Clinical trial NCT00507234: Study in Subjects Greater Than 40 Years of Age With COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Clinical Research Site
state: Alabama
city: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
city: DeLand
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Livonia
country: United States
facility: Clinical Research Site
state: Michigan
city: St. Charles
country: United States
facility: Clinical Research Site
state: Missouri
city: St. Louis
country: United States
facility: Clinical Research Site
state: Missouri
city: Albany
country: United States
facility: Clinical Research Site
state: New York
city: North Syracuse
country: United States
facility: Clinical Research Site
state: New York
city: Williamsville
country: United States
facility: Clinical Research Site
state: New York
city: Toledo
country: United States
facility: Clinical Research Site
state: Ohio
city: Medford
country: United States
facility: Clinical Research Site
state: Oregon
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Greenville
country: United States
facility: Clinical Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Clinical Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
city: Abingdon
country: United States
facility: Clinical Research Site
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Site
state: Virginia
city: Milwaukee
country: United States
facility: Clinical Research Site
state: Wisconsin
Study officials:
affiliation: Baylor College of Medicine
name: Nicola A Hanania, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2009 Jun 18;69(9):1205-16. doi: 10.2165/00003495-200969090-00005.