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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. Identifier: NCT00073177
Recruitment Status : Completed
First Posted : November 19, 2003
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):

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

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 identifier (NCT number): NCT00073177

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Sponsors and Collaborators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00073177     History of Changes
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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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases