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

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

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.

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

Intervention(s) in this Clinical Trial

• Drug: Itraconazole oral solution

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Institute of Allergy and Infectious Diseases (NIAID) NIH

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00005668

Study ID Number: DMID MSG 37

ClinicalTrials.gov Identifier: NCT00005668

Health Authority: United States: Federal Government