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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00073177
First received: November 17, 2003
Last updated: May 4, 2012
Last verified: January 2012
History of Changes

November 17, 2003
May 4, 2012
November 2003
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change in lung function from baseline to final visit.
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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.
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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.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: Roflumilast
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
819
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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
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Takeda Global Research & Development Center, Inc.
Takeda Global Research & Development Center, Inc.
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Study Director: Dirk Bredenbröker, MD ALTANA Pharma, D-78467 Konstanz, Germany
Takeda Global Research & Development Center, Inc.
January 2012

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