Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274313
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : January 14, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: 552-02 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : January 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety assessments
  2. Blood and urine laboratory tests
  3. Pulmonary function tests
  4. Electrocardiograms
  5. Vital signs and pulse oximetry

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274313

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 Identifier: NCT00274313     History of Changes
Other Study ID Numbers: Parion 552-203
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by Parion Sciences:
Cystic Fibrosis

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