Adult and Adolescent Participants with Inadequately Controlled Asthma

Last updated: January 4, 2022
Sponsor: Astra Zeneca
Overall Status: Active - Recruiting







Clinical Study ID

D5982C00007 ( KALOS )
  • Ages 12-80
  • All Genders

Study 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.

Eligibility Criteria


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

Study Design

Study Start date:
January 15, 2022
Estimated Completion Date:
December 13, 2023

Study 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.

Connect with a study center

  • North Carolina Clinical Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

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