Cystic Fibrosis Research at University of Colorado Hospital

The Colorado Adult Cystic Fibrosis Program serves as a specialized center of clinical and investigative excellence. We have a number of clinical trials to study new therapies, observational studies and translational protocols that may lead to better treatments in the future. Areas of scientific interest include:

• Utilizing monocyte gene expression and circulating proteins as a biomarker of CF inflammation
• Studies of airway and nasal epithelia cells
• Sharing clinical samples with other investigators for pilot studies and hypothesis development

Ongoing Cystic Fibrosis Clinical Trials and Observational Studies

***Contact Marin Jones, (303) 398-1265, for more information on any of the cystic fibrosis studies listed below.

HS-2031 A Randomized, Double-blind Within Dose, Placebo-controlled Study To Investigate The Safety, Tolerability and Pharmacokinetics of Increasing Single And Multiple Doses (28-day dosing) of Tiotropium Bromide Administered Once Daily Via The Respimat Device in Cystic Fibrosis Patients (BI 205.338)

• Boehringer Ingelheim Pharmaceuticals
• 9/1/06 – present
• Jerry A. Nick, MD

HS-2136 ALTU-135: A Phase III, Open-Label Clinical Study Evaluating the Long-Term Safety and Clinical Activity of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency.

• Altus Pharmaceuticals Inc
• 9/1/07 – present
• Local P.I.: Jerry A. Nick, MD

A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects. Protocol Number: TIP003 A02

• Novartis
• 9/1/07 – present
• Local Site P.I.: Jerry A. Nick, MD

HS-2080 TOPIC: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal On Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease

• Genentech
• 4/1/07 – present
• Jerry A. Nick, MD

HS-1683: Participation in a Cystic Fibrosis Patient Registry.

• 7/04 – present
• Jerry A. Nick, MD

HS-2005CO: Project on Adult Care in Cystic Fibrosis

• 4/03 – present
• Jerry A. Nick, MD

HS-1755: Improving Performance of CF Centers in the Detection and Management of Cystic Fibrosis-Related Diabetes Mellitus

• 7/03 – present
• Jerry A. Nick, MD

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial with Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Pulmonary P. aeruginosa Requiring Frequent Antibiotics (AIRCF2).

• 2004 – present
• Frank Accurso, MD

A Pilot Study to Evaluate the Effects of Sildenafil Citrate on Exercise Tolerance and Pulmonary Function in Moderate to Severe Cystic Fibrosis Lung Disease

• 2005 – present
• Scott Segal, MD

PTC124 for the Treatment of Nonsense-Mutation-Mediated Cystic Fibrosis

• 12/05 – present
• Frank Accurso, MD