Clinical trial NCT00073177: Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
Official title: A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-11-19
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 effects of oral roflumilast with placebo on lung function in patients with asthma.


Eligibility criteria: Main Inclusion Criteria:

* Persistent bronchial asthma
* No change in asthma treatment within 4 weeks prior to visit 1
* Non-smoker or ex-smoker (for 12 months or longer)

Main Exclusion Criteria:

* Poorly controlled asthma or seasonal asthma
* History of lower airway infection four weeks prior to visit 1
* Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
* Patients using \> 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
* Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
* Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
* Patients with chronic heart failure
* Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
* Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
* Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study

Primary outcomes:
measure: change in lung function from baseline to final visit.
Secondary outcomes:
measure: pulmonary function variables
measure: diary variables
measure: quality of life variables
measure: time to first exacerbation
measure: number of asthma exacerbations
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 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 Illinois
country: United States
facility: ALTANA Pharma
state: Illinois
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: Massachusetts
country: United States
facility: ALTANA Pharma
state: Massachusetts
city: Cities in Michigan
country: United States
facility: ALTANA Pharma
state: Michigan
city: Cities in Minnesota
country: United States
facility: ALTANA Pharma
state: Minnesota
city: Cities in Mississippi
country: United States
facility: ALTANA Pharma
state: Mississippi
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 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 North Dakota
country: United States
facility: ALTANA Pharma
state: North Dakota
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 Virginia
country: United States
facility: ALTANA Pharma
state: Virginia
city: Cities in Washington
country: United States
facility: ALTANA Pharma
state: Washington
city: Cities in Wisconsin
country: United States
facility: ALTANA Pharma
state: Wisconsin
city: Cities in Argentina
country: Argentina
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:
citation: Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.
citation: Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.