Add on treatment for Asthma for patients who experience frequent exacerbations

  • STATUS
    Recruiting
  • sponsor
    GSK
Updated on 13 July 2022

Summary

This is a study involving an add-on injectable medication for asthmatic patients who experience frequent exacerbation of their symptoms, requiring additional medications and/or medical care to treat.

Description

Investigational Product
GSK3511294
IP Description
anti-interleukin-5 therapy subcutaneous injection 100 mg every 26 weeks
Comparator
Placebo
Ratio
2:1 Study Drug: Placebo
Length of Study
Prescreen <2 weeks; Run-in: 1-6 Weeks; Treatment: 52 Weeks
# Visits
17
Compensation
$79.00/Visit
Other:
Subjects who complete the study will be eligible for Open label Extension study
Key Procedures:
Spirometry, Physical Exam, bloodwork, Vitals, Diary, Questionnaires,

Details
Condition Asthma
Clinical Study IdentifierTX303945
SponsorGSK
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >12
Diagnosed with asthma > 2 years
≥ asthma exacerbations requiring steroid treatment or hospitalization < 12 months
Currently using Inhaled corticosteroid treatment
Must also be on another asthma medication (ie, from the classes called LABA, LAMA or LTRA)

Exclusion Criteria

Diagnosed with another chronic respiratory disease
Experienced a parasitic infection < 6 months
Diagnosed with HIV+ or other immunodeficiency diseases
Cancer < 12 mo
Liver disease or unstable hepatitis
Use of any other injectable biologic medication < 4 months
Current or former smokers who smoked an average of a pack per day for more than 10 years
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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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