Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD (CODEX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00489853
First received: June 19, 2007
Last updated: July 27, 2012
Last verified: July 2012
Results First Received: August 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: budesonide/formoterol Turbuhaler 320/9µg
Drug: formoterol Turbuhaler 9µg
Other: 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
Patients were recruited in 12 centers in Germany and 12 centers in Switzerland.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among 137 enrolled patients, 26 patients were not randomised (14 due to violation of inclusion/exclusion criteria, 2 due to adverse events, 1 due to development of study-specific discontinuation criteria, 7 due to voluntary discontinuation, 1 due to lost to follow-up, and 1 due to other reason.)

Reporting Groups
  Description
Symbicort Then Formoterol Then Placebo Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
Formoterol Then Symbicort Then Placebo Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
Placebo Then Formoterol Then Symbicort Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily

Participant Flow for 6 periods

Period 1:   Treatment Period 1
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     36     37     38  
COMPLETED     36     37     38  
NOT COMPLETED     0     0     0  

Period 2:   Wash-out Period 1
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     36     37     38  
COMPLETED     35     34     32  
NOT COMPLETED     1     3     6  
Withdrawal by Subject                 1                 0                 0  
Adverse Event                 0                 1                 1  
Protocol Violation                 0                 1                 1  
Study-specific discontinuation criteria                 0                 1                 4  

Period 3:   Treatment Period 2
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     33     35     33  
COMPLETED     33     35     33  
NOT COMPLETED     0     0     0  

Period 4:   Wash-out Period 2
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     33     35     33  
COMPLETED     29     32     31  
NOT COMPLETED     4     3     2  
Adverse Event                 1                 1                 0  
Study specific discontinuation criteria                 3                 2                 2  

Period 5:   Treatment Period 3
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     29     30     33  
COMPLETED     29     29     33  
NOT COMPLETED     0     1     0  
Study specific discontinuation criteria                 0                 1                 0  

Period 6:   Follow-up Period
    Symbicort Then Formoterol Then Placebo     Formoterol Then Symbicort Then Placebo     Placebo Then Formoterol Then Symbicort  
STARTED     29     29     33  
COMPLETED     29     29     33  
NOT COMPLETED     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Entire Study Population Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  111  
Age  
[units: Year]
Mean ( Full Range )
  63.7  
  ( 42 to 83 )  
Gender  
[units: Participants]
 
Female     27  
Male     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose   [ Time Frame: Single measurement taken1 hour post-dose at the end of each 1-week treatment period ]

2.  Secondary:   Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose   [ Time Frame: Single measurement taken 6 hours post-dose at the end of each 1-week treatment period ]

3.  Secondary:   Forced Expiratory Flow (FEV1) Pre-dose   [ Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment ]

4.  Secondary:   Forced Vital Capacity (FVC) Pre-dose   [ Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment ]

5.  Secondary:   Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)   [ Time Frame: Pre-dose at the start of treatment and pre-dose after one week of treatment ]

6.  Secondary:   Peak Expiratory Flow (PEF) Before Morning Dose   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

7.  Secondary:   Sleep Score   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

8.  Secondary:   Breathlessness Score   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

9.  Secondary:   Chest Tightness Score   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

10.  Secondary:   Cough Score   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

11.  Secondary:   Number of Inhalations of Reliever Medication   [ Time Frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period ]

12.  Secondary:   Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose   [ Time Frame: Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

13.  Secondary:   Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose   [ Time Frame: Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

14.  Secondary:   Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose   [ Time Frame: Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

15.  Secondary:   Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose   [ Time Frame: Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

16.  Secondary:   Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

17.  Secondary:   Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

18.  Secondary:   Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

19.  Secondary:   Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period ]

20.  Secondary:   Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

21.  Secondary:   Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

22.  Secondary:   Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

23.  Secondary:   Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period ]

24.  Secondary:   Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

25.  Secondary:   Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

26.  Secondary:   Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

27.  Secondary:   Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period ]

28.  Secondary:   Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

29.  Secondary:   Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET   [ Time Frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period ]

30.  Secondary:   SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score   [ Time Frame: Single measurement taken at the end of each 1-week treatment period ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information
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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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00489853     History of Changes
Other Study ID Numbers: D5892C00014, Eudract No: 2006-006519-60
Study First Received: June 19, 2007
Results First Received: August 6, 2009
Last Updated: July 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic