Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI)
NCT07933510, Not yet recruiting, AstraZeneca
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Changes in Symptom and Quality of Life in Patients With Uncontrolled Asthma Treated With Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) | ClinicalTrials.gov |
| NCT number | NCT07933510 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | AstraZeneca | ClinicalTrials.gov |
| Conditions | Asthma, Uncontrolled Asthma, Asthma-COPD Overlap | ClinicalTrials.gov |
| Interventions | Budesonide/Glycopyrronium/Formoterol fumarate metered dose inhaler | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score | at Week 8 | To evaluate the change in asthma control at 8 weeks from baseline in patients with asthma initiated on BGF MDI, as measured by ACQ-5. | ClinicalTrials.gov |
| Secondary | Change in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment | at week 8 from baseline | To evaluate changes in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment (defined in 3.5) | ClinicalTrials.gov |
| Secondary | Changes in asthma control measured by ACQ-5 | at week 2 and 4 from baseline | To evaluate changes in asthma control measured by ACQ-5 at 2 and 4 weeks from baseline in the asthma patients initiated with BGF MDI | ClinicalTrials.gov |
| Secondary | Changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) | at weeks 2, 4 and 8 from baseline | To evaluate changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI | ClinicalTrials.gov |
| Secondary | Proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5 | at weeks 2, 4 and 8 from baseline | To evaluate proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5 at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI | ClinicalTrials.gov |
| Secondary | Proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score | at weeks 2, 4, 8 from baseline | To evaluate proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI | ClinicalTrials.gov |
| Secondary | Onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ) | 5 and 30 minutes after the first administration | To evaluate the onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ) at 5 and 30 minutes after the first administration | ClinicalTrials.gov |
| Secondary | Changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q) | 2, 4 and 8 weeks from baseline | To evaluate changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)