Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
Interventions
DRUGbudesonide/formoterol Turbuhaler 320/9µg
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
DRUGformoterol Turbuhaler 9µg
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
OTHERPlacebo
Placebo, 1 inhalation twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>=40 years of age * diagnosed COPD with symptoms \>= 2 years * pre-bronchodilatory FEV1 \<=50% of PN
Exclusion criteria
* Current respiratory tract disorder other than COPD * history of asthma or rhinitis * significant or unstable cardiovascular disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose | Single measurement taken1 hour post-dose at the end of each 1-week treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Flow (FEV1) Pre-dose | Pre-dose at the start of treatment and pre-dose after one week of treatment | 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. |
| Forced Vital Capacity (FVC) Pre-dose | Pre-dose at the start of treatment and pre-dose after one week of treatment | 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. |
| Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) | Pre-dose at the start of treatment and pre-dose after one week of treatment | 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. |
| Peak Expiratory Flow (PEF) Before Morning Dose | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period. |
| Sleep Score | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | 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). |
| Breathlessness Score | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | 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. |
| Chest Tightness Score | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | 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). |
| Cough Score | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | 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). |
| Number of Inhalations of Reliever Medication | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period. |
| Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose | Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | 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). |
| Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose | Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to \>10 (absolute maximum breathing discomfort). |
| Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose | Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to \>10 (absolute maximum breathing discomfort). |
| Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose | Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | 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. |
| Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose | Single measurement taken 6 hours post-dose at the end of each 1-week treatment period | 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. |
| Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
| SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score | Single measurement taken at the end of each 1-week treatment period | Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data. |
| Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | Treatment means from individual participant data. |
Countries
Germany, Switzerland
Participant flow
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.)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 111 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period 3 | Study specific discontinuation criteria | 0 | 1 | 0 |
| Wash-out Period 1 | Adverse Event | 0 | 1 | 1 |
| Wash-out Period 1 | Protocol Violation | 0 | 1 | 1 |
| Wash-out Period 1 | Study-specific discontinuation criteria | 0 | 1 | 4 |
| Wash-out Period 1 | Withdrawal by Subject | 1 | 0 | 0 |
| Wash-out Period 2 | Adverse Event | 1 | 1 | 0 |
| Wash-out Period 2 | Study specific discontinuation criteria | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 63.7 Year |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 101 | 3 / 102 | 6 / 104 |
| serious Total, serious adverse events | 2 / 101 | 1 / 102 | 1 / 104 |
Outcome results
Primary
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose | 529 Seconds | Standard Deviation 377 |
| Formoterol | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose | 441 Seconds | Standard Deviation 292 |
| Placebo | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose | 406 Seconds | Standard Deviation 306 |
Secondary
Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 11.5 Scores on a scale | Standard Deviation 2.7 |
| Formoterol | Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 11.6 Scores on a scale | Standard Deviation 2.9 |
| Placebo | Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 11.4 Scores on a scale | Standard Deviation 2.9 |
Secondary
Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 11.5 Scores on a scale | Standard Deviation 2.9 |
| Formoterol | Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 11.5 Scores on a scale | Standard Deviation 3.1 |
| Placebo | Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 11.8 Scores on a scale | Standard Deviation 3.1 |
Secondary
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 3.3 Scores on a scale | Standard Deviation 3.2 |
| Formoterol | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 3.4 Scores on a scale | Standard Deviation 3.1 |
| Placebo | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose | 3.9 Scores on a scale | Standard Deviation 3.5 |
Secondary
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose | 3.6 Scores on a scale | Standard Deviation 3.2 |
| Formoterol | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose | 3.4 Scores on a scale | Standard Deviation 3.1 |
| Placebo | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose | 3.9 Scores on a scale | Standard Deviation 3.5 |
Secondary
Breathlessness Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Breathlessness Score | -0.12 Score on Scale | Standard Deviation 0.54 |
| Formoterol | Breathlessness Score | -0.40 Score on Scale | Standard Deviation 0.46 |
| Placebo | Breathlessness Score | 0.15 Score on Scale | Standard Deviation 0.49 |
Secondary
Chest Tightness Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Chest Tightness Score | -0.08 Score on a scale | Standard Deviation 0.46 |
| Formoterol | Chest Tightness Score | -0.02 Score on a scale | Standard Deviation 0.47 |
| Placebo | Chest Tightness Score | 0.17 Score on a scale | Standard Deviation 0.47 |
Secondary
Cough Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Cough Score | -0.11 Scores on a scale | Standard Deviation 0.51 |
| Formoterol | Cough Score | -0.05 Scores on a scale | Standard Deviation 0.5 |
| Placebo | Cough Score | 0.10 Scores on a scale | Standard Deviation 0.45 |
Secondary
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose | 463 Seconds | Standard Deviation 312 |
| Formoterol | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose | 408 Seconds | Standard Deviation 283 |
| Placebo | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose | 388 Seconds | Standard Deviation 306 |
Secondary
