Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
NCT ID: NCT00073177
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
819 participants
INTERVENTIONAL
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Roflumilast
Eligibility Criteria
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Inclusion Criteria
* No change in asthma treatment within 4 weeks prior to visit 1
* Non-smoker or ex-smoker (for 12 months or longer)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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ALTANA Pharma
Cities in Alabama, Alabama, United States
ALTANA Pharma
Cities in Arizona, Arizona, United States
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
ALTANA Pharma
Cities in California, California, United States
ALTANA Pharma
Cities in Colorado, Colorado, United States
ALTANA Pharma
Cities in Florida, Florida, United States
ALTANA Pharma
Cities in Georgia, Georgia, United States
ALTANA Pharma
Cities in Idaho, Idaho, United States
ALTANA Pharma
Cities in Illinois, Illinois, United States
ALTANA Pharma
Cities in Indiana, Indiana, United States
ALTANA Pharma
Cities in Iowa, Iowa, United States
ALTANA Pharma
Cities in Kansas, Kansas, United States
ALTANA Pharma
Cities in Kentucky, Kentucky, United States
ALTANA Pharma
Cities in Louisiana, Louisiana, United States
ALTANA Pharma
Cities in Maryland, Maryland, United States
ALTANA Pharma
Massachusetts, Massachusetts, United States
ALTANA Pharma
Cities in Michigan, Michigan, United States
ALTANA Pharma
Cities in Minnesota, Minnesota, United States
ALTANA Pharma
Cities in Mississippi, Mississippi, United States
ALTANA Pharma
Cities in Missouri, Missouri, United States
ALTANA Pharma
Cities in Montana, Montana, United States
ALTANA Pharma
Cities in Nebraska, Nebraska, United States
ALTANA Pharma
Cities in Nevada, Nevada, United States
ALTANA Pharma
Cities in New Jersey, New Jersey, United States
ALTANA Pharma
Cities in New York, New York, United States
ALTANA Pharma
Cities in North Carolina, North Carolina, United States
ALTANA Pharma
Cities in North Dakota, North Dakota, United States
ALTANA Pharma
Cities in Oregon, Oregon, United States
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania, United States
ALTANA Pharma
Cities in Rhode Island, Rhode Island, United States
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
ALTANA Pharma
Cities in Tennessee, Tennessee, United States
ALTANA Pharma
Cities in Texas, Texas, United States
ALTANA Pharma
Cities in Utah, Utah, United States
ALTANA Pharma
Cities in Virginia, Virginia, United States
ALTANA Pharma
Cities in Washington, Washington, United States
ALTANA Pharma
Cities in Wisconsin, Wisconsin, United States
ALTANA Pharma
Cities in Argentina, , Argentina
ALTANA Pharma
Cities in Colombia, , Colombia
ALTANA Pharma
Cities in Mexico, , Mexico
ALTANA Pharma
Cities in Peru, , Peru
Countries
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References
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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.
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.
Related Links
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BY217-M2-012-RDS-2007-01-02.pdf
Other Identifiers
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BY217/M2-012
Identifier Type: -
Identifier Source: org_study_id
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