Years

Study Title

Status

Sponsor

Role*

Comments

2003- Ongoing

Phase IB Study of SLIT^TM Amikacin (TR02) in CF Patients Infected with P. aeruginosa

Ongoing

Transave

L

1 enrolled and completed.  Screening ongoing

2004- Ongoing

Phase 2 study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated CF

Enrollment complete.  Primary analysis complete, secondary analysis ongoing.

PTC

Therapeutics

L

5 enrolled, 7 screened,

4 sites

2004- Ongoing

Nasal Study – Suppression of STOP Mutations in CF Cells, Tissues, Patients

Development

NIH –

submitted

L

1^st NIH submission using TDN infrastructure, 5 sites (Emory, Pittsburgh, Seattle, Harvard, UAB)

2004- Ongoing

Phase I/II Study of Safety and Tolerability of TOFIN™ in Patients with CF Infected with P aeruginosa

Development

Source CF

L

Junior Investigator as site PI and lead PI for TDN, Mentors: JP Clancy and Randy Young

2004- Ongoing

Pulmonary Study – Suppression of STOP Mutations in CF Cells, Tissues, Patients

Development

NIH –

submitted

L

1^st NIH submission using TDN infrastructure, 5 sites (Emory, Pittsburgh, Seattle, Harvard, UAB)

2003-2005

A Multicenter, Double-Blind, Placebo-Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of CF

Complete

Targeted Genetics Corporation

P, M

10 enrolled and completed, exceeded enrollment goals

2004-2005

A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™-Total In CF Subjects with Exocrine Pancreatic Insufficiency

Complete

Altus

Biologics, Inc

P, M

4 enrolled and completed

2004- Ongoing

Assessment of Induced Sputum as a Tool to Evaluate Anti Inflammatory Agents in Patients with CF

Enrollment

completed, in data analysis

CFF

Therapeutics Inc.

P, M

 7 enrolled and completed