A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dey

ClinicalTrials.gov Identifier:

NCT00774761

First received: October 16, 2008

Last updated: February 26, 2013

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 16, 2008
Last Updated Date	February 26, 2013
Start Date ^ICMJE	November 2008
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2008)	Plasma AUC(0-t) after 1 week of dosing [ Time Frame: PK sampling over 24 hrs ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00774761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 16, 2008)	FEV1 [ Time Frame: pre-dose and 2 hrs post-dose ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Official Title ^ICMJE	A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary	The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Drug: fluticasone propionate/formoterol fumarate inhalation suspension Drug: fluticasone propionate inhalation suspension Drug: formoterol fumarate inhalation solution
Study Arm (s)	Experimental: 1 Intervention: Drug: fluticasone propionate/formoterol fumarate Experimental: 2 Intervention: Drug: fluticasone propionate/formoterol fumarate Active Comparator: 3 Intervention: Drug: fluticasone propionate Active Comparator: 4 Intervention: Drug: fluticasone propionate Active Comparator: 5 Intervention: Drug: formoterol fumarate
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	Completed
Enrollment ^ICMJE	97
Completion Date	May 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Able to understand the requirements of the study and provide consent Medical diagnosis of COPD A current or prior history of at least 10-pack years of cigarette smoking Female of child-bearing potential to use adequate birth control Exclusion Criteria: Diagnosis of asthma Other significant disease than COPD Has donated a unit of blood within 30 days of study, or intends to donate QTc greater than 0.460 seconds Subjects who had radiation or chemotherapy in the previous 12 months Subjects who had lung resection History of illegal drug abuse or alcohol abuse within the past 5 years
Gender	Both
Ages	40 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	NCT00774761
Other Study ID Numbers ^ICMJE	191-087
Has Data Monitoring Committee	No
Responsible Party	Dey
Study Sponsor ^ICMJE	Dey
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dey
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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