Clinical trial NCT00076089: OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
Official title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
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: 2004-01-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Main Inclusion Criteria:

* FEV1/FVC ratio (post-bronchodilator) ≤70%
* FEV1 (post-bronchodilator) ≤50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as ≥16 hours/day

Primary outcomes:
measure: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary outcomes:
measure: pulmonary function variables
measure: number of COPD exacerbations of different type and various subgroups
measure: quality of life variables
measure: patient diary variables
measure: time to study withdrawal
measure: safety.
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 Arkansas
country: United States
facility: ALTANA Pharma
state: Arkansas
city: Cities in California
country: United States
facility: ALTANA Pharma
state: California
city: Cities in Colorado
country: United States
facility: ALTANA Pharma
state: Colorado
city: Cities in Connecticut
country: United States
facility: ALTANA Pharma
state: Connecticut
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 Illionois
country: United States
facility: ALTANA Pharma
state: Illinois
city: Cities in Iowa
country: United States
facility: ALTANA Pharma
state: Iowa
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 Massachusetts
country: United States
facility: ALTANA Pharma
state: Massachusetts
city: Cities in Minnesota
country: United States
facility: ALTANA Pharma
state: Minnesota
city: Cities in Missouri
country: United States
facility: ALTANA Pharma
state: Missouri
city: Cities in Montana
country: United States
facility: ALTANA Pharma
state: Montana
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 Hampshire
country: United States
facility: ALTANA Pharma
state: New Hampshire
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 Oklahoma
country: United States
facility: ALTANA Pharma
state: Oklahoma
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 Tennessee
country: United States
facility: ALTANA Pharma
state: Tennessee
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 Vermont
country: United States
facility: ALTANA Pharma
state: Vermont
city: Cities in Virginia
country: United States
facility: ALTANA Pharma
state: Virginia
city: Cities in West Virginia
country: United States
facility: ALTANA Pharma
state: West Virginia
city: Cities in Wisconsin
country: United States
facility: ALTANA Pharma
state: Wisconsin
city: Cities in Canada
country: Canada
facility: ALTANA Pharma
city: Cities in France
country: France
facility: ALTANA Pharma
city: Cities in Germany
country: Germany
facility: ALTANA Pharma
city: Cities in Poland
country: Poland
facility: ALTANA Pharma
city: Cities in South Africa
country: South Africa
facility: ALTANA Pharma
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
citation: Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.