A Study in Pediatric Patients With Cystic Fibrosis Lung Disease - Full Text View

A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

This study has been completed.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00130182

Purpose

The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).

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

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

ChemIDplus related topics:

INS37217 Denufosol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

respiratory function

Secondary Outcome Measures:

adverse events
change in standard safety parameters
pulmonary exacerbation

Enrollment:	13
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	5 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have confirmed diagnosis of CF
Have an FEV1 greater than or equal to 60%
Have oxygen saturation greater than or equal to 90% on room air
Be clinically stable for at least 4 weeks prior to screening
Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

Have clinically significant comorbidities
Have changed their physiotherapy technique or schedule within 7 days prior to screening
Using prior and concurrent medications according to protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130182

Locations


United States, Colorado
	The Children's Hospital
	Denver, Colorado, United States, 80218

United States, Minnesota
	The Minnesota CF Center
	Minneapolis, Minnesota, United States, 55455
	General Clinic Research Center University of Minnesota
	Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators


Study Director:	Amy Schaberg, BSN	Inspire Pharmaceuticals

More Information

Study ID Numbers:	08-107
First Received:	August 11, 2005
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00130182
Health Authority:	United States: Food and Drug Administration