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Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
This study has been completed.
First Received: November 17, 2003   Last Updated: April 2, 2007   History of Changes
Sponsor: ALTANA Pharma
Information provided by: ALTANA Pharma
ClinicalTrials.gov Identifier: NCT00073177
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Roflumilast
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by ALTANA Pharma:

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

Secondary Outcome Measures:
  • pulmonary function variables
  • diary variables
  • quality of life variables
  • time to first exacerbation
  • number of asthma exacerbations
  • safety.

Estimated Enrollment: 819
Study Start Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073177

  Hide Study Locations
Locations
United States, Alabama
ALTANA Pharma
Cities in Alabama, Alabama, United States
United States, Arizona
ALTANA Pharma
Cities in Arizona, Arizona, United States
United States, Arkansas
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
United States, California
ALTANA Pharma
Cities in California, California, United States
United States, Colorado
ALTANA Pharma
Cities in Colorado, Colorado, United States
United States, Florida
ALTANA Pharma
Cities in Florida, Florida, United States
United States, Georgia
ALTANA Pharma
Cities in Georgia, Georgia, United States
United States, Idaho
ALTANA Pharma
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
ALTANA Pharma
Cities in Montana, Montana, United States
United States, Nebraska
ALTANA Pharma
Cities in Nebraska, Nebraska, United States
United States, Nevada
ALTANA Pharma
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
ALTANA Pharma
Cities in Rhode Island, Rhode Island, United States
United States, South Carolina
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
United States, Tennessee
ALTANA Pharma
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
ALTANA Pharma
Investigators
Study Director: Dirk Bredenbröker, MD ALTANA Pharma, D-78467 Konstanz, Germany
  More Information

No publications provided

Study ID Numbers: BY217/M2-012
Study First Received: November 17, 2003
Last Updated: April 2, 2007
ClinicalTrials.gov Identifier: NCT00073177     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009