Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

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 
Overall Participants Analyzed 
[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 ]

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