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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005668
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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.


Condition Intervention Phase
Aspergillosis Lung Diseases, Fungal Drug: Itraconazole oral solution Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 96
Estimated Study Completion Date: November 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005668


Locations
United States, Alabama
Mary Ellen Bradley
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

ClinicalTrials.gov Identifier: NCT00005668     History of Changes
Other Study ID Numbers: DMID MSG 37
DMID 96-199
NIH/09021
First Submitted: May 18, 2000
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
Last Verified: November 2005

Additional relevant MeSH terms:
Lung Diseases
Aspergillosis
Lung Diseases, Fungal
Mycoses
Respiratory Tract Diseases
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Skin Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors