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NCT05180357 | COMPLETED | Severe Eosinophilic Asthma

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

AstraZeneca

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.

Condition or disease

Severe Eosinophilic Asthma

Nasal Polyps

Intervention/treatment

FASENRA(benralizumab)

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 Type : OBSERVATIONAL
Estimated Enrollment : 273 participants
Official Title : Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
Actual Study Start Date : 2021-11-23
Estimated Primary Completion Date : 2022-10-28
Estimated Study Completion Date : 2022-10-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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).
RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

Location Details

NCT05180357

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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United States, Colorado

Research Site

Centennial, Colorado, United States, 80112

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United States, Colorado

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Denver, Colorado, United States, 80206

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United States, New York

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Bronx, New York, United States, 10461

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United States, New York

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Glendale, New York, United States, 11385

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United States, New York

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New York, New York, United States, 10029

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United States, New York

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Rochester, New York, United States, 14642

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United States, Pennsylvania

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Philadelphia, Pennsylvania, United States, 19107

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United States, Virginia

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Norfolk, Virginia, United States, 23507

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France,

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Lyon, France, 69317

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France,

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Marseille, France, 13015

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France,

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Montpellier, France, 34090

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France,

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Nantes, France,

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France,

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Strasbourg, France,

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Germany,

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Lubeck, Germany,

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Germany,

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Wiesbaden, Germany, 65183

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Italy,

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Catania, Italy, 95123

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Italy,

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Catanzaro, Italy, 88100

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Italy,

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Firenze, Italy, 50134

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Italy,

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Milan, Italy, 20162

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Italy,

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Modena, Italy, 41124

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Italy,

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Monserrato, Italy, 09042

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Italy,

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Napoli, Italy, 80131

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Italy,

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Orbassano, Italy,

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Italy,

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Ragusa, Italy, 97100

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Italy,

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Rome, Italy, 00161

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Italy,

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Rome, Italy,

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Italy,

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Salerno, Italy, 84131

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Italy,

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Varese, Italy, 21100

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Japan,

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C goods-cry, Niigata-shi, Japan,

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Japan,

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Hiroshima, Japan,

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Japan,

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Mr. Moriguchi, Japan,

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Japan,

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Mr. Nagaoka, Japan,

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Japan,

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The product is the work, Japan,

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Japan,

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Mr. Yonago, Japan,

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Spain,

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The Crown, Spain, 15006

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Spain,

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Alcorcon, Spain, 28922

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Spain,

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Barcelona, Spain, 08003

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Spain,

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Barcelona, Spain,

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Spain,

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Cadiz, Spain, 11407

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Spain,

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Madrid, Spain, 28041

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Spain,

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Madrid, Spain,

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Spain,

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Salamanca, Spain, 37007

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Spain,

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Sevilla, Spain, 41071

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Spain,

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Sevilla, Spain, 46017

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Spain,

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Valencia, Spain, 46015