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NCT00021567 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double-Blinded, Placebo-Controlled, Phase II Inhaled Interferon Gamma-1b and Antimycobacterials to Treat Pulmonary Mycobacterium Avium Complex Infections
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00021567 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants.
The verdict
NCT00021567, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study will test the safety and effectiveness of inhaled interferon gamma-1b and oral antibiotics for treating mycobacterium avium complex (MAC) infection of the lungs. Patients 18 years of age or older with MAC infection of the lungs who 1) have been previously treated for MAC, or 2) have moderate or severe lung disease due to MAC that has not been previously treated may be eligible for this study. Participants will be randomly assigned to one of two treatment groups. Group 1 will receive 500 micrograms of interferon gamma-1b 3 times a week for 48 weeks by inhalation. Group 2 will inhale a placebo (inactive substance) according to the same regimen. In addition, all patients will receive standard MAC treatment with three antibiotics-clarithromycin or azithromycin, ethambutol and rifampin or rifabutin-taken by mouth times a week. Patients will come to the clinic for a screening visit, baseline visit, 1 month after beginning treatment, and at 3-month intervals thereafter until the end of the study. During these various visits, they will undergo the following tests and procedures: * Medical history and physical examination, including height and weight measurements, heart rate, breathing rate, blood pressure and temperature * Possibly computed tomography (CT) and X-ray of the lungs * Sputum sample * Pulmonary function studies * Blood and urine tests Patients' eyes will be examined monthly to check for side effects of ethambutol, and hearing and balance will be tested to check for side effects of clarithromycin or azithromycin. At the baseline visit, the patient or caretaker will be trained to use a nebulizer (a special breathing device) to take the study medication.
Interventions
- DRUG Interferon Gamma for Aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2001-07 |
| Est. Completion | 2002-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00021567
The ClinicalTrials.gov registry entry for NCT00021567 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interferon Gamma for Aerosol is the first listed.
NCT00021567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00021567 about?
NCT00021567 is a clinical study titled "A Randomized, Double-Blinded, Placebo-Controlled, Phase II Inhaled Interferon Gamma-1b and Antimycobacterials to Treat Pulmonary Mycobacterium Avium Complex Infections". This study will test the safety and effectiveness of inhaled interferon gamma-1b and oral antibiotics for treating mycobacterium avium complex (MAC) infection of the lungs. Patients 18 years of age or older with MAC infection of the lungs who 1) have been previously treated for MAC, or 2) have mode...
What is the current status of trial NCT00021567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2001-07. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00021567?
The interventions under investigation include: Interferon Gamma for Aerosol (DRUG).
Who is sponsoring clinical trial NCT00021567?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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