A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	Dey
Information provided by:	Dey
ClinicalTrials.gov Identifier:	NCT00403286

Purpose

The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Fluticasone Propionate/Formoterol Fumarate Drug: Fluticasone Propionate Drug: Formoterol Fumarate Drug: Fluticasone Propionate/Salmeterol Xinafoate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:

2-hour post-dose FEV1 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
AUC(0-12) and Cmax in plasma [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
pre-dose FEV1 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Amount and percent total dose excreted in urine [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

FEV1 AUC(0-2) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
COPD exacerbations
Treatment Emergent Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	457
Study Start Date:	November 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: C 10/1	Drug: Fluticasone Propionate/Formoterol Fumarate Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Experimental: C 5/2	Drug: Fluticasone Propionate/Formoterol Fumarate Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Experimental: C 5/1	Drug: Fluticasone Propionate/Formoterol Fumarate Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Experimental: FP 1000	Drug: Fluticasone Propionate Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
Experimental: FF 20	Drug: Formoterol Fumarate Inhalation Solution for nebulization 20 mcg bid for 2 weeks
Active Comparator: AD 250/50	Drug: Fluticasone Propionate/Salmeterol Xinafoate Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
Placebo Comparator: Plc	Drug: Placebo Inhalation Solution for nebulization 2 mL bid for 2 weeks
Experimental: C 10/2	Drug: Fluticasone Propionate/Formoterol Fumarate Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of COPD
Female of child-bearing potential to use adequate birth control
Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
Meet lung function requirements

Exclusion Criteria:

Diagnosis of asthma
Other significant disease than COPD
Pregnant or lactating female
Female planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403286

Show 49 Study Locations

Sponsors and Collaborators

Dey

More Information

No publications provided

Responsible Party:	Director Clinical Affairs, Dey, L.P.
ClinicalTrials.gov Identifier:	NCT00403286 History of Changes
Other Study ID Numbers:	191-076
Study First Received:	November 21, 2006
Last Updated:	June 26, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

Chronic
Obstructive
Pulmonary
Disease
COPD

Safety
Efficacy
Pharmacokinetic
Dose-finding

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Salmeterol
Albuterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012