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Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

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: NCT00163527
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE April 2003
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
change in forced expiratory volume in 1 second from baseline to final visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00163527 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
  • change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
  • number of rescue free/symptom free days based on the diary card
  • area under the curves over the full 24-week trial period for the diary variables
  • number of exacerbations
  • time to first exacerbation
  • change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
Official Title  ICMJE A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
Brief Summary

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Roflumilast
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • Written informed consent
  • Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
  • The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
  • FEV1 between 60 and 90% predicted at visit 1
  • No change in asthma treatment within 4 weeks prior to visit 1

Main Exclusion Criteria:

  • Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
  • Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
  • A history of lower airway infection in the four weeks prior to visit 1
  • A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
  • Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
  • Patients using >8 puffs/day relief medication regularly prior to visit 1
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
  • Patients with chronic heart failure class III or IV (New York Heart Association)
  • Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
  • A history of alcoholism or substance abuse within the 12 months prior to visit 1
  • Pregnancy or women of childbearing potential who are not using a reliable method of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Croatia,   Czech Republic,   Finland,   France,   Greece,   Hungary,   India,   Ireland,   Italy,   New Zealand,   Norway,   Pakistan,   Philippines,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00163527
Other Study ID Numbers  ICMJE BY217/M2-013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: AstraZeneca AstraZeneca AstraZeneca
PRS Account AstraZeneca
Verification Date September 2016

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