Clinical trial NCT00062582: Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)
Official title: A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: Roflumilast
Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-06-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.


Eligibility criteria: Main Inclusion Criteria:

* Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
* Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

* Clinical diagnosis of asthma
* Poorly controlled COPD
* Regular need for daily oxygen therapy

Primary outcomes:
measure: pulmonary function.
Secondary outcomes:
measure: exacerbation rate
measure: quality of life
measure: symptoms
measure: use of rescue medication
measure: safety and tolerability.
Other outcomes:
Locations:
city: Cities in Alabama
country: United States
facility: ALTANA Pharma
state: Alabama
city: Cities in Arizona
country: United States
facility: ALTANA Pharma
state: Arizona
city: Cities in California
country: United States
facility: ALTANA Pharma
state: California
city: Cities in Colorado
country: United States
facility: ATLANA Pharma
state: Colorado
city: Cities in Conneticut
country: United States
facility: ALTANA Pharma
state: Connecticut
city: Cities in Delaware
country: United States
facility: ALTANA Pharma
state: Delaware
city: Cities in Florida
country: United States
facility: ALTANA Pharma
state: Florida
city: Cities in Georgia
country: United States
facility: ALTANA Pharma
state: Georgia
city: Cities in Idaho
country: United States
facility: ALTANA Pharma
state: Idaho
city: Cities in Indiana
country: United States
facility: ALTANA Pharma
state: Indiana
city: Cities in Iowa
country: United States
facility: ALTANA Pharma
state: Iowa
city: Cities in Kansas
country: United States
facility: ALTANA Pharma
state: Kansas
city: Cities in Kentucky
country: United States
facility: ALTANA Pharma
state: Kentucky
city: Cities in Louisiana
country: United States
facility: ALTANA Pharma
state: Louisiana
city: Cities in Maryland
country: United States
facility: ALTANA Pharma
state: Maryland
city: Cities in Michigan
country: United States
facility: ALTANA Pharma
state: Michigan
city: Cities in Missouri
country: United States
facility: ALTANA Pharma
state: Missouri
city: Cities in Nebraska
country: United States
facility: ALTANA Pharma
state: Nebraska
city: Cities in Nevada
country: United States
facility: ALTANA Pharma
state: Nevada
city: Cities in New Jersey
country: United States
facility: ALTANA Pharma
state: New Jersey
city: Cities in New York
country: United States
facility: ALTANA Pharma
state: New York
city: Cities in North Carolina
country: United States
facility: ALTANA Pharma
state: North Carolina
city: Cities in Ohio
country: United States
facility: ALTANA Pharma
state: Ohio
city: Cities in Oregon
country: United States
facility: ALTANA Pharma
state: Oregon
city: Cities in Pennsylvania
country: United States
facility: ALTANA Pharma
state: Pennsylvania
city: Cities in Rhode Island
country: United States
facility: ALTANA Pharma
state: Rhode Island
city: Cities in South Carolina
country: United States
facility: ALTANA Pharma
state: South Carolina
city: Cities in Texas
country: United States
facility: ALTANA Pharma
state: Texas
city: Cities in Utah
country: United States
facility: ALTANA Pharma
state: Utah
city: Cities in Virginia
country: United States
facility: ALTANA Pharma
state: Virginia
city: Cities in Washington
country: United States
facility: ALTANA Pharma
state: Washington
city: Cities in West Virginia
country: United States
facility: ALTANA Pharma
state: West Virginia
city: Cities in Argentina
country: Argentina
facility: ALTANA Pharma
city: Cities in Canada
country: Canada
facility: ALTANA Pharma
city: Cities in Colombia
country: Colombia
facility: ALTANA Pharma
city: Cities in Mexico
country: Mexico
facility: ALTANA Pharma
city: Cities in Peru
country: Peru
facility: ALTANA Pharma
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: