NCT00274313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

First QC Date

January 6, 2006

Last Update Submit

January 12, 2009

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Outcome Measures

Primary Outcomes (5)

  • Safety assessments

  • Blood and urine laboratory tests

  • Pulmonary function tests

  • Electrocardiograms

  • Vital signs and pulse oximetry

Secondary Outcomes (1)

  • Plasma pharmacokinetics on Day 14 of the study.

Interventions

552-02DRUG

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of California at San Diego

San Diego, California, 92161, United States

Location

University of California at San Francisco Medical Center

San Francisco, California, 94143-0359, United States

Location

The Children's Hospital

Denver, Colorado, 80218, United States

Location

Nemours Children's Clinic

Orlando, Florida, 32806-1101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5190, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

State University of New York Upstate

Syracuse, New York, 13210, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4399, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 10, 2006

Study Start

January 1, 2006

Study Completion

August 1, 2006

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

US(15)