Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043316
First received: August 7, 2002
Last updated: October 29, 2007
Last verified: October 2007

August 7, 2002
October 29, 2007
February 2001
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change in FEV1, sputum bacterial density [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00043316 on ClinicalTrials.gov Archive Site
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Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks.

The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cystic Fibrosis
Drug: interferon gamma-1b
500 or 1000 mcg, inhalation, 3x per week
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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
66
October 2002
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Key inclusion criteria:

  • At least 12 years of age
  • Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment
  • Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration·
  • Other specific diagnostic indicators of CF and other factors must meet minimum requirements.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043316
GICF-001
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InterMune
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Study Director: Steve Porter, MD InterMune
InterMune
October 2007

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