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

Phase 2

Completed

• Conditions: Aspergillosis; Lung Diseases, Fungal

• Registration Number: NCT00005668
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study First Submitted: 2000-05-18
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2005-11
• Study Completion: 2005-11
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mary Ellen Bradley; 🇺🇸 Birmingham, Alabama, United States