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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043316
First Posted: August 9, 2002
Last Update Posted: November 1, 2007
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:
InterMune
August 7, 2002
August 9, 2002
November 1, 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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
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