Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | July 2009 |
Source | Dey |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | April 2008 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Site | Abingdon | Virginia |
United States | Clinical Research Site | Albany | New York |
United States | Clinical Research Site | Atlanta | Georgia |
United States | Clinical Research Site | DeLand | Florida |
United States | Clinical Research Site | Greenville | South Carolina |
United States | Clinical Research Site | Livonia | Michigan |
United States | Clinical Research Site | Medford | Oregon |
United States | Clinical Research Site | Milwaukee | Wisconsin |
United States | Clinical Research Site | Mobile | Alabama |
United States | Clinical Research Site | North Syracuse | New York |
United States | Clinical Research Site | Phoenix | Arizona |
United States | Clinical Research Site | Portland | Oregon |
United States | Clinical Research Site | Richmond | Virginia |
United States | Clinical Research Site | San Antonio | Texas |
United States | Clinical Research Site | Spartanburg | South Carolina |
United States | Clinical Research Site | St. Charles | Missouri |
United States | Clinical Research Site | St. Louis | Missouri |
United States | Clinical Research Site | Toledo | Ohio |
United States | Clinical Research Site | Williamsville | New York |
Lead Sponsor | Collaborator |
---|---|
Dey |
United States,
Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 6 weeks |
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