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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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

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

  Show 41 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: Dirk Bredenbröker, MD ALTANA Pharma, D-78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00073177     History of Changes
Other Study ID Numbers: BY217/M2-012
Study First Received: November 17, 2003
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013