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

Completed · Phase 2

Conditions studied: Aspergillosis, Lung Diseases, Fungal

In brief

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.

Key facts

Study ID

NCT00005668

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

96

Expected to finish

2005-11-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• positive test for Aspergillus species.
• 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.

You may not qualify if…

• 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.

Where it is running

• Mary Ellen Bradley — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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