Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
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
1 other identifier
interventional
819
5 countries
41
Brief Summary
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 17, 2003
CompletedFirst Posted
Study publicly available on registry
November 19, 2003
CompletedOctober 25, 2016
September 1, 2016
November 17, 2003
October 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change in lung function from baseline to final visit.
Secondary Outcomes (6)
pulmonary function variables
diary variables
quality of life variables
time to first exacerbation
number of asthma exacerbations
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
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
Related Publications (2)
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.
PMID: 26612545DERIVEDMeltzer 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.
PMID: 26498386DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2003
First Posted
November 19, 2003
Study Start
November 1, 2003
Last Updated
October 25, 2016
Record last verified: 2016-09