Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

This study has been terminated.

First Received: January 19, 2007 Last Updated: January 29, 2009 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00425165

Purpose

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

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:

Change in mucociliary clearance from baseline [ Time Frame: 30, 60, and 90 minutes post aerosol inhalation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

No secondary outcome measure [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	July 2007
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Denufosol 60 mg is administered as an inhalation solution one time during the study.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

have confirmed diagnosis of cystic fibrosis
have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
be able to reproducibly perform spirometry maneuvers
be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

have abnormal renal or liver function
have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
have had a lung transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425165

Locations

United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27514

Sponsors and Collaborators

Inspire Pharmaceuticals

More Information

No publications provided

Responsible Party:	Inspire Pharmacauticals ( Amy Schaberg, RN, BSN, Vice President, Respiratory Clinical Research )
Study ID Numbers:	08-111
Study First Received:	January 19, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00425165 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 September 02, 2009