 months from randomization)
Time frame: 18 months
Time to first CPA relapse
Time to CPA relapse by survival curve analysis
Time frame: 18 months
Quality of life assessment by SGRQ
Change in St. George's Respiratory Questionnaire (SGRQ) score at 6 and 12 months
Time frame: 12 months
All-cause and CPA-related mortality during follow-up
Any death during study
Time frame: 18 months
Subgroup analyses
Prespecified exploratory subgroup analyses will be performed for unfavourable treatment response and CPA relapse according to: (1) sex (men vs women); (2) baseline serum A. fumigatus-IgG concentration (≥100 vs \<100 mgA/L); (3) presence or absence of a fungal ball on baseline chest CT; (4) number of cavities on baseline chest CT (≥2 vs \<2); (5) extent of disease on baseline chest CT (unilateral vs bilateral); (6) age (≥60 vs \<60 years); and (7) baseline overall VAS symptom score (\>50 vs ≤50 mm).
Time frame: 12 months
Overall favorable treatment response at 6 months
Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.
Time frame: 6 months
Unfavourable treatment response or CPA relapse
Unfavorable response or a CPA relapse anytime during study
Time frame: 18 months
Drug discontinuation rates
Discontinuation rate in either arm
Time frame: 12 months
Comparative adverse event profile of itraconazole and posaconazole
Treatment emergent adverse events in either arm graded according to CTCAE version 5.0.
Time frame: 12 months
QoL life change with treatment
Proportion of patients achieving a clinically meaningful improvement in SGRQ (delta SGRQ ≥7) at 6 and 12 months
Time frame: 12 months
Favorable response in those achieving drug levels
Favorable response in subgroup of patients achieving drug levels in the respective arm
Time frame: 12 months
Imaging features (qualitatively)
Imaging features will be collected repeatedly during follow-up will be summarized at each assessment.
Time frame: 12 months
Change in serum A. fumigatus-IgG
Change in serum A. fumigatus-IgG at 6 and 12 months compared to baseline
Time frame: 12 months
Change in body weight
Absolute and percentage change in body weight at 6 and 12 months compared to baseline weight
Time frame: 12 months
Other longitudinal clinical outcomes
Changes in clinical (VAS symptoms scores (0 to 100 mm, 100 being worse),
Time frame: 12 months
Plan to share: Undecided — IPD will be shared on reasonable request to the PI after all administrative clearances
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Post Graduate Institute of Medical Education and Research, Chandigarh →