Trial · NCT06750289
Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
NCT06750289, Phase 3, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment. Trials, record NCT06750289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06750289
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
- NCT number
- NCT06750289
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 130 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Eosinophilic Asthma
- Interventions
- ICS-LABA, benralizumab, Placebo for Benralizumab
- First posted
- 2024-12-27
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized asthma exacerbation rate | Baseline through Week 48 | To assess asthma exacerbation rate. |
| Secondary | Change in Saint George's Respiratory Questionnaire (SGRQ) total score | Baseline through Week 48 | The SGRQ is a 50-item ePRO instrument developed to measure the health status of participants with airway obstruction disease. The questionnaire is divided into 2 parts: Part 1 consists of 8 items that pertain to the severity of respiratory symptoms in the preceding 4 weeks, and Part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 component scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score ranges from 0 to 100 with 0 indicating the best possible health status and 100 representing the worst possible health status |
| Secondary | Change in pre-bronchodilator FEV1 | Baseline through Week 48 | Lung function is assessed by FEV1 which was measured by spirometry. Spirometry will be performed by the Investigator or authorized delegate according to American Thoracic Society /European Respiratory Society guidelines. |
| Secondary | Change in Asthma control questionnaire (ACQ) scale score. | Baseline through Week 48. | The ACQ-6 is a shortened version of the full 7-item ACQ questionnaire, which assesses asthma symptoms (nighttime awakening, symptoms on awakening, activity limitation, shortness of breath, wheezing, SABA use) but omits the FEV1 measurement from the original ACQ-7 assessment. Participants are asked to recall how their asthma has been during the previous week by responding to 6 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The total ACQ-6 score is the mean of the responses. The effect of benralizumab will be evaluated with the change from baseline in ACQ-6 to End of treatment (week 48) and over the treatment period. |
| Secondary | Time to first asthma exacerbation | Baseline through Week 48. | Time to the first occurrence of asthma exacerbation post randomisation. |
| Secondary | Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization | Baseline through Week 48. | The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room/urgent care visit or a hospitalization adjusted by the time of follow-up. |
| Secondary | Number and proportion of participants that meet each component of a 4-component clinical remission composite | Week 24 and Week 48. | * Number and proportion of participants that meet each component of a 4-component clinical remission composite (no exacerbations; no mOCS use; ACQ-6 \< 1.5); and stable FEV1 (defined as change from baseline in FEV1 \> -100 mL) at Week 24 and EOT. * Number and proportion of participants that meet 0, 1, 2, 3 and all 4 components of the composite remission endpoint at Week 24 and EOT. |
| Secondary | Safety Adverse Event (AEs), Serious Adverse Event (SAEs), Adverse event leading to treatment discontinuation (DAEs.) | Baseline through Week 48. |
Source ClinicalTrials.gov
Outcomes0
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.
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 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/NCT06750289
GET https://conductscience.org/api/trials/v1/NCT06750289/registered