Trial · NCT02157935
Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
NCT02157935, Phase 3, Completed, AstraZeneca; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease. Trials, record NCT02157935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02157935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
- NCT number
- NCT02157935
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,026 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COPD Patients
- Interventions
- Symbicort, Formoterol turbohaler, Placebo for Symbicort pMDI, Placebo for Formoterol Turbohaler
- First posted
- 2014-06-06
- Last updated
- 2017-11-07
- Results first posted
- 2017-06-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days | Randomization at Week 0 to End of Treatment (EoT) W 26 | The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including \>24 hours in ED/urgent care setting). |
| Secondary | Number of Patients With Moderate or Severe COPD Exacerbation. | From randomzation to EoT W 26 | The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms . The hazard ratio and 95% CI were estimated. |
| Secondary | St. George's Respiratory Questionnaire (SGRQ) | From Run-in W -4 to EoT W 26 | SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study. The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact). Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life. The total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire. Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status. The change from baseline was statistically summarized and compared between two arms in a mixed model. |
| Secondary | Pre-dose/Pre-bronchodilator FEV1 at the Study Site | From Run-in W -4 to EoT W 26 | FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model. |
| Secondary | Total Rescue Medication Use (Average Puffs/Day) | From Run-in W -4 to EoT W 26 | Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator. The average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model. |
| Secondary | Nights With Awakening Due to COPD | From Run-in W -4 to EoT W 26 | Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD. The average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days | Randomization at Week 0 to End of Treatment (EoT) W 26 | Full analysis set including all randomized subjects | COPD exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With Moderate or Severe COPD Exacerbation. | From randomzation to EoT W 26 | Participants | NUMBER | |
| SECONDARY | St. George's Respiratory Questionnaire (SGRQ) | From Run-in W -4 to EoT W 26 | The change from baseline in SGRQ were analyzed on randomized patients with a baseline SGRQ and at least one post-baseline value. Among 1219 patients who were randomized, only 589 patients in Symbicort group and 593 patients in Formoterol group had valid data and included in analysis. | scores on a scale | MEAN |
| SECONDARY | Pre-dose/Pre-bronchodilator FEV1 at the Study Site | From Run-in W -4 to EoT W 26 | The change from baseline in pre-dose FEV1 were analyzed on randomized patients with a baseline pre-dose FEV1 and at least one post-baseline value. Among 1219 patients who were randomized, only 588 patients in Symbicort group and 589 patients in Formoterol group had valid data and included in analysis. | L | MEAN |
| SECONDARY | Total Rescue Medication Use (Average Puffs/Day) | From Run-in W -4 to EoT W 26 | The change from baseline on rescue medication use were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 602 patients in Symbicort group and 607 patients in Formoterol group had valid data and included in analysis. | puffs/day | MEAN |
| SECONDARY | Nights With Awakening Due to COPD | From Run-in W -4 to EoT W 26 | The change from baseline on awakening were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 603 patients in Symbicort group and 610 patients in Formoterol group had valid data and included in analysis. | awakening/night | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days | Symbicort pMDI | 0.85 | 95% Confidence Interval 0.70 to 1.03 | COPD exacerbations per year | |
| The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days | Formoterol Turbuhaler | 1.12 | 95% Confidence Interval 0.93 to 1.35 | COPD exacerbations per year | |
| Number of Patients With Moderate or Severe COPD Exacerbation. | Symbicort pMDI | 171 | Participants | ||
| Number of Patients With Moderate or Severe COPD Exacerbation. | Formoterol Turbuhaler | 204 | Participants | ||
| St. George's Respiratory Questionnaire (SGRQ) | Symbicort pMDI | -0.855 | Standard Deviation 8.941 | scores on a scale | |
| St. George's Respiratory Questionnaire (SGRQ) | Formoterol Turbuhaler | 0.442 | Standard Deviation 9.457 | scores on a scale | |
| Pre-dose/Pre-bronchodilator FEV1 at the Study Site | Symbicort pMDI | 0.008 | Standard Deviation 0.210 | L | |
| Pre-dose/Pre-bronchodilator FEV1 at the Study Site | Formoterol Turbuhaler | -0.025 | Standard Deviation 0.198 | L | |
| Total Rescue Medication Use (Average Puffs/Day) | Symbicort pMDI | 0.135 | Standard Deviation 1.248 | puffs/day | |
| Total Rescue Medication Use (Average Puffs/Day) | Formoterol Turbuhaler | 0.343 | Standard Deviation 1.456 | puffs/day |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 pMDI | 606 | |
| Overall Study | STARTED | Formoterol Turbuhaler | 613 | |
| Overall Study | COMPLETED | Symbicort pMDI | 567 | |
| Overall Study | COMPLETED | Formoterol Turbuhaler | 548 | |
| Overall Study | NOT COMPLETED | Symbicort pMDI | 39 | |
| Overall Study | NOT COMPLETED | Formoterol Turbuhaler | 65 |
Source ClinicalTrials.gov
Adverse events152
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 | Formoterol 4.5 ug x2 Bid | 32 | 613 | 35 |
| other | Nasopharyngitis | Infections and infestations | Symbicort 160/4.5 ug x2 Bid | 30 | 605 | 34 |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Formoterol 4.5 ug x2 Bid | 27 | 613 | 31 |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Symbicort 160/4.5 ug x2 Bid | 8 | 605 | 8 |
| serious | Anaemia | Blood and lymphatic system disorders | Formoterol 4.5 ug x2 Bid | 1 | 613 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Symbicort 160/4.5 ug x2 Bid | 0 | 605 | 0 |
| serious | Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | Formoterol 4.5 ug x2 Bid | 0 | 613 | 0 |
| serious | Retroperitoneal lymphadenopathy | Blood and lymphatic system disorders | Symbicort 160/4.5 ug x2 Bid | 1 | 605 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | Formoterol 4.5 ug x2 Bid | 1 | 613 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | Symbicort 160/4.5 ug x2 Bid | 0 | 605 | 0 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Formoterol 4.5 ug x2 Bid | ||
| Total, all-cause mortality | Symbicort 160/4.5 ug x2 Bid | ||
| Total, other adverse events | Formoterol 4.5 ug x2 Bid | 56 | 613 |
| Total, other adverse events | Symbicort 160/4.5 ug x2 Bid | 38 | 605 |
| Total, serious adverse events | Formoterol 4.5 ug x2 Bid | 63 | 613 |
| Total, serious adverse events | Symbicort 160/4.5 ug x2 Bid | 49 | 605 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Symbicort pMDI vs Formoterol Turbuhaler: Number of Patients With Moderate or Severe COPD Exacerbation. | Trial comparisons |
| Formoterol 4.5 ug x2 Bid vs Symbicort 160/4.5 ug x2 Bid: 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/NCT02157935
GET https://conductscience.org/api/trials/v1/NCT02157935/events?page=2