Study in Subjects Greater Than 40 Years of Age With COPD

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00507234
First received: July 24, 2007
Last updated: November 10, 2010
Last verified: July 2009
  Purpose

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

  1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
  2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: formoterol fumarate inhalation solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET). [ Time Frame: 6 weeks ]

Enrollment: 128
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Medical diagnosis of COPD
  • Current or prior history of cigarette smoking

Exclusion Criteria:

  • Medical diagnosis of asthma
  • Significant condition or disease other than COPD
  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: NCT00507234

Locations
United States, Alabama
Clinical Research Site
Mobile, Alabama, United States, 36695
United States, Arizona
Clinical Research Site
Phoenix, Arizona, United States, 85006
United States, Florida
Clinical Research Site
DeLand, Florida, United States, 32720
United States, Georgia
Clinical Research Site
Atlanta, Georgia, United States, 30330
United States, Michigan
Clinical Research Site
Livonia, Michigan, United States, 48152
United States, Missouri
Clinical Research Site
St. Charles, Missouri, United States, 63301
Clinical Research Site
St. Louis, Missouri, United States, 63141
United States, New York
Clinical Research Site
Albany, New York, United States, 12205
Clinical Research Site
North Syracuse, New York, United States, 13212
Clinical Research Site
Williamsville, New York, United States, 14221
United States, Ohio
Clinical Research Site
Toledo, Ohio, United States, 45560
United States, Oregon
Clinical Research Site
Medford, Oregon, United States, 97504
Clinical Research Site
Portland, Oregon, United States, 97213
United States, South Carolina
Clinical Research Site
Greenville, South Carolina, United States, 29615
Clinical Research Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Clinical Research Site
San Antonio, Texas, United States, 78229
United States, Virginia
Clinical Research Site
Abingdon, Virginia, United States, 24210
Clinical Research Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
Clinical Research Site
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Dey
Investigators
Principal Investigator: Nicola A Hanania, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00507234     History of Changes
Other Study ID Numbers: 201-080
Study First Received: July 24, 2007
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
COPD

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

ClinicalTrials.gov processed this record on September 16, 2014