Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in CPA-ABPA Overlap Syndrome

NCT05444946 | Recruiting DMC

• 1 other identifier: INT/IEC/2021/SPL-749
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Chronic Pulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after randomization

Secondary Outcomes (5)

• Overall favourable response at 12 months after randomization

  12 months after randomization

• frequency of relapses at 18-months after randomization

  18 months after randomization

• adverse events in either arm

  12 months after randomization

• Serum total IgE response to treatment

  6 weeks after treatment initiation

• Serum total IgE during relapse

  18 months after randomization

Study Arms (2)

Steroid itraconazole

EXPERIMENTAL

Combination of oral glucocorticoid (prednisolone 0.5 mg/Kg body weight tapered over 4 months) and itraconazole for 12 months

Drug: Prednisone tablet and Itraconazole

Itraconazole

ACTIVE COMPARATOR

Oral itraconazole for 12 months

Drug: Oral itraconazole

Interventions

Prednisone tablet and Itraconazole DRUG

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

Also known as: sporanox

Steroid itraconazole

Oral itraconazole DRUG

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

Also known as: sporanox

Itraconazole

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fulfil criteria for ABPA and CPA as below.
• 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.

You may not qualify if:

• (i) 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Chest clinic, PGIMER

Chandigarh, 160012, India

ACTIVE NOT RECRUITING

Chest clinic

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Prednisone; Itraconazole

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Inderpaul S Sehgal, MD, DM

CONTACT

91-172275; inderpgi@outlook.com

Ritesh Agarwal, MD,DM

CONTACT

91-172275; agarwal.ritesh@outlook.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects with CPA-ABPA overlap will be randomized to receive either a combination of systemic steroids and oral itraconazole or oral itraconazole alone

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 6, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

IN (2)