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

Tracking Information

First Received Date ^ICMJE

August 7, 2002

Last Updated Date

October 29, 2007

Start Date ^ICMJE

February 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in FEV1, sputum bacterial density [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: interferon gamma-1b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00043316

Responsible Party

Study ID Numbers ^ICMJE

GICF-001

Study Sponsor ^ICMJE

InterMune

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Steve Porter, MD

InterMune

Information Provided By

InterMune

Verification Date

October 2007

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