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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 21, 2006
Last updated: June 26, 2009
Last verified: June 2009
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 2

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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators
  More Information

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:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Formoterol Fumarate
Salmeterol Xinafoate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016