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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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313209
First received: April 11, 2006
Last updated: November 1, 2016
Last verified: November 2016
History of Changes
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Roflumilast
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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]
Count of Participants 		     
Female      147  31.5%      168  36.0%      315  33.8% 
Male      319  68.5%      299  64.0%      618  66.2% 


  Outcome Measures
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1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)   [ Time Frame: Change from baseline over 24 weeks of treatment ]
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2.  Secondary:   Post-bronchodilator FEV1   [ Time Frame: Change from baseline over 24 weeks of treatment ]
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3.  Secondary:   COPD Exacerbation Rate (Mild, Moderate or Severe)   [ Time Frame: 24 weeks treatment period ]
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4.  Secondary:   Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]
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5.  Secondary:   Shortness of Breath Questionnaire (SOBQ) Total Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame 24 weeks treatment period
Additional Description The Safety Set was based on all randomized patients who took at least one dose of the investigational drug after randomization.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Roflumilast   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   165/466 (35.41%)   143/467 (30.62%) 
Gastrointestinal disorders     
Diarrhoea † 1 [3]     
# participants affected / at risk   38/466 (8.15%)   15/467 (3.21%) 
# events   41   16 
Nausea † 1     
# participants affected / at risk   25/466 (5.36%)   1/467 (0.21%) 
# events   26   1 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   33/466 (7.08%)   35/467 (7.49%) 
# events   39   43 
Investigations     
Weight decreased † 1 [3]     
# participants affected / at risk   39/466 (8.37%)   5/467 (1.07%) 
# events   39   5 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1 [3]     
# participants affected / at risk   70/466 (15.02%)   103/467 (22.06%) 
# events   81   126 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)
[3] non-serious



  Limitations and Caveats
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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
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  More Information
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