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.

Condition	Treatment or Intervention	Phase
Aspergillosis Lung Diseases, Fungal	Drug: Itraconazole oral solution	Phase II

Further Study Details: 

Expected Total Enrollment:  96

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

a) positive test for Aspergillus species.

b) 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.

Alabama
      Mary Ellen Bradley, Birmingham,  Alabama,  35294,  United States

Study ID Numbers:  DMID MSG 37; DMID 96-199; NIH/09021
Record last reviewed:  December 2000
Last Updated:  October 13, 2004
Record first received:  May 18, 2000
ClinicalTrials.gov Identifier:  NCT00005668
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08