Severe Eosinophilic AsthmaRANSNCT05180357
RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
An observational study of Severe Eosinophilic Asthma and Nasal Polyps, run by AstraZeneca at 45 sites in 6 countries.
Trial summary
The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Severe Eosinophilic Asthma, Nasal Polyps
- What is being tested?
- FASENRA(benralizumab)
- How many people
- 273 participants
- Where
- 45 sitesin 6 countries
- Study dates
- 23 Nov 2021to 28 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is SEA + NP patients on benralizumab.
Who may be able to join
- Current or previous treatment with benralizumab for SEA
- Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
- Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
- Able to provide signed informed consent (if required based on local guidelines)
Who cannot join
- Patient on any other biologic during the 12 months prior to treatment with benralizumab
- Previously or currently receiving any biologics for the treatment of asthma or NP in a clinical trial. This exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).
Trial locations and contacts
45 sites in 6 countries.
45 sites in 6 countries
Italy13 sites
Research Site
Catania, 95123
Research Site
Catanzaro, 88100
Research Site
Florence, 50134
Research Site
Milan, 20162
Research Site
Modena, 41124
Research Site
Monserrato, 09042
Research Site
Naples, 80131
Research Site
Orbassano
Research Site
Ragusa, 97100
Research Site
Rome, 00161
Research Site
Rome
Research Site
Salerno, 84131
Research Site
Varese, 21100
Spain11 sites
Research Site
A Coruña, 15006
Research Site
Alcorcón, 28922
Research Site
Barcelona, 08003
Research Site
Barcelona
Research Site
Cadiz, 11407
Research Site
Madrid, 28041
Research Site
Madrid
Research Site
Salamanca, 37007
Research Site
Seville, 41071
Research Site
Seville, 46017
Research Site
Valencia, 46015
United States8 sites
Research Site
Centennial, Colorado, 80112
Research Site
Denver, Colorado, 80206
Research Site
Glendale, New York, 11385
Research Site
New York, New York, 10029
Research Site
Norfolk, Virginia, 23507
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Rochester, New York, 14642
Research Site
The Bronx, New York, 10461
Japan6 sites
Research Site
Chuo-ku, Niigata-Shi
Research Site
Hiroshima
Research Site
Moriguchi-Shi
Research Site
Nagaoka-Shi
Research Site
Shinagawa-ku
Research Site
Yonago-Shi
France5 sites
Research Site
Lyon, 69317
Research Site
Marseille, 13015
Research Site
Montpellier, 34090
Research Site
Nantes
Research Site
Strasbourg
About this study
Official title: Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
Read the detailed description
In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
- Conditions
- Severe Eosinophilic Asthma, Nasal Polyps
- Being tested
- FASENRA(benralizumab)
- Keywords
- Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
- Medical subject headings
- Pulmonary Eosinophilia, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASENRA(benralizumab)Other
This is a retrospective, observational study with secondary data collection utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis.
| Study group | Role | What they receive |
|---|---|---|
| SEA+NP Patients on FASENRA (benralizumab) | SEA+NP Patients on FASENRA (benralizumab) Receives: Other: FASENRA(benralizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization.
Measured: At or up to 12 months prior to first benralizumab dose.
Secondary outcomes (8)
Total NPS
To describe the distribution (mean, median, range) of NPS (nasal polyp score) before and after initiation of benralizumab among SEA (severe eosinophilic asthma) +NP (nasal polyps) patient. NPS is the sum of the left and the right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps.
Measured: Up to 12 months prior to and up to 12 months from first benralizumab dose.
SNOT-22 total score
To describe the distribution (mean, median, range) of NP patient reported HRQoL total score (SNOT-22[Sino-nasal Outcome Test-22]) before and after initiation of benralizumab among EA+NP patients. SNOT-22 measures physical problems, functional limitations, and emotional consequences of sino-nasal conditions. SNOT-22 total score is calculated as the sum of all 22 responses and range from 0 to 110 (higher scores indicate poorer HRQoL).
Measured: Up to 12 months prior to and up to 12 months from first benralizumab dose.
Overall SCS use. SCS use for asthma only. SCS use for NP only
To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients
Measured: Up to 12 months from first benralizumab dose.
Asthma Clinical outcomes.
To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.
Measured: Up to 12 months from first benralizumab dose.
NP surgery type and/or procedure
Proportion of patients with different type of surgery and/or procedure
Measured: Up to 12 months from first benralizumab dose.
Repeated or revision surgery for NP
Proportion of patients with repeated or revision surgery
Measured: Up to 12 months from first benralizumab dose.
Time to NP surgery
Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery
Measured: Up to 12 months from first benralizumab dose.
NP surgery complications
Proportion of patients with minor and major surgical complication.
Measured: Up to 12 months from first benralizumab dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start23 Nov 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180357
- Sponsor's protocol ID
- D3250R00099
- Acronym
- RANS
- Status last verified
- Apr 2023
- First submitted
- 14 Oct 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le TT, Emmanuel B, Katial R, Tran TN, Kwiatek JJ, Cohen DS, Daniel SR, Cao Y, Shih VH, Melcon MG, Devouassoux G, Pelaia G; RANS Study Investigators. Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study. J Asthma Allergy. 2024 Apr 5;17:313-324. doi: 10.2147/JAA.S437190. eCollection 2024.
PubMed 38595692
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
- ClinicalTrials.gov ID
- NCT05180357
- Acronym / sponsor ID
- RANS / D3250R00099
- Conditions
- Severe Eosinophilic Asthma, Nasal Polyps
- Keywords
- Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
Detailed description
In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEA+NP Patients on FASENRA (benralizumab) | – | Other: FASENRA(benralizumab)SEA+NP Patients on FASENRA (benralizumab) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is SEA + NP patients on benralizumab.
Key inclusion criteria (4 listed)
- Current or previous treatment with benralizumab for SEA
- Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
- Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
- Able to provide signed informed consent (if required based on local guidelines)
Key exclusion criteria (2 listed)
- Patient on any other biologic during the 12 months prior to treatment with benralizumab
- Previously or currently receiving any biologics for the treatment of asthma or NP in a clinical trial. This exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASENRA(benralizumab)This is a retrospective, observational study with secondary data collection utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis. | Other | SEA+NP Patients on FASENRA (benralizumab) |
Primary outcome
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
Time frame: At or up to 12 months prior to first benralizumab dose.
To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization.
8 secondary outcomes
Total NPS
Time frame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
SNOT-22 total score
Time frame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
Overall SCS use. SCS use for asthma only. SCS use for NP only
Time frame: Up to 12 months from first benralizumab dose.
Asthma Clinical outcomes.
Time frame: Up to 12 months from first benralizumab dose.
NP surgery type and/or procedure
Time frame: Up to 12 months from first benralizumab dose.
Repeated or revision surgery for NP
Time frame: Up to 12 months from first benralizumab dose.
Time to NP surgery
Time frame: Up to 12 months from first benralizumab dose.
NP surgery complications
Time frame: Up to 12 months from first benralizumab dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 38595692Le TT, Emmanuel B, Katial R, Tran TN, Kwiatek JJ, Cohen DS, Daniel SR, Cao Y, Shih VH, Melcon MG, Devouassoux G, Pelaia G; RANS Study Investigators. Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study. J Asthma Allergy. 2024 Apr 5;17:313-324. doi: 10.2147/JAA.S437190. eCollection 2024.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma and Nasal Polyps, run by AstraZeneca at 45 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Italy, Spain, United States, Japan, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization. (time frame: At or up to 12 months prior to first benralizumab dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.