Adult and Adolescent Participants with Inadequately Controlled Asthma

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • sponsor
    Astra Zeneca
Updated on 4 January 2022

Summary

This is a variable length study to evaluate the efficacy and safety of a new triple therapy inhaler (Budesonide/Glycopyrronium/Formoterol) in adults and adolescents with severe asthma inadequately controlled with standard of care.

Description

This is a randomized multicenter 24 to 52 week variable length study to assess the efficacy and safety of a new triple therapy metered dose inhaler (Budesonide, Glycopyrronium, Formoterol) compared to Pulmicort and Symbicort in adult and adolescent participants with inadequately controlled asthma. 

Details
Condition Asthma
Clinical Study IdentifierTX290220
SponsorAstra Zeneca
Last Modified on4 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented history of physician-diagnosed asthma greater or equal to 1 year
Documented history of at least one asthma exacerbation requiring use of corticosteroid ( oral or IV ) in the past 12 months ( not applicable to adolescents )
Ages 12 to 80 years of age
Healthy Height to Weight ratio, BMI <40 kg/m2
Regularly using a stable daily maintenance inhaler, medium to high doses, for at least 4 weeks prior
eDiary compliance of > and/or = 70%
No respiratory infection within 4 week

Exclusion Criteria

Contact Site for Exclusion Criteria
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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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