Study in Subjects Greater Than 40 Years of Age With COPD
This study has been completed.
Sponsor:
Dey
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00507234
First received: July 24, 2007
Last updated: November 10, 2010
Last verified: July 2009
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Purpose
This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.
The objectives of this study are:
- 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.
- 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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Formoterol 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 |
ClinicalTrials.gov processed this record on May 23, 2013