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

NCT05180357 | Completed

• 1 other identifier: D3250R00099
• Study Type: observational
• Target: 273
• Locations: 6 countries
• Sites: 45

Brief 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.

Conditions

Severe Eosinophilic Asthma; Nasal Polyps

Keywords

Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total NPS

  Up to 12 months prior to and up to 12 months from first benralizumab dose.

• SNOT-22 total score

  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

  Up to 12 months from first benralizumab dose.

• Asthma Clinical outcomes.

  Up to 12 months from first benralizumab dose.

• NP surgery type and/or procedure

  Up to 12 months from first benralizumab dose.

Other Outcomes (6)

• Asthma medications

  Up to 12 months from first benralizumab dose.

• NP medications

  Up to 12 months from first benralizumab dose.

• All-cause healthcare resource utilization

  Up to 12 months from first benralizumab dose.

Study Arms (1)

SEA+NP Patients on FASENRA (benralizumab)

SEA+NP Patients on FASENRA (benralizumab)

Other: FASENRA(benralizumab)

Interventions

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.

SEA+NP Patients on FASENRA (benralizumab)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is SEA + NP patients on benralizumab.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (45)

Research Site

Centennial, Colorado, 80112, United States

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Denver, Colorado, 80206, United States

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Glendale, New York, 11385, United States

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New York, New York, 10029, United States

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Rochester, New York, 14642, United States

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The Bronx, New York, 10461, United States

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Philadelphia, Pennsylvania, 19107, United States

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Norfolk, Virginia, 23507, United States

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Lyon, 69317, France

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Marseille, 13015, France

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Montpellier, 34090, France

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Nantes, France

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Strasbourg, France

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Lübeck, Germany

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Wiesbaden, 65183, Germany

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Catania, 95123, Italy

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Catanzaro, 88100, Italy

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Florence, 50134, Italy

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Milan, 20162, Italy

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Modena, 41124, Italy

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Monserrato, 09042, Italy

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Napoli, 80131, Italy

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Orbassano, Italy

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Ragusa, 97100, Italy

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Rome, 00161, Italy

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Rome, Italy

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Salerno, 84131, Italy

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Varese, 21100, Italy

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Chuo-ku, Niigata-Shi, Japan

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Hiroshima, Japan

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Moriguchi-Shi, Japan

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Nagaoka-Shi, Japan

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Shinagawa-ku, Japan

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Yonago-Shi, Japan

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A Coruña, 15006, Spain

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Alcorcón, 28922, Spain

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Barcelona, 08003, Spain

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Barcelona, Spain

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Cadiz, 11407, Spain

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Madrid, 28041, Spain

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Madrid, Spain

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Salamanca, 37007, Spain

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Seville, 41071, Spain

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Seville, 46017, Spain

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Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 38595692 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Eosinophilia; Nasal Polyps

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: January 6, 2022
• Study Start: November 23, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

FR (5); DE (2); JP (6); ES (11); US (8); IT (13)