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Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis

NCT01321827 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-03-16

No results posted yet for this study

Summary

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

Conditions

  • Allergic Bronchopulmonary Aspergillosis

Interventions

DRUG

Glucocorticoids

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

Itraconazole

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

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Ritesh Agarwal, MD, DM · PGIMER, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-03-31
Completion
2015-12-31

Countries

  • India

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01321827 on ClinicalTrials.gov