A research study for people with severe asthma

Last updated: July 26, 2021
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Allergies & Asthma

Treatment

N/A

Clinical Study ID

TX278354
206785
  • Ages 12-90
  • All Genders

Study Summary

Evaluate exacerbation rate, additional measures of asthma control and safety in adult and adolescent asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have you had asthma for at least two years, with a documented diagnosis of severe asthma?
  • Have you been taking either mepolizumab/benralizumab and a inhaled corticosteriod for at least 12 months?
  • If you are a woman cof child bearing potential are you willing to take, for the duration of the study and 4 weeks post treatment, a highly effective contraceptive?

Exclusion

Exclusion Criteria:

  • Do you currently have any other clinically significant lung condition other than asthma? Such as current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  • Do you currently have Eosinophilic Diseases, that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
  • Have you taken within the last 130 days other mAbs used in the treatment of asthma? Such as omalizumab (Xolair), dupilumab (Dupixent) or reslizumab (Cinqair/Cinqaero).

Study Design

Study Start date:
July 02, 2021
Estimated Completion Date:

Study Description

Study Procedures: Physical Exams, Pulmonary function testing, electrocardiograms, clinical safety laboratory assessments, safety assessments

Study Duration: Up to 66 weeks inclusive of prescreen and follow-up

Connect with a study center

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado 80033
    United States

    Active - Recruiting

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