Chronic Pulmonary AspergillosisGLITZNCT05444946
Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome
A study testing Prednisone tablet and Itraconazole and Oral itraconazole in people with Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Chronic Pulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis
- What is being tested?
- Prednisone tablet and Itraconazole and Oral itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Jun 2022to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects fulfil criteria for ABPA and CPA as below.
- The criteria for CPA would include the presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG >27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions) and, (iv) exclusion of other pulmonary disorders with similar presentation.
- The diagnosis of ABPA will be made based on the presence of all the following: (a) A.fumigatus specific IgE >0.35 kUA/L; (b) total IgE ≥500 IU/mL; (c) eosinophil count ≥500 cells/µL); (d) A.fumigatus IgG>27 mgA/L.
Who cannot join
- failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) >10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake of antifungal triazoles for >3 weeks in the preceding three months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); and, (vi) pregnancy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 1 recruiting
- Recruiting
Chest clinic
Chandigarh, Chandigarh, 160012
Inderpaul S Sehgal, MD,DM, +91-172275 ext. 6823, inderpgi@outlook.com
- Active, not recruiting
Chest clinic, PGIMER
Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
Read the detailed description
Aspergillus causes a variety of pulmonary disorders depending on the host immunity. In immunocompetent hosts, it can cause allergic diseases, the prototype being allergic bronchopulmonary aspergillosis (ABPA). In immunosuppressed host, it causes life-threatening invasive disease. Chronic pulmonary aspergillosis (CPA) represents chronic Aspergillus infection of the pulmonary parenchyma in subjects with normal or slightly suppressed immunity, and generally an underlying structural lung disease (previously treated pulmonary tuberculosis, chronic obstructive pulmonary disease, sarcoidosis, diffuse parenchymal lung disease and others). The diagnosis of CPA is based on the presence of clinical symptoms (low-grade fever, weight loss, malaise, chronic cough, recurrent hemoptysis and others), radiological features (combination of one or more cavities and presence of fungal ball or fibrosis, pericavitary infiltrates, consolidation, nodules and pleural thickening) and the demonstration of either direct (growth of Aspergillus on sputum or bronchoalveolar lavage fluid [BALF] culture) or indirect (elevated serum or BALF galactomannan index or A.fumigatus-specific IgG or precipitin in serum) evidence of Aspergillus infection. Primarily seen in patients with asthma and cystic fibrosis, the diagnosis of ABPA is currently made on the combination of clinical (low grade fever, hemoptysis and others), radiological (bronchiectasis, mucus impaction, centrilobular nodules and others) and immunological (A.fumigatus-specific IgE and IgG, total IgE, and elevated eosinophils) findings.
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. For example, A.fumigatus-specific IgG and Aspergillus precipitins are used both in diagnosing ABPA and CPA.(10) The culture of respiratory tract secretions can demonstrate the growth of Aspergillus in both these disorders. Also, ABPA is a predisposing condition for developing CPA and it is likely that both ABPA and CPA may coexist. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While CPA is primarily due to dysfunction of Th-1 immunity, ABPA represents an inflammatory response due to Th-2 hyper response. Thus, it is possible that subjects with ABPA-CPA overlap could have components of both heightened inflammatory response and local immune dysfunction thereby perpetuating structural lung damage. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
- Being tested
- Prednisone tablet and Itraconazole, Oral itraconazole
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone tablet and ItraconazoleDrug
Also called sporanox
Oral prednisolone 0.5 mg/Kg body weight tapered over 4 months and oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. traconazole will be given for 12 months
Oral itraconazoleDrug
Also called sporanox
Oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. Itraconazole will be given for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Steroid itraconazole | Experimental | Combination of oral glucocorticoid (prednisolone 0.5 mg/Kg body weight tapered over 4 months) and itraconazole for 12 months Receives: Drug: Prednisone tablet and Itraconazole |
| Itraconazole | Active comparator | Oral itraconazole for 12 months Receives: Drug: Oral itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favourable response at six months after the randomization
Proportion of subjects with an overall favourable response at six months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease
Measured: 6 months after randomization
Secondary outcomes (5)
Overall favourable response at 12 months after randomization
Proportion of subjects with an overall favourable response at 12 months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease
Measured: 12 months after randomization
frequency of relapses at 18-months after randomization
Relapse: will be defined as persistent worsening of symptoms (for 14 days or more) as measured by VAS and radiological worsening. The subjects will be investigated for other causes of worsening such as bacterial infection or reinfection/reactivation of tuberculosis before labelling the worsening due to relapse of CPA. A relapse will be defined as an event that occurs 3 months after stopping treatment
Measured: 18 months after randomization
adverse events in either arm
Adverse events due to systemic glucocorticoids and oral itraconazole will be assessed at 2 weeks after treatment initiation and then at 3 months interval till treatment completion
Measured: 12 months after randomization
Serum total IgE response to treatment
proportion of subjects with 25% reduction in serum IgE at 6 weeks after treatment initiation
Measured: 6 weeks after treatment initiation
Serum total IgE during relapse
Proportion of subjects with 50% increase in serum IgE during relapse
Measured: 18 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jun 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects with CPA-ABPA overlap will be randomized to receive either a combination of systemic steroids and oral itraconazole or oral itraconazole alone
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444946
- Sponsor's protocol ID
- INT/IEC/2021/SPL-749
- Acronym
- GLITZ
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared on email to the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome
- ClinicalTrials.gov ID
- NCT05444946
- Acronym / sponsor ID
- GLITZ / INT/IEC/2021/SPL-749
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
Detailed description
Aspergillus causes a variety of pulmonary disorders depending on the host immunity. In immunocompetent hosts, it can cause allergic diseases, the prototype being allergic bronchopulmonary aspergillosis (ABPA). In immunosuppressed host, it causes life-threatening invasive disease. Chronic pulmonary aspergillosis (CPA) represents chronic Aspergillus infection of the pulmonary parenchyma in subjects with normal or slightly suppressed immunity, and generally an underlying structural lung disease (previously treated pulmonary tuberculosis, chronic obstructive pulmonary disease, sarcoidosis, diffuse parenchymal lung disease and others). The diagnosis of CPA is based on the presence of clinical symptoms (low-grade fever, weight loss, malaise, chronic cough, recurrent hemoptysis and others), radiological features (combination of one or more cavities and presence of fungal ball or fibrosis, pericavitary infiltrates, consolidation, nodules and pleural thickening) and the demonstration of either direct (growth of Aspergillus on sputum or bronchoalveolar lavage fluid [BALF] culture) or indirect (elevated serum or BALF galactomannan index or A.fumigatus-specific IgG or precipitin in serum) evidence of Aspergillus infection. Primarily seen in patients with asthma and cystic fibrosis, the diagnosis of ABPA is currently made on the combination of clinical (low grade fever, hemoptysis and others), radiological (bronchiectasis, mucus impaction, centrilobular nodules and others) and immunological (A.fumigatus-specific IgE and IgG, total IgE, and elevated eosinophils) findings.
