NCT00073463

Brief Summary

The purpose of this study is to confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of Cystic Fibrosis (CF).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

First QC Date

November 21, 2003

Last Update Submit

January 24, 2008

Conditions

Cystic Fibrosis

Keywords

Gene TransferPulmonary function

Interventions

tgAAVCFGENETIC

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligible subjects will be randomized to two aerosolized doses of either tgAAVCF or placebo 30 days apart. Subjects will undergo pulmonary function testing every two weeks during the active portion of the study (three months) and will be followed for safety for a total of seven months.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

UAB-Childrens Health System

Birmingham, Alabama, 35233, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

UC San Diego

San Diego, California, 92123, United States

Location

University of Colorado-The Childrens Hospital

Denver, Colorado, 80209, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

The Minnesota CF Center

Minneapolis, Minnesota, 55455, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2003

First Posted

November 25, 2003

Study Start

June 1, 2003

Study Completion

October 1, 2005

Last Updated

January 28, 2008

Record last verified: 2008-01

Locations

US(11)