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NCT00021567
A Randomized, Double-Blinded, Placebo-Controlled, Phase II Study of the Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterial in Previously Treated or Moderate to Severe Pulmonary Mycobacterium Avium Complex (MAC) Infection
Phase 2 trial testing Interferon Gamma for Aerosol in Mycobacterium Avium-Intracellulare Infection in 20 participants. Completed in 1 June 2002.
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 July 2001 |
| Estimated completion | 1 June 2002 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Interferon Gamma for Aerosol — full drug profile →
Conditions studied
- Mycobacterium Avium-Intracellulare Infection — all drugs for Mycobacterium Avium-Intracellulare Infection →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Eligibility, any sex, with Mycobacterium Avium-Intracellulare Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00021567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00021567 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 3 March 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00021567.
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