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

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00403286
First received: November 21, 2006
Last updated: June 26, 2009
Last verified: June 2009
  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 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

  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 April 16, 2014