Forced Expiratory Flow (FEV1) Pre-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Forced Expiratory Flow (FEV1) Pre-dose | 0.0830 Liters | Standard Deviation 0.248 |
| Formoterol | Forced Expiratory Flow (FEV1) Pre-dose | 0.0630 Liters | Standard Deviation 0.25 |
| Placebo | Forced Expiratory Flow (FEV1) Pre-dose | -0.046 Liters | Standard Deviation 0.183 |
Secondary
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Symbicort | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 5.59 Liters | Standard Deviation 1.69 |
| Formoterol | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 5.66 Liters | Standard Deviation 1.61 |
| Placebo | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 5.79 Liters | Standard Deviation 1.64 |
Secondary
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 5.47 Liters | Standard Deviation 1.65 |
| Formoterol | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 5.49 Liters | Standard Deviation 1.45 |
| Placebo | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 5.82 Liters | Standard Deviation 1.88 |
Secondary
Forced Vital Capacity (FVC) Pre-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Forced Vital Capacity (FVC) Pre-dose | 0.060 Liters | Standard Deviation 0.406 |
| Formoterol | Forced Vital Capacity (FVC) Pre-dose | 0.067 Liters | Standard Deviation 0.407 |
| Placebo | Forced Vital Capacity (FVC) Pre-dose | -0.094 Liters | Standard Deviation 0.36 |
Secondary
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose | 2.06 Liter | Standard Deviation 0.85 |
| Formoterol | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose | 2.10 Liter | Standard Deviation 0.82 |
| Placebo | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose | 1.97 Liter | Standard Deviation 0.72 |
Secondary
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 2.12 Liters | Standard Deviation 0.79 |
| Formoterol | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 2.12 Liters | Standard Deviation 0.8 |
| Placebo | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose | 1.85 Liters | Standard Deviation 0.84 |
Secondary
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 2.19 Liters | Standard Deviation 0.61 |
| Formoterol | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 2.18 Liters | Standard Deviation 0.7 |
| Placebo | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 1.91 Liters | Standard Deviation 0.58 |
Secondary
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 2.14 Liters | Standard Deviation 0.6 |
| Formoterol | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 2.08 Liters | Standard Deviation 0.69 |
| Placebo | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 1.92 Liters | Standard Deviation 0.66 |
Secondary
Number of Inhalations of Reliever Medication
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Number of Inhalations of Reliever Medication | -0.42 Number of inhalations during 24 hours | Standard Deviation 1.51 |
| Formoterol | Number of Inhalations of Reliever Medication | -0.36 Number of inhalations during 24 hours | Standard Deviation 1.26 |
| Placebo | Number of Inhalations of Reliever Medication | 0.51 Number of inhalations during 24 hours | Standard Deviation 1.33 |
Secondary
Peak Expiratory Flow (PEF) Before Morning Dose
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Peak Expiratory Flow (PEF) Before Morning Dose | 1.30 Liters/minute | Standard Deviation 32.7 |
| Formoterol | Peak Expiratory Flow (PEF) Before Morning Dose | 5.60 Liters/minute | Standard Deviation 21.5 |
| Placebo | Peak Expiratory Flow (PEF) Before Morning Dose | -10.00 Liters/minute | Standard Deviation 27 |
Secondary
Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 4.83 Liters | Standard Deviation 1.59 |
| Formoterol | Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 4.94 Liters | Standard Deviation 1.62 |
| Placebo | Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 5.13 Liters | Standard Deviation 1.65 |
Secondary
Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 4.74 Liters | Standard Deviation 1.63 |
| Formoterol | Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 4.79 Liters | Standard Deviation 1.52 |
| Placebo | Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | 5.19 Liters | Standard Deviation 1.92 |
Secondary
SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score | 51.7 Scores on a scale | Standard Deviation 18 |
| Formoterol | SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score | 51.6 Scores on a scale | Standard Deviation 19.2 |
| Placebo | SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score | 54.5 Scores on a scale | Standard Deviation 18.9 |
Secondary
Sleep Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Sleep Score | -1.70 Score on Scale | Standard Deviation 0.47 |
| Formoterol | Sleep Score | -0.03 Score on Scale | Standard Deviation 0.47 |
| Placebo | Sleep Score | 0.11 Score on Scale | Standard Deviation 0.47 |
Secondary
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 2.90 kilopascal | Standard Deviation 1.66 |
| Formoterol | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 2.98 kilopascal | Standard Deviation 1.81 |
| Placebo | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | 4.22 kilopascal | Standard Deviation 2.29 |
Secondary
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET | 3.06 Kilopascals | Standard Deviation 1.68 |
| Formoterol | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET | 3.20 Kilopascals | Standard Deviation 2.02 |
| Placebo | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET | 4.12 Kilopascals | Standard Deviation 2.54 |
Secondary
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 7.58 Liter | Standard Deviation 1.71 |
| Formoterol | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 7.62 Liter | Standard Deviation 1.68 |
| Placebo | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 7.45 Liter | Standard Deviation 1.76 |
Secondary
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 7.41 Liters | Standard Deviation 1.68 |
| Formoterol | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 7.37 Liters | Standard Deviation 1.55 |
| Placebo | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | 7.63 Liters | Standard Deviation 2 |
Secondary
Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 2.75 Liters | Standard Deviation 0.72 |
| Formoterol | Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 2.73 Liters | Standard Deviation 0.77 |
| Placebo | Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | 2.37 Liters | Standard Deviation 0.66 |
Secondary
Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) | 2.69 Liters | Standard Deviation 0.73 |
| Formoterol | Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) | 2.64 Liters | Standard Deviation 0.78 |
| Placebo | Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) | 2.42 Liters | Standard Deviation 0.71 |
Secondary
Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) | 0.105 Liters | Standard Deviation 0.36 |
| Formoterol | Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) | 0.089 Liters | Standard Deviation 0.37 |
| Placebo | Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) | -0.083 Liters | Standard Deviation 0.371 |