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

Tracking Information
First Received Date ^ICMJE	May 18, 2000
Last Updated Date	November 11, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Official Title ^ICMJE	A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety/Efficacy Study
Condition ^ICMJE	Aspergillosis Lung Diseases, Fungal
Intervention ^ICMJE	Drug: Itraconazole oral solution
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	96
Completion Date	November 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00005668
Responsible Party
Study ID Numbers ^ICMJE	DMID MSG 37, DMID 96-199, NIH/09021
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP