Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00489853
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: budesonide/formoterol Turbuhaler 320/9µg
Drug: formoterol Turbuhaler 9µg
Other: Placebo
Enrollment 137
Recruitment Details Patients were recruited in 12 centers in Germany and 12 centers in Switzerland.
Pre-assignment Details 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.)
Arm/Group Title Symbicort Then Formoterol Then Placebo Formoterol Then Symbicort Then Placebo Placebo Then Formoterol Then Symbicort
Hide Arm/Group Description 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 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, 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
Period Title: Treatment Period 1
Started 36 37 38
Completed 36 37 38
Not Completed 0 0 0
Period Title: Wash-out Period 1
Started 36 37 38
Completed 35 34 32
Not Completed 1 3 6
Reason Not Completed
Withdrawal by Subject             1             0             0
Adverse Event             0             1             1
Protocol Violation             0             1             1
Study-specific discontinuation criteria             0             1             4
Period Title: Treatment Period 2
Started 33 35 33
Completed 33 35 33
Not Completed 0 0 0
Period Title: Wash-out Period 2
Started 33 35 33
Completed 29 32 31
Not Completed 4 3 2
Reason Not Completed
Adverse Event             1             1             0
Study specific discontinuation criteria             3             2             2
Period Title: Treatment Period 3
Started 29 30 33
Completed 29 29 33
Not Completed 0 1 0
Reason Not Completed
Study specific discontinuation criteria             0             1             0
Period Title: Follow-up Period
Started 29 29 33
Completed 29 29 33
Not Completed 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description 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
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Year
Number Analyzed 111 participants
63.7
(42 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
27
  24.3%
Male
84
  75.7%
1.Primary Outcome
Title Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
Hide Description Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Time Frame Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 98 99
Mean (Standard Deviation)
Unit of Measure: Seconds
529  (377) 441  (292) 406  (306)
2.Secondary Outcome
Title Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
Hide Description Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Time Frame Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 98 98
Mean (Standard Deviation)
Unit of Measure: Seconds
463  (312) 408  (283) 388  (306)
3.Secondary Outcome
Title Forced Expiratory Flow (FEV1) Pre-dose
Hide Description The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Time Frame Pre-dose at the start of treatment and pre-dose after one week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 101
Mean (Standard Deviation)
Unit of Measure: Liters
0.0830  (0.2480) 0.0630  (0.2500) -0.046  (0.1830)
4.Secondary Outcome
Title Forced Vital Capacity (FVC) Pre-dose
Hide Description The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Time Frame Pre-dose at the start of treatment and pre-dose after one week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 101
Mean (Standard Deviation)
Unit of Measure: Liters
0.060  (0.406) 0.067  (0.407) -0.094  (0.360)
5.Secondary Outcome
Title Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
Hide Description The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Time Frame Pre-dose at the start of treatment and pre-dose after one week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 101
Mean (Standard Deviation)
Unit of Measure: Liters
0.105  (0.3600) 0.089  (0.370) -0.083  (0.371)
6.Secondary Outcome
Title Peak Expiratory Flow (PEF) Before Morning Dose
Hide Description The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 97 98 100
Mean (Standard Deviation)
Unit of Measure: Liters/minute
1.30  (32.70) 5.60  (21.50) -10.00  (27.00)
7.Secondary Outcome
Title Sleep Score
Hide Description The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 98 99 101
Mean (Standard Deviation)
Unit of Measure: Score on Scale
-1.70  (0.47) -0.03  (0.47) 0.11  (0.47)
8.Secondary Outcome
Title Breathlessness Score
Hide Description The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 98 99 101
Mean (Standard Deviation)
Unit of Measure: Score on Scale
-0.12  (0.54) -0.40  (0.46) 0.15  (0.49)
9.Secondary Outcome
Title Chest Tightness Score
Hide Description The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 98 99 101
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.08  (0.46) -0.02  (0.47) 0.17  (0.47)
10.Secondary Outcome
Title Cough Score
Hide Description The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 98 99 101
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.11  (0.51) -0.05  (0.50) 0.10  (0.45)
11.Secondary Outcome
Title Number of Inhalations of Reliever Medication
Hide Description The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.
Time Frame Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 97 99 101
Mean (Standard Deviation)
Unit of Measure: Number of inhalations during 24 hours
-0.42  (1.51) -0.36  (1.26) 0.51  (1.33)
12.Secondary Outcome
Title Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Hide Description The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 98 98
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.3  (3.2) 3.4  (3.1) 3.9  (3.5)
13.Secondary Outcome
Title Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Hide Description The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
Time Frame Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 98 97
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
11.5  (2.7) 11.6  (2.9) 11.4  (2.9)
14.Secondary Outcome
Title Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
Hide Description The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 98 98
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.6  (3.2) 3.4  (3.1) 3.9  (3.5)
15.Secondary Outcome
Title Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Hide Description The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.
Time Frame Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 94 98 96
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
11.5  (2.9) 11.5  (3.1) 11.8  (3.1)
16.Secondary Outcome
Title Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 72 78 70
Mean (Standard Deviation)
Unit of Measure: Liter
2.06  (0.85) 2.10  (0.82) 1.97  (0.72)
17.Secondary Outcome
Title Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 71 78 76
Mean (Standard Deviation)
Unit of Measure: Liters
2.12  (0.79) 2.12  (0.80) 1.85  (0.84)
18.Secondary Outcome
Title Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 99 102
Mean (Standard Deviation)
Unit of Measure: Liters
2.75  (0.72) 2.73  (0.77) 2.37  (0.66)
19.Secondary Outcome
Title Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 99 102
Mean (Standard Deviation)
Unit of Measure: Liters
2.19  (0.61) 2.18  (0.70) 1.91  (0.58)
20.Secondary Outcome
Title Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 99 102
Median (Standard Deviation)
Unit of Measure: Liters
5.59  (1.69) 5.66  (1.61) 5.79  (1.64)
21.Secondary Outcome
Title Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 102
Mean (Standard Deviation)
Unit of Measure: Liters
4.83  (1.59) 4.94  (1.62) 5.13  (1.65)
22.Secondary Outcome
Title Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 99 102
Mean (Standard Deviation)
Unit of Measure: Liter
7.58  (1.71) 7.62  (1.68) 7.45  (1.76)
23.Secondary Outcome
Title Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 96 99 101
Mean (Standard Deviation)
Unit of Measure: kilopascal
2.90  (1.66) 2.98  (1.81) 4.22  (2.29)
24.Secondary Outcome
Title Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 100
Mean (Standard Deviation)
Unit of Measure: Liters
2.69  (0.730) 2.64  (0.78) 2.42  (0.71)
25.Secondary Outcome
Title Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 100
Mean (Standard Deviation)
Unit of Measure: Liters
2.14  (0.60) 2.08  (0.69) 1.92  (0.66)
26.Secondary Outcome
Title Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 94 99 99
Mean (Standard Deviation)
Unit of Measure: Liters
5.47  (1.65) 5.49  (1.45) 5.82  (1.88)
27.Secondary Outcome
Title Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 94 99 99
Mean (Standard Deviation)
Unit of Measure: Liters
4.74  (1.63) 4.79  (1.52) 5.19  (1.92)
28.Secondary Outcome
Title Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 94 99 100
Mean (Standard Deviation)
Unit of Measure: Liters
7.41  (1.68) 7.37  (1.55) 7.63  (2.00)
29.Secondary Outcome
Title Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
Hide Description Treatment means from individual participant data.
Time Frame Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 95 99 100
Mean (Standard Deviation)
Unit of Measure: Kilopascals
3.06  (1.68) 3.20  (2.02) 4.12  (2.54)
30.Secondary Outcome
Title SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
Hide Description Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.
Time Frame Single measurement taken at the end of each 1-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description:
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placebo, 1 inhalation twice daily
Overall Number of Participants Analyzed 85 93 91
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
51.7  (18) 51.6  (19.2) 54.5  (18.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Formoterol Placebo
Hide Arm/Group Description Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Placebo, 1 inhalation twice daily
All-Cause Mortality
Symbicort Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/101 (1.98%)   1/102 (0.98%)   1/104 (0.96%) 
Injury, poisoning and procedural complications       
Wrist Fracture  1  1/101 (0.99%)  0/102 (0.00%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  1/101 (0.99%)  1/102 (0.98%)  1/104 (0.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Formoterol Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/101 (3.96%)   3/102 (2.94%)   6/104 (5.77%) 
Respiratory, thoracic and mediastinal disorders       
Chonic Obstructive Pulmonary Disease * 1  4/101 (3.96%)  3/102 (2.94%)  6/104 (5.77%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00489853     History of Changes
Other Study ID Numbers: D5892C00014
Eudract No: 2006-006519-60
First Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: August 6, 2009
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012