RECRUITING

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period.

Official Title

A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics

Quick Facts

Study Start:2019-10-17
Study Completion:2026-09-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03953300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female aged 18 through 70 years.
  2. 2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
  3. 3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
  4. 4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
  5. 5. Negative pregnancy test.
  6. 6. Asthma control questionnaire (ACQ-6) \>1.5.
  7. 7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.
  1. 1. Any disease or concomitant medication which could affect study results or safety of study participants, including:
  2. * current smokers
  3. * history of cancer
  4. * life-threatening asthma
  5. * clinically important pulmonary disease other than asthma
  6. 2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
  7. 3. Previously received:
  8. * benralizumab
  9. * live attenuated vaccines 30 days prior to the date of randomization.
  10. * bronchial thermoplasty in the last 24 months prior to Visit 1
  11. * any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
  12. * any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
  13. 4. Currently pregnant, breastfeeding or lactating women.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Mario Castro, MD
PRINCIPAL_INVESTIGATOR
University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35209
United States
Research Site
Los Angeles, California, 90033
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Jacksonville, Florida, 32204
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Miami, Florida, 33166
United States
Research Site
Decatur, Georgia, 30033
United States
Research Site
Snellville, Georgia, 30078
United States
Research Site
Indianapolis, Indiana, 46268
United States
Research Site
Iowa City, Iowa, 52242
United States
Research Site
Hutchinson, Kansas, 67502
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
Boston, Massachusetts, 02115
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Bloomfield Hills, Michigan, 48301
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Saint Louis, Missouri, 63156
United States
Research Site
Maspeth, New York, 11378
United States
Research Site
Port Jefferson Station, New York, 11776
United States
Research Site
Durham, North Carolina, 27705
United States
Research Site
New Bern, North Carolina, 28562
United States
Research Site
Winston-Salem, North Carolina, 27104
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Pittsburgh, Pennsylvania, 15213
United States
Research Site
Sayre, Pennsylvania, 18840
United States
Research Site
Charleston, South Carolina, 29414
United States
Research Site
Galveston, Texas, 77555
United States
Research Site
Lewisville, Texas, 75067
United States
Research Site
Mansfield, Texas, 76063
United States
Research Site
McAllen, Texas, 78503
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Williamsburg, Virginia, 23188
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Mario Castro, MD, PRINCIPAL_INVESTIGATOR, University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-17
Study Completion Date2026-09-09

Study Record Updates

Study Start Date2019-10-17
Study Completion Date2026-09-09

Terms related to this study

Keywords Provided by Researchers

  • Asthma
  • Eosinophilic Asthma
  • Lung Diseases
  • Inhaled Corticosteroids
  • ICS
  • LABA
  • benralizumab
  • Fasenra
  • mechanism of action
  • remodeling

Additional Relevant MeSH Terms

  • Asthma