Trial · NCT01069289
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01069289, Phase 3, Completed, AstraZeneca; results first posted 2012-10-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients. Trials, record NCT01069289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01069289
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
- NCT number
- NCT01069289
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,293 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Budesonide/formoterol (Symbicort Turbuhaler), Formoterol (Oxis Turbuhaler)
- First posted
- 2010-02-17
- Last updated
- 2012-10-25
- Results first posted
- 2012-10-25
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | Pre-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | 1 Hour Post-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Secondary | Percentage of Participants With Exacerbations | Daily during 12-week randomization treatment | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group. |
| Secondary | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Daily during 12-week randomization treatment | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment |
| Secondary | Morning Peak Expiratory Flow(PEF) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Evening Peak Expiratory Flow (PEF) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
| Secondary | Total Number of Day With Exacerbation | Daily during 12-week randomization treatment | Total number of days with COPD exacerbation for each treatment group |
| Secondary | Morning Forced Expiratory Volume in One Second (FEV1) | Daily during run-in period and daily during 12-week randomization treatment | The change from Run-in period average to Treatment period average for each treatment group |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | percentage of Baseline | GEOMETRIC_MEAN |
| SECONDARY | 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | percentage of Baseline | GEOMETRIC_MEAN |
| SECONDARY | Pre-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | percentage of Baseline | GEOMETRIC_MEAN |
| SECONDARY | 1 Hour Post-dose Forced Vital Capacity (FVC) | Before randomization, 0, 4, 8 and 12 weeks after randomization | The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | percentage of Baseline | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Exacerbations | Daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | event | NUMBER |
| SECONDARY | Morning Peak Expiratory Flow(PEF) | Daily during run-in period and daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Liter/minute (L/min) | MEAN |
| SECONDARY | Evening Peak Expiratory Flow (PEF) | Daily during run-in period and daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Liter/minute (L/min) | MEAN |
| SECONDARY | Total Number of Day With Exacerbation | Daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | days | NUMBER |
| SECONDARY | Morning Forced Expiratory Volume in One Second (FEV1) | Daily during run-in period and daily during 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Liter (L) | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pre-dose Forced Expiratory Volume in One Second (FEV1) | Symbicort Turbuhaler (Experimental) | 104.6 | Full Range 37.4 to 311.1 | percentage of Baseline | |
| Pre-dose Forced Expiratory Volume in One Second (FEV1) | Oxis Turbuhaler (Active Comparator) | 101.5 | Full Range 35.1 to 218.5 | percentage of Baseline | |
| 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | Symbicort Turbuhaler (Experimental) | 113.9 | Full Range 55.5 to 336.3 | percentage of Baseline | |
| 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | Oxis Turbuhaler (Active Comparator) | 111.2 | Full Range 51.3 to 203.3 | percentage of Baseline | |
| Pre-dose Forced Vital Capacity (FVC) | Symbicort Turbuhaler (Experimental) | 102.2 | Full Range 57.3 to 313.8 | percentage of Baseline | |
| Pre-dose Forced Vital Capacity (FVC) | Oxis Turbuhaler (Active Comparator) | 100.9 | Full Range 61.5 to 347.6 | percentage of Baseline | |
| 1 Hour Post-dose Forced Vital Capacity (FVC) | Symbicort Turbuhaler (Experimental) | 110.1 | Full Range 62.0 to 262.7 | percentage of Baseline | |
| 1 Hour Post-dose Forced Vital Capacity (FVC) | Oxis Turbuhaler (Active Comparator) | 108.7 | Full Range 63.5 to 272.7 | percentage of Baseline | |
| Percentage of Participants With Exacerbations | Symbicort Turbuhaler (Experimental) | 11.9 | percentage of participants | ||
| Percentage of Participants With Exacerbations | Oxis Turbuhaler (Active Comparator) | 16.9 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Symbicort Turbuhaler (Experimental) | 636 | |
| Overall Study | STARTED | Oxis Turbuhaler (Active Comparator) | 657 | |
| Overall Study | COMPLETED | Symbicort Turbuhaler (Experimental) | 594 | |
| Overall Study | COMPLETED | Oxis Turbuhaler (Active Comparator) | 601 | |
| Overall Study | NOT COMPLETED | Symbicort Turbuhaler (Experimental) | 42 | |
| Overall Study | NOT COMPLETED | Oxis Turbuhaler (Active Comparator) | 56 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Symbicort Turbuhaler (Experimental) | 35 | 636 | |
| other | Nasopharyngitis | Infections and infestations | Oxis Turbuhaler (Active Comparator) | 32 | 657 | |
| other | Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Symbicort Turbuhaler (Experimental) | 29 | 636 | |
| other | Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Oxis Turbuhaler (Active Comparator) | 36 | 657 | |
| serious | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | Symbicort Turbuhaler (Experimental) | 24 | 636 | |
| serious | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | Oxis Turbuhaler (Active Comparator) | 28 | 657 | |
| serious | PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Symbicort Turbuhaler (Experimental) | 1 | 636 | |
| serious | PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Oxis Turbuhaler (Active Comparator) | 2 | 657 | |
| serious | ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Symbicort Turbuhaler (Experimental) | 1 | 636 | |
| serious | ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Oxis Turbuhaler (Active Comparator) | 0 | 657 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Symbicort Turbuhaler (Experimental) | ||
| Total, all-cause mortality | Oxis Turbuhaler (Active Comparator) | ||
| Total, other adverse events | Symbicort Turbuhaler (Experimental) | 61 | 636 |
| Total, other adverse events | Oxis Turbuhaler (Active Comparator) | 66 | 657 |
| Total, serious adverse events | Symbicort Turbuhaler (Experimental) | 43 | 636 |
| Total, serious adverse events | Oxis Turbuhaler (Active Comparator) | 45 | 657 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Symbicort Turbuhaler (Experimental) vs Oxis Turbuhaler (Active Comparator): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01069289
GET https://conductscience.org/api/trials/v1/NCT01069289/results?page=2