Trial · NCT02224157
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
NCT02224157, Phase 3, Completed, AstraZeneca; results first posted 2019-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. Trials, record NCT02224157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224157
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
- NCT number
- NCT02224157
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,215 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- budesonide/formoterol 'as needed' + budesonide placebo bid, budesonode bid + terbutaline 'as needed'
- First posted
- 2014-08-25
- Last updated
- 2019-11-25
- Other registries' IDs
- eudract:2013-004473-28
- Results first posted
- 2019-11-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis | up to 52 weeks | Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation |
| Primary | Annual Severe Asthma Exacerbation Rate - Superiority Analysis | up to 52 weeks | Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation |
| Secondary | Number of Participants Experiencing at Least One Severe Asthma Exacerbation | Day 1 up to 52 weeks | A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids. |
| Secondary | Average Change From Baseline in Pre-bronchodilator FEV1 | Study weeks 0,17, 34, 52 | The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis. |
| Secondary | Number of Participants With Study Specific Asthma Related Discontinuation | Day 1 up to 52 weeks | The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months. |
| Secondary | Average Change From Baseline in 'as Needed' Use | Week 0 up to 52 weeks | 'As-needed' use change from baseline over the randomised treatment period. Baseline was defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day. |
| Secondary | Change From Baseline in Percent of 'as Needed' Free Days | Week 0 up to 52 weeks | 'As needed' free days (%) change from baseline during randomised treatment period. An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication. Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period. Baseline is defined by the last 10 days of the run-in period. |
| Secondary | Percentage of Controller Use Days | Week 0 up to 52 weeks | ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period. |
| Secondary | Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score | Study weeks 0, 17, 34, 52 | ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis. |
| Secondary | Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score | Study weeks 0,17, 34, 52 | AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis | up to 52 weeks | Full analysis set | exacerbations per participant year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Experiencing at Least One Severe Asthma Exacerbation | Day 1 up to 52 weeks | Full analysis set | Participants | NUMBER |
| SECONDARY | Average Change From Baseline in Pre-bronchodilator FEV1 | Study weeks 0,17, 34, 52 | Full analysis set | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Study Specific Asthma Related Discontinuation | Day 1 up to 52 weeks | Full analysis set | Participants | NUMBER |
| SECONDARY | Average Change From Baseline in 'as Needed' Use | Week 0 up to 52 weeks | Full analysis set. | Number of inhalations per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent of 'as Needed' Free Days | Week 0 up to 52 weeks | Full analysis set | Percentage of 'as needed' free days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Controller Use Days | Week 0 up to 52 weeks | Full analysis set | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score | Study weeks 0, 17, 34, 52 | Full analysis set. | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score | Study weeks 0,17, 34, 52 | Full Analysis Set. | AQLQ(S) overall score | LEAST_SQUARES_MEAN |
| PRIMARY | Annual Severe Asthma Exacerbation Rate - Superiority Analysis | up to 52 weeks | Full analysis set | exacerbations per participant year | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis | Placebo Bid + Symbicort 'as Needed' (Experimental) | 0.11 | 95% Confidence Interval 0.10 to 0.13 | exacerbations per participant year | |
| Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 0.12 | 95% Confidence Interval 0.10 to 0.14 | exacerbations per participant year | |
| Number of Participants Experiencing at Least One Severe Asthma Exacerbation | Placebo Bid + Symbicort 'as Needed' (Experimental) | 177 | Participants | ||
| Number of Participants Experiencing at Least One Severe Asthma Exacerbation | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 184 | Participants | ||
| Average Change From Baseline in Pre-bronchodilator FEV1 | Placebo Bid + Symbicort 'as Needed' (Experimental) | 104.0 | 95% Confidence Interval 88.5 to 119.6 | mL | |
| Average Change From Baseline in Pre-bronchodilator FEV1 | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 136.6 | 95% Confidence Interval 121.1 to 152.2 | mL | |
| Number of Participants With Study Specific Asthma Related Discontinuation | Placebo Bid + Symbicort 'as Needed' (Experimental) | 0 | Participants | ||
| Number of Participants With Study Specific Asthma Related Discontinuation | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 4 | Participants | ||
| Average Change From Baseline in 'as Needed' Use | Placebo Bid + Symbicort 'as Needed' (Experimental) | -0.84 | 95% Confidence Interval -0.86 to -0.81 | Number of inhalations per day | |
| Average Change From Baseline in 'as Needed' Use | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | -0.87 | 95% Confidence Interval -0.89 to -0.84 | Number of inhalations per day |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Bid + Symbicort 'as Needed' (Experimental) | 2,095 | |
| Overall Study | STARTED | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 2,094 | |
| Overall Study | Patients Who Completed Treatment | Placebo Bid + Symbicort 'as Needed' (Experimental) | 1,924 | |
| Overall Study | Patients Who Completed Treatment | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 1,903 | |
| Overall Study | COMPLETED | Placebo Bid + Symbicort 'as Needed' (Experimental) | 1,985 | |
| Overall Study | COMPLETED | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 1,983 | |
| Overall Study | NOT COMPLETED | Placebo Bid + Symbicort 'as Needed' (Experimental) | 110 | |
| Overall Study | NOT COMPLETED | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 111 |
Source ClinicalTrials.gov
Adverse events224
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 | Viral upper respiratory tract infection | Infections and infestations | Placebo Bid + Symbicort 'as Needed' (Experimental) | 155 | 2,089 | 188 |
| other | Viral upper respiratory tract infection | Infections and infestations | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 168 | 2,087 | 206 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo Bid + Symbicort 'as Needed' (Experimental) | 81 | 2,089 | 95 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 84 | 2,087 | 96 |
| other | Headache | Nervous system disorders | Placebo Bid + Symbicort 'as Needed' (Experimental) | 51 | 2,089 | 69 |
| other | Headache | Nervous system disorders | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 50 | 2,087 | 68 |
| other | Bronchitis | Infections and infestations | Placebo Bid + Symbicort 'as Needed' (Experimental) | 64 | 2,089 | 70 |
| other | Bronchitis | Infections and infestations | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 78 | 2,087 | 83 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Bid + Symbicort 'as Needed' (Experimental) | 81 | 2,089 | 90 |
| other | Upper respiratory tract infection | Infections and infestations | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 89 | 2,087 | 112 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Bid + Symbicort 'as Needed' (Experimental) | 1 | 2,089 |
| Total, all-cause mortality | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 1 | 2,087 |
| Total, other adverse events | Placebo Bid + Symbicort 'as Needed' (Experimental) | 491 | 2,089 |
| Total, other adverse events | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 519 | 2,087 |
| Total, serious adverse events | Placebo Bid + Symbicort 'as Needed' (Experimental) | 66 | 2,089 |
| Total, serious adverse events | Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator) | 73 | 2,087 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo Bid + Symbicort 'as Needed' (Experimental) vs Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator): deaths from any cause | Trial comparisons |
| Placebo Bid + Symbicort 'as Needed' (Experimental) vs Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator): Number of Participants With Study Specific Asthma Related Discontinuation | Trial comparisons |
| Placebo Bid + Symbicort 'as Needed' (Experimental) vs Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator): Number of Participants Experiencing at Least One Severe Asthma Exacerbation | Trial comparisons |
| Placebo Bid + Symbicort 'as Needed' (Experimental) vs Pulmicort Bid + Terbutaline 'as Needed' (Active Comparator): serious adverse events | 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/NCT02224157
GET https://conductscience.org/api/trials/v1/NCT02224157/events?page=2