A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT00774761
First received: October 16, 2008
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: fluticasone propionate/formoterol fumarate
Drug: fluticasone propionate
Drug: formoterol fumarate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • Plasma AUC(0-t) after 1 week of dosing [ Time Frame: PK sampling over 24 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • FEV1 [ Time Frame: pre-dose and 2 hrs post-dose ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: fluticasone propionate/formoterol fumarate
inhalation suspension
Experimental: 2 Drug: fluticasone propionate/formoterol fumarate
inhalation suspension
Active Comparator: 3 Drug: fluticasone propionate
inhalation suspension
Active Comparator: 4 Drug: fluticasone propionate
inhalation suspension
Active Comparator: 5 Drug: formoterol fumarate
inhalation solution

  Eligibility

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

Inclusion Criteria:

  • Able to understand the requirements of the study and provide consent
  • Medical diagnosis of COPD
  • A current or prior history of at least 10-pack years of cigarette smoking
  • Female of child-bearing potential to use adequate birth control

Exclusion Criteria:

  • Diagnosis of asthma
  • Other significant disease than COPD
  • Has donated a unit of blood within 30 days of study, or intends to donate
  • QTc greater than 0.460 seconds
  • Subjects who had radiation or chemotherapy in the previous 12 months
  • Subjects who had lung resection
  • History of illegal drug abuse or alcohol abuse within the past 5 years
  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: NCT00774761

Locations
United States, California
Investigative Site
San Diego, California, United States, 92120
United States, Florida
Investigative Site
Panama City, Florida, United States, 32405
United States, Kentucky
Investigative Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Investigative Site
Sunset, Louisiana, United States, 70584
United States, North Carolina
Investigative Site
Charlotte, North Carolina, United States, 28207
United States, Oregon
Investigative Site
Medford, Oregon, United States, 97504
United States, South Carolina
Investigative Site
Greenville, South Carolina, United States, 29615
Investigative Site
Spartanburg, South Carolina, United States, 29303
Investigative Site
Union, South Carolina, United States, 29379
United States, Texas
Investigative Site
San Antonio, Texas, United States, 78205
United States, Washington
Investigative Site
Spokane, Washington, United States, 99207
Investigative Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Dey
  More Information

No publications provided

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT00774761     History of Changes
Other Study ID Numbers: 191-087
Study First Received: October 16, 2008
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
Chronic
Obstructive
Pulmonary
Disease
COPD
Pharmacodynamic
Pharmacokinetic

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014