Trial · NCT05384938
FAsenra Safety Trial in India
NCT05384938, Phase 4, Completed, AstraZeneca; results first posted 2024-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FAsenra Safety Trial in India. Trials, record NCT05384938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05384938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FAsenra Safety Trial in India
- NCT number
- NCT05384938
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 139 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India
- Interventions
- Benralizumab
- First posted
- 2022-05-20
- Last updated
- 2024-12-11
- Results first posted
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | From study treatment to follow-up (up to 24 weeks) | The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented |
| Primary | Severity of AEs | From study treatment to follow-up (up to 24 weeks) | Severity of adverse events (AEs) by intensity grade |
| Primary | Participants With AEs That Led to Study Treatment Discontinuations or Modifications | From study treatment to follow-up (up to 24 weeks) | Participants with adverse events (AEs) that led to study treatment discontinuations or modifications |
| Secondary | Time to First Asthma Exacerbation | From study treatment to follow-up (up to 24 weeks) | Time to first asthma exacerbation in days in participants with asthma exacerbation |
| Secondary | Exacerbation Rate: Before and After Treatment | From study treatment to follow-up (up to 24 weeks) | The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365. |
| Secondary | Annualized Exacerbation Rate: Overall | From study treatment to follow-up (up to 24 weeks) | Overall annualized exacerbation rate. The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365. |
| Secondary | Overall Investigators Assessment | From study treatment to follow-up (up to 24 weeks) | Overall investigator's assessment on the outcome of the treatment: "well controlled", "partly controlled", and "uncontrolled." |
| Secondary | Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24 | Baseline and Weeks 4, 16, and 24 | Mean change in blood eosinophil levels from baseline at Weeks 4, 16, and 24 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | From study treatment to follow-up (up to 24 weeks) | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Severity of AEs | From study treatment to follow-up (up to 24 weeks) | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With AEs That Led to Study Treatment Discontinuations or Modifications | From study treatment to follow-up (up to 24 weeks) | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Asthma Exacerbation | From study treatment to follow-up (up to 24 weeks) | Evaluable Analysis Set | days | MEAN |
| SECONDARY | Exacerbation Rate: Before and After Treatment | From study treatment to follow-up (up to 24 weeks) | Evaluable Analysis Set | exacerbations events/year | MEAN |
| SECONDARY | Annualized Exacerbation Rate: Overall | From study treatment to follow-up (up to 24 weeks) | Evaluable Analysis Set | exacerbation events/year | NUMBER |
| SECONDARY | Overall Investigators Assessment | From study treatment to follow-up (up to 24 weeks) | Evaluable Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24 | Baseline and Weeks 4, 16, and 24 | Evaluable Analysis Set | cells/mm^3 | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | Benralizumab | Participants with at least one AE (including SAEs) | 44 | Participants | |
| Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | Benralizumab | Participants with at least one serious AE | 5 | Participants | |
| Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | Benralizumab | Participants with at least one treatment-emergent AE (including SAEs) | 43 | Participants | |
| Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs | Benralizumab | Participants with at least one non-treatment-emergent and non-serious AE | 1 | Participants | |
| Severity of AEs | Benralizumab | Participants with at least one mild AE | 33 | Participants | |
| Severity of AEs | Benralizumab | Participants with at least one moderate AE | 16 | Participants | |
| Severity of AEs | Benralizumab | Participants with at least one severe AE | 1 | Participants | |
| Participants With AEs That Led to Study Treatment Discontinuations or Modifications | Benralizumab | 0 | Participants | ||
| Time to First Asthma Exacerbation | Benralizumab | 112.6 | Standard Deviation 50.45 | days | |
| Exacerbation Rate: Before and After Treatment | Benralizumab | Exacerbation before study | 2.0 | Standard Deviation 0.00 | exacerbations events/year |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab | 139 | |
| Overall Study | COMPLETED | Benralizumab | 124 | |
| Overall Study | NOT COMPLETED | Benralizumab | 15 |
Source ClinicalTrials.gov
Adverse events32
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 | Ulcer | General disorders | Benralizumab | 1 | 138 | 1 |
| other | Covid-19 | Infections and infestations | Benralizumab | 1 | 138 | 1 |
| other | Nasopharyngitis | Infections and infestations | Benralizumab | 3 | 138 | 3 |
| other | Urinary tract infection | Infections and infestations | Benralizumab | 1 | 138 | 1 |
| other | Sars-cov-2 test positive | Investigations | Benralizumab | 1 | 138 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Benralizumab | 1 | 138 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Benralizumab | 1 | 138 | 1 |
| other | Burning sensation | Nervous system disorders | Benralizumab | 1 | 138 | 1 |
| other | Constipation | Gastrointestinal disorders | Benralizumab | 1 | 138 | 1 |
| other | Headache | Nervous system disorders | Benralizumab | 2 | 138 | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab | 0 | 138 |
| Total, other adverse events | Benralizumab | 39 | 138 |
| Total, serious adverse events | Benralizumab | 5 | 138 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42089065 | 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/NCT05384938
GET https://conductscience.org/api/trials/v1/NCT05384938/events?page=2