Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease - Full Text View

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00357279

Purpose

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: denufosol tetrasodium (INS37217) Inhalation Solution Drug: Placebo - 0.9% w/v sodium chloride solution	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Sodium chloride Chlorides INS37217 Denufosol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Change in lung function [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pulmonary exacerbation [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Requirements for concomitant CF medications [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	July 2006
Study Completion Date:	September 2008

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo - 0.9% w/v sodium chloride solution 4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.
2: Experimental	Drug: denufosol tetrasodium (INS37217) Inhalation Solution Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

Eligibility

Ages Eligible for Study:	5 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 75% 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 suggesting clinically significant active pulmonary disease
Be colonized with Burkholderia cepacia
Have had a lung transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357279

Show 81 Study Locations

Sponsors and Collaborators

Inspire Pharmaceuticals

More Information

Responsible Party:	Inspire Pharmaceuticals ( Amy Schaberg, RN, BSN Vice President Respiratory Clinical Research )
Study ID Numbers:	08-108
Study First Received:	July 25, 2006
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00357279
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
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009