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

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00425165

First received: January 19, 2007

Last updated: March 31, 2011

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 19, 2007
Last Updated Date	March 31, 2011
Start Date ^ICMJE	July 2007
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 14, 2007)	Change in mucociliary clearance from baseline [ Time Frame: 30, 60, and 90 minutes post aerosol inhalation ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 19, 2007)	Change in mucociliary clearance from baseline
Change History	Complete list of historical versions of study NCT00425165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Cystic Fibrosis
Intervention ^ICMJE	Drug: denufosol tetrasodium (INS37217) Inhalation Solution Denufosol 60 mg is administered as an inhalation solution one time during the study.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	6
Completion Date	Not Provided
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	10 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00425165
Other Study ID Numbers ^ICMJE	08-111
Has Data Monitoring Committee	No
Responsible Party	Amy Schaberg, RN, BSN, Vice President, Respiratory Clinical Research, Inspire Pharmacauticals
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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