Clinical trial NCT00671073: Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
COPD
COAD
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 427
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.


Eligibility criteria: Inclusion Criteria:

* Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC \<70%, and post-bronchodilator FEV1 \>30% and \< 80% predicted
* Current or former cigarette smoker

Exclusion Criteria:

* Long-term oxygen use of \> 15 hours a day
* Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
* Any COPD exacerbations within 30 days prior to study entry or during run-in
* History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
* Presence of clinical significant pulmonary disease other than COPD

Primary outcomes:
measure: Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Pre-bronchodilator forced vital capacity (FVC)
timeFrame: After 12 weeks of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site
state: Arizona
city: Buena Park
country: United States
facility: Forest Investigative Site
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site
state: California
city: Fullerton
country: United States
facility: Forest Investigative Site
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
city: Orange
country: United States
facility: Forest Investigative Site
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: Stockton
country: United States
facility: Forest Investigative Site
state: California
city: Centennial
country: United States
facility: Forest Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site WR1
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site WR2
state: Colorado
city: Waterbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site
state: Florida
city: Skokie
country: United States
facility: Forest Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Forest Investigative Site
state: Indiana
city: North Dartmouth
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Livonia
country: United States
facility: Forest Investigative Site
state: Michigan
city: Edina
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Papillion
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Elmira
country: United States
facility: Forest Investigative Site
state: New York
city: Mineola
country: United States
facility: Forest Investigative Site
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site
state: Ohio
city: Medford
country: United States
facility: Forest Investigative Site
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Bethlehem
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site
state: South Carolina
city: El Paso
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Fredericksburg
country: United States
facility: Forest Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Forest Investigative Site
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Brian T Maurer, MS
role: STUDY_DIRECTOR
References: