Status:
COMPLETED
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients
Lead Sponsor:
Parion Sciences
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14+ years
Phase:
PHASE1
PHASE2
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 f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00274313
Start Date
January 1 2006
End Date
August 1 2006
Last Update
January 14 2009
Active Locations (15)
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1
University of California at San Diego
San Diego, California, United States, 92161
2
University of California at San Francisco Medical Center
San Francisco, California, United States, 94143-0359
3
The Children's Hospital
Denver, Colorado, United States, 80218
4
Nemours Children's Clinic
Orlando, Florida, United States, 32806-1101