| 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. | | Posted | | Mean | Standard Deviation | Seconds | | Single measurement taken1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG000529± 377
- OG001441± 292
- OG002406± 306
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| 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. | | Posted | | Mean | Standard Deviation | Seconds | | Single measurement taken 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose at the start of treatment and pre-dose after one week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose at the start of treatment and pre-dose after one week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose at the start of treatment and pre-dose after one week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Liters/minute | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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). | | Posted | | Mean | Standard Deviation | Score on Scale | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Score on Scale | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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). | | Posted | | Mean | Standard Deviation | Score on a scale | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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). | | Posted | | Mean | Standard Deviation | Scores on a scale | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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. | | Posted | | Mean | Standard Deviation | Number of inhalations during 24 hours | | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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). | | Posted | | Mean | Standard Deviation | Scores on a scale | | Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| 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). | | Posted | | Mean | Standard Deviation | Scores on a scale | | Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| 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). | | Posted | | Mean | Standard Deviation | Scores on a scale | | Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| 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. | | Posted | | Mean | Standard Deviation | Scores on a scale | | Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liter | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Median | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| Secondary | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liter | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | kilopascal | | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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| Secondary | Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Liters | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| Secondary | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET | Treatment means from individual participant data. | | Posted | | Mean | Standard Deviation | Kilopascals | | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
| |
| 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. | | Posted | | Mean | Standard Deviation | Scores on a scale | | Single measurement taken at the end of each 1-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | | OG001 | Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | | OG002 | Placebo | Placebo, 1 inhalation twice daily |
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