RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

Nasal Polyps Clinical Trial

— RANS  

Official title:

Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180357
• Other study ID #: D3250R00099
• Status: Completed
• Start date: November 23, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: April 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Current or previous treatment with benralizumab for SEA

2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection

3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab

4. Able to provide signed informed consent (if required based on local guidelines)

Exclusion Criteria:

1. Patient on any other biologic during the 12 months prior to treatment with benralizumab

2. 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).

Related Conditions & MeSH terms

• Asthma
• Nasal Polyps
• Polyps
• Pulmonary Eosinophilia
• Severe Eosinophilic Asthma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Nantes
France	Research Site	Strasbourg
Germany	Research Site	Lubeck
Germany	Research Site	Wiesbaden
Italy	Research Site	Catania
Italy	Research Site	Catanzaro
Italy	Research Site	Firenze
Italy	Research Site	Milan
Italy	Research Site	Modena
Italy	Research Site	Monserrato
Italy	Research Site	Napoli
Italy	Research Site	Orbassano
Italy	Research Site	Ragusa
Italy	Research Site	Rome
Italy	Research Site	Rome
Italy	Research Site	Salerno
Italy	Research Site	Varese
Japan	Research Site	Chuo-ku, Niigata-Shi
Japan	Research Site	Hiroshima-Shi
Japan	Research Site	Moriguchi-Shi
Japan	Research Site	Nagaoka-Shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Yonago-Shi
Spain	Research Site	A Coruna
Spain	Research Site	Alcorcon
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Cadiz
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Salamanca
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
United States	Research Site	Bronx	New York
United States	Research Site	Centennial	Colorado
United States	Research Site	Denver	Colorado
United States	Research Site	Glendale	New York
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Asthma medications	To describe asthma medications.	Up to 12 months from first benralizumab dose.
Other	NP medications	To describe NP medications.	Up to 12 months from first benralizumab dose.
Other	All-cause healthcare resource utilization	To describe all-cause healthcare resources utilization.	Up to 12 months from first benralizumab dose.
Other	Asthma-related healthcare resources utilization	To describe asthma-related healthcare resources utilization.	Up to 12 months from first benralizumab dose.
Other	NPS by subgroups	To describe the distribution (mean, median) of NPS among subgroups of patients with different characteristics: demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations).; NPS is the the sum of left and right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps.	Up to 12 months prior to and up to 12 months from first benzelizumab dose.
Other	SNOT-22 total score by subgroups	To describe the distribution (mean, median) of SNOT-22 total scores among subgroups of patients with different characteristics : demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations).; 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).	Up to 12 months prior to and up to 12 months from first benralizumab dose.
Primary	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.	At or up to 12 months prior to first benralizumab dose.
Secondary	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.	Up to 12 months prior to and up to 12 months from first benralizumab dose.
Secondary	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).	Up to 12 months prior to and up to 12 months from first benralizumab dose.
Secondary	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	Up to 12 months from first benralizumab dose.
Secondary	Asthma Clinical outcomes.	To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.	Up to 12 months from first benralizumab dose.
Secondary	NP surgery type and/or procedure	Proportion of patients with different type of surgery and/or procedure	Up to 12 months from first benralizumab dose.
Secondary	Repeated or revision surgery for NP	Proportion of patients with repeated or revision surgery	Up to 12 months from first benralizumab dose.
Secondary	Time to NP surgery	Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery	Up to 12 months from first benralizumab dose.
Secondary	NP surgery complications	Proportion of patients with minor and major surgical complication.	Up to 12 months from first benralizumab dose.

External Links

•   CSR Synopsis