A Study in Adult and Pediatric Patients With Cystic Fibrosis

This study has been completed.

First Received: April 29, 2002 Last Updated: September 13, 2005 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00034515

Purpose

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis

Condition	Intervention	Phase
Cystic Fibrosis	Drug: denufosol tetrasodium (INS37217) Inhalation Solution	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Denufosol INS37217

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

assess safety and tolerability

Secondary Outcome Measures:

assess effects of INS37217 on sputum weight and symptoms

Estimated Enrollment:	72
Study Start Date:	June 2001
Estimated Study Completion Date:	October 2002

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

FEV1 40-70% (adults)
FEV1 >/=50% (pediatrics)
oxygen saturation >90%
clinically stable
willing to stay overnight

Exclusion Criteria:

abnormal renal or liver function
receiving corticosteroids exceeding 10mg/day or 20 mg every other day
received intravenous or aerosolized antibiotics 1 week prior to dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034515

Locations

United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Unaffiliated

More Information

No publications provided

Study ID Numbers:	08-102
Study First Received:	April 29, 2002
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00034515 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on July 02, 2009