While ABPA and CPA represent two distinct manifestations of Aspergillus-related lung disease, there is an overlap of investigations that are currently used for the diagnosis of these entities. For example, A.fumigatus-specific IgG and Aspergillus precipitins are used both in diagnosing ABPA and CPA.(10) The culture of respiratory tract secretions can demonstrate the growth of Aspergillus in both these disorders. Also, ABPA is a predisposing condition for developing CPA and it is likely that both ABPA and CPA may coexist. In a previous study, the authors have demonstrated that 22% of subjects with CPA fulfilled the obligatory criteria for ABPA. While CPA is primarily due to dysfunction of Th-1 immunity, ABPA represents an inflammatory response due to Th-2 hyper response. Thus, it is possible that subjects with ABPA-CPA overlap could have components of both heightened inflammatory response and local immune dysfunction thereby perpetuating structural lung damage. While the preferable therapy in patients with ABPA is systemic glucocorticoids, the primary therapy in CPA is oral triazoles. However, a different management protocol in the "overlap group" with low doses of glucocorticoids and triazoles, needs to be systematically explored. In this study the investigators intend to compare the clinical outcomes in subjects with ABPA-CPA overlap treated either with oral azoles or a combination of systemic glucocorticoids and oral azoles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects with CPA-ABPA overlap will be randomized to receive either a combination of systemic steroids and oral itraconazole or oral itraconazole alone
| Arm | Type | Receives |
|---|---|---|
| Steroid itraconazole | Experimental | Drug: Prednisone tablet and ItraconazoleCombination of oral glucocorticoid (prednisolone 0.5 mg/Kg body weight tapered over 4 months) and itraconazole for 12 months |
| Itraconazole | Active comparator | Drug: Oral itraconazoleOral itraconazole for 12 months |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects fulfil criteria for ABPA and CPA as below.
- The criteria for CPA would include the presence of all the following: (i) one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months; (ii) slowly progressive or persistent findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax; (iii) immunological (A.fumigatus-specific IgG >27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions) and, (iv) exclusion of other pulmonary disorders with similar presentation.
- The diagnosis of ABPA will be made based on the presence of all the following: (a) A.fumigatus specific IgE >0.35 kUA/L; (b) total IgE ≥500 IU/mL; (c) eosinophil count ≥500 cells/µL); (d) A.fumigatus IgG>27 mgA/L.
Key exclusion criteria (1 listed)
- failure to provide informed consent; (ii) patients on immunosuppressive drugs, intake of prednisolone (or equivalent) >10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome; (iii) intake of antifungal triazoles for >3 weeks in the preceding three months; (iv) subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT); (v) subjects with others forms of pulmonary aspergillosis (subacute and acute invasive aspergillosis); and, (vi) pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone tablet and ItraconazoleAlso: sporanoxOral prednisolone 0.5 mg/Kg body weight tapered over 4 months and oral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. traconazole will be given for 12 months | Drug | Steroid itraconazole |
| Oral itraconazoleAlso: sporanoxOral itraconazole (400 mg/day). The dose of itraconazole will be adjusted according to therapeutic drug monitoring to achieve a serum trough level of 0.5 microgram/mL. Itraconazole will be given for 12 months | Drug | Itraconazole |
Primary outcome
Favourable response at six months after the randomization
Time frame: 6 months after randomization
Proportion of subjects with an overall favourable response at six months after the randomization. The overall response will be categorized as favourable: improved or stable clinical response with radiologically improved or stable disease
5 secondary outcomes
Overall favourable response at 12 months after randomization
Time frame: 12 months after randomization
frequency of relapses at 18-months after randomization
Time frame: 18 months after randomization
adverse events in either arm
Time frame: 12 months after randomization
Serum total IgE response to treatment
Time frame: 6 weeks after treatment initiation
Serum total IgE during relapse
Time frame: 18 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided. IPD will be shared on email to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone tablet and Itraconazole and Oral itraconazole in people with Chronic Pulmonary Aspergillosis and Allergic Bronchopulmonary Aspergillosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inderpaul S Sehgal, MD, DM (91-172275 ext. 6823, inderpgi@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favourable response at six months after the randomization (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.