Trial · NCT03467425
INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
NCT03467425, Phase 4, Completed, GlaxoSmithKline; results first posted 2020-09-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design. Trials, record NCT03467425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467425
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
- NCT number
- NCT03467425
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,109 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- FF/UMEC/VI, Inhaled Corticosteroid, LAMA, LABA, COPD rescue medications
- First posted
- 2018-03-16
- Last updated
- 2020-09-07
- Other registries' IDs
- eudract:2017-004369-29
- Results first posted
- 2020-09-07
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | At Week 24 | The CAT is a 8-item questionnaire, used to measure the health status of par. with COPD. Par. rated their experience on a 6-point scale: 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40. Higher scores indicate greater disease impact. Responders were par. who had a change from Baseline score \>=2 at Week 24. Non-responders were the par. who had change from Baseline score \<2 at Week 24. Change from Baseline was calculated as Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random and are presented in a separate category. Number of responders, non-responders based on CAT and par. with imputed CAT score at Week 24 are presented. |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | Baseline (Day 1) and at Week 24 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis. |
| Secondary | Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24 | At Week 24 | Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | At Week 24 | Intent-to-Treat (ITT) Population comprised of all randomized participants (any participant who received a randomization number), excluding those who were randomized in error (a screen failure and also randomized). Only those participants with non-missing covariates were included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | Baseline (Day 1) and at Week 24 | FEV1 Population comprised of all participants of the ITT population for whom a spirometry assessment was performed at any of Visit 1 (Day 1) or Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed. | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24 | At Week 24 | Critical error Population comprised of all participants of the ITT population for whom a critical error assessment was performed at Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Responders | 731 | Participants | |
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | Non-ELLIPTA MITT | Responders | 616 | Participants | |
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-responders | 756 | Participants | |
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | Non-ELLIPTA MITT | Non-responders | 835 | Participants | |
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Participants with imputed CAT score | 52 | Participants | |
| Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24 | Non-ELLIPTA MITT | Participants with imputed CAT score | 92 | Participants | |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 1.446 | Standard Error 0.0105 | Liters | |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | Non-ELLIPTA MITT | 1.396 | Standard Error 0.0108 | Liters | |
| Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24 | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 6 | Percentage of Participants | ||
| Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24 | Non-ELLIPTA MITT | 3 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 1,545 | |
| Overall Study | STARTED | Non-ELLIPTA MITT | 1,547 | |
| Overall Study | Randomized But Did Not Start IP | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 1 | |
| Overall Study | Randomized But Did Not Start IP | Non-ELLIPTA MITT | 0 | |
| Overall Study | Completed IP | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 1,256 | |
| Overall Study | Completed IP | Non-ELLIPTA MITT | 1,359 | |
| Overall Study | Not Completed IP | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 288 | |
| Overall Study | Not Completed IP | Non-ELLIPTA MITT | 188 | |
| Overall Study | Withdrew IP (WIP): Lost to Follow-up | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 15 | |
| Overall Study | Withdrew IP (WIP): Lost to Follow-up | Non-ELLIPTA MITT | 24 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events258
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 | Dyspnoea | Respiratory, thoracic and mediastinal disorders | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 32 | 1,545 | 32 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-Ellipta MITT | 3 | 1,547 | 3 |
| serious | Pneumonia | Infections and infestations | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 26 | 1,545 | 27 |
| serious | Pneumonia | Infections and infestations | Non-Ellipta MITT | 30 | 1,547 | 30 |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 26 | 1,545 | 28 |
| serious | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-Ellipta MITT | 28 | 1,547 | 29 |
| serious | Infective exacerbation of chronic obstructive airways disease | Infections and infestations | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 6 | 1,545 | 6 |
| serious | Infective exacerbation of chronic obstructive airways disease | Infections and infestations | Non-Ellipta MITT | 9 | 1,547 | 9 |
| serious | Acute myocardial infarction | Cardiac disorders | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 5 | 1,545 | 5 |
| serious | Acute myocardial infarction | Cardiac disorders | Non-Ellipta MITT | 5 | 1,547 | 5 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 8 | 1,545 |
| Total, all-cause mortality | Non-Ellipta MITT | 8 | 1,547 |
| Total, other adverse events | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 32 | 1,545 |
| Total, other adverse events | Non-Ellipta MITT | 3 | 1,547 |
| Total, serious adverse events | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | 114 | 1,545 |
| Total, serious adverse events | Non-Ellipta MITT | 114 | 1,547 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI vs Non-Ellipta MITT: deaths from any cause | Trial comparisons |
| FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI vs Non-Ellipta MITT: 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/NCT03467425
GET https://conductscience.org/api/trials/v1/NCT03467425/flow?page=2