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

Verified by: Dey, June 2009
First Received: November 21, 2006 | Last Updated: June 26, 2009 | Phase: Phase 2 | Start Date: November 2006
Overall Status: Completed | Estimated Enrollment: 457
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

  • Drug: Fluticasone Propionate/Formoterol Fumarate
    • Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
  • Drug: Fluticasone Propionate/Formoterol Fumarate
    • Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
  • Drug: Fluticasone Propionate/Formoterol Fumarate
    • Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
  • Drug: Fluticasone Propionate/Formoterol Fumarate
    • Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
  • Drug: Fluticasone Propionate
    • Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
  • Drug: Formoterol Fumarate
    • Inhalation Solution for nebulization 20 mcg bid for 2 weeks
  • Drug: Fluticasone Propionate/Salmeterol Xinafoate
    • Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
  • Drug: Placebo
    • Inhalation Solution for nebulization 2 mL bid for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: C 10/1
  • Experimental: C 5/2
  • Experimental: C 5/1
  • Experimental: FP 1000
  • Experimental: FF 20
  • Active Comparator: AD 250/50
  • Placebo Comparator: Plc
  • Experimental: C 10/2

Outcome Measures for this Clinical Trial

Primary Measures

  • 2-hour post-dose FEV1
    • Time Frame: 2 weeks
      Safety Issue?: No
  • AUC(0-12) and Cmax in plasma
    • Time Frame: 2 weeks
      Safety Issue?: Yes
  • pre-dose FEV1
    • Time Frame: 2 weeks
      Safety Issue?: No
  • Amount and percent total dose excreted in urine
    • Time Frame: 2 weeks
      Safety Issue?: Yes

Secondary Measures

  • FEV1 AUC(0-2)
    • Time Frame: 2 weeks
      Safety Issue?: No
  • COPD exacerbations
  • Treatment Emergent Adverse Events
    • Time Frame: 2 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Dey Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00403286

Study ID Number: 191-076

ClinicalTrials.gov Identifier: NCT00403286

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00403286