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

Primary Purpose

Aspergillosis, Lung Diseases, Fungal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Itraconazole oral solution
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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. 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.

Sites / Locations

  • Mary Ellen Bradley

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 18, 2000
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00005668
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Lung Diseases, Fungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
96 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Itraconazole oral solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 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.
Facility Information:
Facility Name
Mary Ellen Bradley
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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