Trial · NCT06372496
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
NCT06372496, Phase 4, Active not recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma. Trials, record NCT06372496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06372496
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
- NCT number
- NCT06372496
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 1,358 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate, Inhaled corticosteroids/long-acting beta-2 agonists
- First posted
- 2024-04-18
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (CFB) in Trough 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. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value |
| Secondary | Percentage of Participants Achieving Greater Than Equal to (>=) 0.5 Point Improvement (Decrease) From Baseline for the Asthma Control Questionnaire-7 (ACQ-7) at Week 24 | Baseline (Day 1) and at Week 24 | The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, and wheeze) with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation).ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to (\<=)0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score \>=1.5 indicates poorly controlled asthma. Greater than or equal to 0.5 point decrease from baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Percentage values are rounded off. |
| Secondary | Percentage of Participants Achieving the Composite Endpoint (Optimized) at Week 52 | Baseline (Day 1) and at Week 52 | The 4-point composite endpoint is defined as meeting the following criteria: Change from baseline in trough FEV1 \>= 100 milliliter (mL) at Week 52, Controlled asthma based on ACQ-5 total score \<= 1.5 at Week 52, No severe asthma exacerbations over 52 weeks and oral corticosteroids (OCS)-free over 52 weeks |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | Baseline (Day 1) and at Week 52 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). |
| Secondary | Percentage of Participants With Change From Baseline in Trough FEV1 >= 100 mL 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. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value. Percentage values are rounded-off. |
| Secondary | Percentage of Participants With Change From Baseline in Trough FEV1 >= 100 mL at Week 52 | Baseline (Day 1) and at Week 52 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). |
| Secondary | Percentage of Participants With Change From Baseline in Trough FEV1 >= 0 mL 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. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value. Percentage values are rounded-off. |
| Secondary | Percentage of Participants With Change From Baseline in Trough FEV1 >= 0 mL at Week 52 | Baseline (Day 1) and at Week 52 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). |
| Secondary | Percentage of Participants Achieving >= 0.5 Point Improvement (Decrease) From Baseline for the ACQ-7 Score at Week 52 | Baseline (Day 1) and at Week 52 | The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze) with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to (\<=) 0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score \>= 1.5 indicates poorly controlled asthma. Greater than or equal to 0.5 point decrease from baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. |
| Secondary | Percentage of Participants Achieving >=0.5 Point Improvement (Decrease) From Baseline for the ACQ-6 Score at Week 24 | Baseline (Day 1) and at Week 24 | The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. ACQ-6 consists of 6 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. Mean scores of \<=0.75 indicate well-controlled asthma, scores between 0.75 and 1.5 indicate partially controlled asthma, and scores \>=1.5 indicate poorly controlled asthma. A decrease in ACQ-6 score from Baseline indicates an improvement in asthma control, and individual changes of at least 0.5 are considered clinically meaningful. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Percentage values are rounded off. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42474701 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT06372496
GET https://conductscience.org/api/trials/v1/NCT06372496/registered?page=2