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

History of Changes

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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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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

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 ]

Show Outcome Measure 10

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 ]

Show Outcome Measure 11

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 ]

Show Outcome Measure 12

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 ]

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

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 ]

Show Outcome Measure 15

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 ]

Show Outcome Measure 16

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 ]

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

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 ]

Show Outcome Measure 19

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 ]

Show Outcome Measure 20

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 ]

Show Outcome Measure 21

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 ]

Show Outcome Measure 22

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 ]

Show Outcome Measure 23

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 ]

Show Outcome Measure 24

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 ]

Show Outcome Measure 25

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 ]

Show Outcome Measure 26

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 ]

Show Outcome Measure 27

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 ]

Show Outcome Measure 28

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 ]

Show Outcome Measure 29

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 ]

Show Outcome Measure 30

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Prior to any publication or disclosure, the PI provides AstraZeneca with preliminary data and drafts and with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript to review it and may within such time frame require that submission for publication or disclosure be delayed.

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.

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

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