A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

NCT02440009 | Completed Phase 2 DMC

• 1 other identifier: Histo-15-IMEC-313
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Allergic Bronchopulmonary Aspergillosis

Outcome Measures

Primary Outcomes (2)

• Relapse rates

  Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value

  12 months

• Glucocorticoid-dependent ABPA

  If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma

  24 months

Secondary Outcomes (4)

• Proportion of patients with a response rates

  Six weeks

• Percentage decline in IgE

  Six weeks

• Time to first relapse

  Two years

• Treatment-related adverse effects

  Six months

Study Arms (2)

Glucocorticoid group

ACTIVE COMPARATOR

Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma

Drug: Glucocorticoids

Itraconazole plus glucocorticoid group

EXPERIMENTAL

Oral itraconazole 200 mg BD for 6 months AND oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma.

Drug: Itraconazole; Drug: Glucocorticoids

Interventions

Itraconazole DRUG

Oral itraconazole 200 mg BD for 6 months

Also known as: Azole

Itraconazole plus glucocorticoid group

Glucocorticoids DRUG

Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months.

Also known as: Steroid

Glucocorticoid group; Itraconazole plus glucocorticoid group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Chest Clinic, PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Itraconazole; Azoles; Glucocorticoids; Steroids

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)

Triazoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pulmonary Medicine, Principal Investigator

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 31, 2017
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

IN (1)