A research study for people with severe asthma

  • STATUS
    Recruiting
  • sponsor
    GlaxoSmithKline
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Updated on 29 July 2021
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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.

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

Details
Condition Allergies & Asthma, severe asthma, Asthma (Pediatric), Asthma
Clinical Study IdentifierTX278354
SponsorGlaxoSmithKline
Last Modified on29 July 2021

Eligibility

 Yes No Not Sure

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 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)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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