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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: Aspergillosis; Lung Diseases, Fungal

Treatments: Drug: Itraconazole oral solution

Study type: Interventional

Funder types: NIH

Identifiers

NCT00005668

DMID 96-199

NIH/09021

DMID MSG 37

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.