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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)

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.
ClinicalTrials.gov Identifier: NCT00313209
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : May 19, 2011
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Roflumilast
Drug: Placebo

  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

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]
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

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

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  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Net) [5] 49
95% Confidence Interval 27 to 71
Standard Error of the mean (11)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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).
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Post-bronchodilator FEV1
Measure Description Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time Frame Change from baseline over 24 weeks of treatment  

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 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 
Participants Analyzed 
[Units: Participants]
 452   460 
Post-bronchodilator FEV1 
[Units: mL]
Least Squares Mean (Standard Error)
 68  (9)   8  (9) 


Statistical Analysis 1 for Post-bronchodilator FEV1
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Net) [5] 60
95% Confidence Interval 38 to 82
Standard Error of the mean (11)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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).
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title COPD Exacerbation Rate (Mild, Moderate or Severe)
Measure Description Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005].
Time Frame 24 weeks treatment period  

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 analysis

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 
Participants Analyzed 
[Units: Participants]
 466   467 
COPD Exacerbation Rate (Mild, Moderate or Severe) 
[Units: Exacerbations per patient per year]
Mean (95% Confidence Interval)
 1.9 
 (1.5 to 2.5) 
 2.4 
 (1.9 to 3.1) 


Statistical Analysis 1 for COPD Exacerbation Rate (Mild, Moderate or Severe)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Poisson regression
P Value [4] 0.1408
Rate ratio [5] 0.79
95% Confidence Interval 0.58 to 1.08
Standard Error of the mean (0.12)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Transition Dyspnea Index (TDI) Focal Score
Measure Description The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.
Time Frame Change from baseline over 24 weeks of treatment  

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 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 
Participants Analyzed 
[Units: Participants]
 454   460 
Transition Dyspnea Index (TDI) Focal Score 
[Units: Scores on a scale]
Least Squares Mean (Standard Error)
 1.2  (0.1)   1.1  (0.1) 


Statistical Analysis 1 for Transition Dyspnea Index (TDI) Focal Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.4654
Mean Difference (Final Values) [5] 0.1
95% Confidence Interval -0.2 to 0.4
Standard Error of the mean (0.2)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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).
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Shortness of Breath Questionnaire (SOBQ) Total Score
Measure Description Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".
Time Frame Change from baseline over 24 weeks of treatment  

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 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 
Participants Analyzed 
[Units: Participants]
 454   461 
Shortness of Breath Questionnaire (SOBQ) Total Score 
[Units: Scores on a scale]
Least Squares Mean (Standard Error)
 -0.6  (0.7)   -1.1  (0.7) 


Statistical Analysis 1 for Shortness of Breath Questionnaire (SOBQ) Total Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.5457
Mean Difference (Net) [5] 0.5
95% Confidence Interval -1.2 to 2.2
Standard Error of the mean (0.9)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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).
[4] 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.
[5] Other relevant estimation information:
  No text entered.




  Serious Adverse Events

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.

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

Serious Adverse Events
    Roflumilast   Placebo
Total, Serious Adverse Events     
# participants affected / at risk   36/466 (7.73%)   42/467 (8.99%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Cardiac disorders     
Myocardial infarction † 1     
# participants affected / at risk   2/466 (0.43%)   1/467 (0.21%) 
# events   2   1 
Atrial fibrillation † 1     
# participants affected / at risk   2/466 (0.43%)   0/467 (0.00%) 
# events   2   0 
Cardiac failure † 1     
# participants affected / at risk   0/466 (0.00%)   2/467 (0.43%) 
# events   0   2 
Acute myocardial infarction † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Angina pectoris † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Atrioventricular block complete † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Cardiac failure congestive † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Tachycardia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Congenital, familial and genetic disorders     
Retinitis pigmentosa † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Ear and labyrinth disorders     
Tympanic membrane perforation † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Vertigo † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Gastrointestinal disorders     
Crohn's disease † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Diarrhoea † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Haematemesis † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Oesophageal varices haemorrhage † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Peptic ulcer perforation † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
General disorders     
Asthenia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
General physical health deterioration † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Hyperthermia † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Nodule † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Pyrexia † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Infections and infestations     
Pneumonia † 1     
# participants affected / at risk   1/466 (0.21%)   2/467 (0.43%) 
# events   1   2 
Abdominal abscess † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Bronchopneumonia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Cellulitis † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Gastroenteritis † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Lobar pneumonia † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Tooth abscess † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Urinary tract infection † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Fracture † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Injury † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Radius fracture † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Investigations     
Investigation † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Weight decreased † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer † 1     
# participants affected / at risk   1/466 (0.21%)   2/467 (0.43%) 
# events   1   2 
Colon cancer † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Fibroadenoma of breast † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Gastric cancer † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Pancreatic carcinoma metastatic † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Papillary thyroid cancer † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Renal neoplasm † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Small cell lung cancer stage unspecified † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Squamous cell carcinoma † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Nervous system disorders     
Carotid artery stenosis † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Cerebrovascular accident † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Loss of consciousness † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Meningorrhagia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Psychiatric disorders     
Mental disorder † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Suicide attempt † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Renal and urinary disorders     
Renal failure acute † 1     
# participants affected / at risk   1/466 (0.21%)   2/467 (0.43%) 
# events   1   2 
Renal failure † 1     
# participants affected / at risk   0/466 (0.00%)   2/467 (0.43%) 
# events   0   2 
Dysuria † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Urinary tract obstruction † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   7/466 (1.50%)   11/467 (2.36%) 
# events   7   11 
Acute respiratory failure † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Bronchospasm † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Foreign body aspiration † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Pleural effusion † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Skin and subcutaneous tissue disorders     
Rash papular † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Skin lesion † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Surgical and medical procedures     
Finger amputation † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Vascular disorders     
Aortic aneurysm † 1     
# participants affected / at risk   2/466 (0.43%)   1/467 (0.21%) 
# events   2   1 
Intermittent claudication † 1     
# participants affected / at risk   1/466 (0.21%)   1/467 (0.21%) 
# events   1   1 
Arterial occlusive disease † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Arterial restenosis † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Hypertension † 1     
# participants affected / at risk   0/466 (0.00%)   1/467 (0.21%) 
# events   0   1 
Peripheral ischaemia † 1     
# participants affected / at risk   1/466 (0.21%)   0/467 (0.00%) 
# events   1   0 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)




  Other Adverse Events


  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

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: AstraZeneca Clinical Study Information Center
Organization: AstraZeneca
phone: 1-877-240-9479
e-mail: information.center@astrazeneca.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313209     History of Changes
Other Study ID Numbers: BY217/M2-127
2005-005080-28 ( EudraCT Number )
First Submitted: April 11, 2006
First Posted: April 12, 2006
Results First Submitted: March 17, 2011
Results First Posted: May 19, 2011
Last Update Posted: December 14, 2016