Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00274313
- Lead Sponsor
- Parion Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety assessments Blood and urine laboratory tests Pulmonary function tests Electrocardiograms Vital signs and pulse oximetry
- Secondary Outcome Measures
Name Time Method Plasma pharmacokinetics on Day 14 of the study.
Trial Locations
- Locations (15)
University of South Florida
🇺🇸Tampa, Florida, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
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
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, 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
Nemours Children's Clinic
🇺🇸Orlando, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States