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Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

This study has been completed.
Sponsor:
Information provided by:
Parion Sciences
ClinicalTrials.gov Identifier:
NCT00274313
First received: January 6, 2006
Last updated: January 12, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: 552-02
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Parion Sciences:

Primary Outcome Measures:
  • Safety assessments
  • Blood and urine laboratory tests
  • Pulmonary function tests
  • Electrocardiograms
  • Vital signs and pulse oximetry

Secondary Outcome Measures:
  • Plasma pharmacokinetics on Day 14 of the study.

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
  2. 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.
  3. Patients on angiotensin converting enzyme (ACE) inhibitors.
  4. Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine > 2.0 mg/dL.
  5. Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
  6. Patients who are pregnant, have a positive pregnancy test, or are nursing.
  7. Patients who have had a lung transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274313

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92161
University of California at San Francisco Medical Center
San Francisco, California, United States, 94143-0359
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Orlando, Florida, United States, 32806-1101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5190
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
State University of New York Upstate
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Parion Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00274313     History of Changes
Other Study ID Numbers: Parion 552-203
Study First Received: January 6, 2006
Last Updated: January 12, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Parion Sciences:
Cystic Fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014