Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis

NCT01321827 | Completed Phase 2 DMC

• 2 other identifiers: IGCSTMS/1398/Res/1838
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of itraconazole monotherapy in patients with ABPA.

Conditions

Allergic Bronchopulmonary Aspergillosis

Keywords

ABPA

Outcome Measures

Primary Outcomes (3)

• Remission rates in the two groups at six weeks and three months

  Remission - if the IgE levels decline by \>=25% and there is clinical improvement with partial/total clearance of chest radiographic lesions after three months of glucocorticoids (if previously present pulmonary opacities)

  6 weeks, 3 months

• Percentage decline in IgE levels at six weeks and three months

  IgE levels will be noted at baseline six weeks and three months after glucocorticoid therapy and percentage decline will be calculated as: (baseline IgE levels minus IgE levels after six weeks of treatment) divided by baseline IgE levels

  6 weeks, 3 months

• Complete remission rates in the two groups

  No ABPA exacerbations over the next 3 months after stopping therapy

  3 months, 6 months

Secondary Outcomes (2)

• Relapse rates in the two groups at six and 12 months after completion of treatment

  6 months, 12 months

• Treatment related adverse effects in the two groups

  Every 6 weeks

Study Arms (2)

Itraconazole group

EXPERIMENTAL

Itraconazole 200 mg BD for 4 months along with inhaled formoterol/fluticasone (6/125 mcg) 2 puffs twice daily by MDI and as needed as per the SMART approach

Drug: Itraconazole

Glucocorticoid group

ACTIVE COMPARATOR

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 2 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) as needed as per the SMART approach for control of asthma

Drug: Glucocorticoids

Interventions

Glucocorticoids DRUG

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 2 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) as needed as per the SMART approach for control of asthma

Also known as: Prednisolone

Glucocorticoid group

Itraconazole DRUG

Itraconazole 200 mg BD for 6 months along with inhaled formoterol/fluticasone (6/125 mcg) 2 puffs twice daily by MDI and as needed as per the SMART approach

Also known as: Azole

Itraconazole group

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of all the following three criteria:
• immediate cutaneous hyperreactivity on aspergillus skin test
• elevated total IgE levels \> 1000 IU/mL
• A fumigatus specific IgE levels \> 0.35 kU/L
• Two of the following criteria:
• presence of serum precipitating antibodies against A fumigatus
• fixed or transient radiographic pulmonary opacities
• absolute eosinophil count \> 1000/µL
• central bronchiectasis on HRCT.

You may not qualify if:

• if they have taken glucocorticoids for more than three weeks in the preceding six months
• failure to give informed consent
• enrollment in another trial of ABPA

Sponsors & Collaborators

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

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, 160012, India

Location

Related Publications (1)

• Agarwal R, Dhooria S, Singh Sehgal I, Aggarwal AN, Garg M, Saikia B, Behera D, Chakrabarti A. A Randomized Trial of Itraconazole vs Prednisolone in Acute-Stage Allergic Bronchopulmonary Aspergillosis Complicating Asthma. Chest. 2018 Mar;153(3):656-664. doi: 10.1016/j.chest.2018.01.005. Epub 2018 Jan 11.

  PMID: 29331473 DERIVED

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Glucocorticoids; Prednisolone; Itraconazole; Azoles

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)

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

Study Officials

• Ritesh Agarwal, MD, DM

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

IN (1)