Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00313209
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: April 2011
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Roflumilast
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
Placebo Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled

Participant Flow:   Overall Study
    Roflumilast     Placebo  
STARTED     466 [1]   467 [1]
COMPLETED     359     385  
NOT COMPLETED     107     82  
[1] Includes all randomized patients who took at least one dose of the investigational drug.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
Placebo Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
Total Total of all reporting groups

Baseline Measures
    Roflumilast     Placebo     Total  
Number of Participants  
[units: participants]
  466     467     933  
Age  
[units: years]
Mean ± Standard Deviation
  64.9  ± 8.7     64.9  ± 9.3     64.9  ± 9.0  
Gender  
[units: participants]
     
Female     147     168     315  
Male     319     299     618  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)   [ Time Frame: Change from baseline over 24 weeks of treatment ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Measure Description Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Time Frame Change from baseline over 24 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
Placebo Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled

Measured Values
    Roflumilast     Placebo  
Number of Participants Analyzed  
[units: participants]
  456     463  
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)  
[units: mL]
Least Squares Mean ± Standard Error
  39  ± 9     -10  ± 9  


Statistical Analysis 1 for Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Net) [4] 49
Standard Error of the mean ± 11
95% Confidence Interval ( 27 to 71 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Post-bronchodilator FEV1   [ Time Frame: Change from baseline over 24 weeks of treatment ]

3.  Secondary:   COPD Exacerbation Rate (Mild, Moderate or Severe)   [ Time Frame: 24 weeks treatment period ]

4.  Secondary:   Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]

5.  Secondary:   Shortness of Breath Questionnaire (SOBQ) Total Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Respiratory Medical Advisor
Organization: Nycomed GmbH
phone: 0049-7531-840
e-mail: clinicaltrials@nycomed.com


No publications provided by Takeda

Publications automatically indexed to this study:

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00313209     History of Changes
Other Study ID Numbers: BY217/M2-127, 2005-005080-28
Study First Received: April 11, 2006
Results First Received: March 17, 2011
Last Updated: May 4, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency