Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Official title:

A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274313
• Other study ID #: Parion 552-203
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 6, 2006
• Last updated: January 12, 2009
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: January 2009
• Source: Parion Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• 552-02

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Children's Memorial Hospital	Chicago	Illinois
United States	The Children's Hospital	Denver	Colorado
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Nemours Children's Clinic	Orlando	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
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	State University of New York Upstate	Syracuse	New York
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Parion Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments
Primary	Blood and urine laboratory tests
Primary	Pulmonary function tests
Primary	Electrocardiograms
Primary	Vital signs and pulse oximetry
Secondary	Plasma pharmacokinetics on Day 14 of the study.