Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

Completed · Phase 1/Phase 2

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.

Key facts

Study ID

NCT00274313

Run by

Parion Sciences

People needed

40

Starts

2006-01-01

Expected to finish

2006-08-01

Last updated by the study team

2009-01-14

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged > 14 years.
• Patients who are diagnosed with cystic fibrosis.
• Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
• Patients who are able to perform reproducible spirometry according to ATS guidelines.
• Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.

You may not qualify if…

• Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
• Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
• Patients on angiotensin converting enzyme (ACE) inhibitors.
• Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
• Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
• Patients who are pregnant, have a positive pregnancy test, or are nursing.
• Patients who have had a lung transplant.

Where it is running

• University of California at San Diego — San Diego, California, United States
• University of California at San Francisco Medical Center — San Francisco, California, United States
• The Children's Hospital — Denver, Colorado, United States
• Nemours Children's Clinic — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• State University of New York Upstate — Syracuse, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.