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

November 17, 2003
April 2, 2007
November 2003
 
change in lung function from baseline to final visit.
Same as current
Complete list of historical versions of study NCT00073177 on ClinicalTrials.gov Archive Site
  • pulmonary function variables
  • diary variables
  • quality of life variables
  • time to first exacerbation
  • number of asthma exacerbations
  • safety.
Same as current
 
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

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

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Asthma
Drug: Roflumilast
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
819
 
 

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Colombia,   Mexico,   Peru
 
NCT00073177
 
BY217/M2-012
ALTANA Pharma
 
Study Director: Dirk Bredenbröker, MD ALTANA Pharma, D-78467 Konstanz, Germany
ALTANA Pharma
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP