A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

NCT ID: NCT00005668

Last Updated: 2010-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-11-30

Brief Summary

To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.

Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

Detailed Description

Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.

Conditions

Aspergillosis; Lung Diseases, Fungal

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Itraconazole oral solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are 18 years of age or older.
• Have been diagnosed with aspergilloma within the last month.
• Have (or have a history of) at least one of the following:

1. positive test for Aspergillus species.

2. presence of antibodies to Aspergillus.

• Are willing to participate in the study for 2 full years.
• Are female and not pregnant.
• Are not breast-feeding.
• Agree to use barrier methods of birth control / contraception during the study and for 30 days after.

Exclusion Criteria

You will not be eligible for this study if you:

• Have a history of allergy to triazole or imidazole drugs.
• Are unable to take oral medication.
• Are not expected to live for more than a month.
• Have had a lung biopsy indicating Aspergillus infection.
• Have had radiation therapy within the last 6 months.
• Require treatment with certain medications.
• Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
• Received chemotherapy within the last 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Locations

Mary Ellen Bradley

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

DMID 96-199

Identifier Type: -

Identifier Source: secondary_id

NIH/09021

Identifier Type: -

Identifier Source: secondary_id

DMID MSG 37

Identifier Type: -

Identifier Source: org_study_id