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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00005668
First received: May 18, 2000
Last updated: August 26, 2010
Last verified: November 2005

May 18, 2000
August 26, 2010
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Complete list of historical versions of study NCT00005668 on ClinicalTrials.gov Archive Site
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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
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Aspergillosis
  • Lung Diseases, Fungal
Drug: Itraconazole oral solution
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
November 2005
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005668
DMID MSG 37, DMID 96-199, NIH/09021
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP