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

Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005668
• Other study ID #: DMID MSG 37
• Secondary ID: DMID 96-199NIH/0
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2000
• Last updated: August 26, 2010
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Lung Diseases
• Lung Diseases, Fungal

Intervention

Drug:
• Itraconazole oral solution

Locations

Country	Name	City	State
United States	Mary Ellen Bradley	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,