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Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073177
Recruitment Status : Completed
First Posted : November 19, 2003
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Roflumilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast




Primary Outcome Measures :
  1. change in lung function from baseline to final visit.

Secondary Outcome Measures :
  1. pulmonary function variables
  2. diary variables
  3. quality of life variables
  4. time to first exacerbation
  5. number of asthma exacerbations
  6. safety.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073177


Locations
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United States, Alabama
ALTANA Pharma
Cities in Alabama, Alabama, United States
United States, Arizona
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Cities in Arizona, Arizona, United States
United States, Arkansas
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Cities in Arkansas, Arkansas, United States
United States, California
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Cities in California, California, United States
United States, Colorado
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Cities in Colorado, Colorado, United States
United States, Florida
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Cities in Florida, Florida, United States
United States, Georgia
ALTANA Pharma
Cities in Georgia, Georgia, United States
United States, Idaho
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Cities in Idaho, Idaho, United States
United States, Illinois
ALTANA Pharma
Cities in Illinois, Illinois, United States
United States, Indiana
ALTANA Pharma
Cities in Indiana, Indiana, United States
United States, Iowa
ALTANA Pharma
Cities in Iowa, Iowa, United States
United States, Kansas
ALTANA Pharma
Cities in Kansas, Kansas, United States
United States, Kentucky
ALTANA Pharma
Cities in Kentucky, Kentucky, United States
United States, Louisiana
ALTANA Pharma
Cities in Louisiana, Louisiana, United States
United States, Maryland
ALTANA Pharma
Cities in Maryland, Maryland, United States
United States, Massachusetts
ALTANA Pharma
Massachusetts, Massachusetts, United States
United States, Michigan
ALTANA Pharma
Cities in Michigan, Michigan, United States
United States, Minnesota
ALTANA Pharma
Cities in Minnesota, Minnesota, United States
United States, Mississippi
ALTANA Pharma
Cities in Mississippi, Mississippi, United States
United States, Missouri
ALTANA Pharma
Cities in Missouri, Missouri, United States
United States, Montana
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Cities in Montana, Montana, United States
United States, Nebraska
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Cities in Nebraska, Nebraska, United States
United States, Nevada
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Cities in Nevada, Nevada, United States
United States, New Jersey
ALTANA Pharma
Cities in New Jersey, New Jersey, United States
United States, New York
ALTANA Pharma
Cities in New York, New York, United States
United States, North Carolina
ALTANA Pharma
Cities in North Carolina, North Carolina, United States
United States, North Dakota
ALTANA Pharma
Cities in North Dakota, North Dakota, United States
United States, Oregon
ALTANA Pharma
Cities in Oregon, Oregon, United States
United States, Pennsylvania
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania, United States
United States, Rhode Island
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Cities in Rhode Island, Rhode Island, United States
United States, South Carolina
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Cities in South Carolina, South Carolina, United States
United States, Tennessee
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Cities in Tennessee, Tennessee, United States
United States, Texas
ALTANA Pharma
Cities in Texas, Texas, United States
United States, Utah
ALTANA Pharma
Cities in Utah, Utah, United States
United States, Virginia
ALTANA Pharma
Cities in Virginia, Virginia, United States
United States, Washington
ALTANA Pharma
Cities in Washington, Washington, United States
United States, Wisconsin
ALTANA Pharma
Cities in Wisconsin, Wisconsin, United States
Argentina
ALTANA Pharma
Cities in Argentina, Argentina
Colombia
ALTANA Pharma
Cities in Colombia, Colombia
Mexico
ALTANA Pharma
Cities in Mexico, Mexico
Peru
ALTANA Pharma
Cities in Peru, Peru
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00073177    
Other Study ID Numbers: BY217/M2-012
First Posted: November 19, 2003    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases