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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403286
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
Dey

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Fluticasone Propionate/Formoterol Fumarate Drug: Fluticasone Propionate Drug: Formoterol Fumarate Drug: Fluticasone Propionate/Salmeterol Xinafoate Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 2-hour post-dose FEV1 [ Time Frame: 2 weeks ]
  2. AUC(0-12) and Cmax in plasma [ Time Frame: 2 weeks ]
  3. pre-dose FEV1 [ Time Frame: 2 weeks ]
  4. Amount and percent total dose excreted in urine [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. FEV1 AUC(0-2) [ Time Frame: 2 weeks ]
  2. COPD exacerbations
  3. Treatment Emergent Adverse Events [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403286


Locations
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Sponsors and Collaborators
Dey
More Information
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Responsible Party: Director Clinical Affairs, Dey, L.P.
ClinicalTrials.gov Identifier: NCT00403286    
Other Study ID Numbers: 191-076
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009
Keywords provided by Dey:
Chronic
Obstructive
Pulmonary
Disease
COPD
 Safety
Efficacy
Pharmacokinetic
Dose-finding
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Xhance
Formoterol Fumarate
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action