A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® Pressurized MDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS)

Updated on 28 June 2022


Add-on medication for patients with poorly controlled asthma requiring frequent hospitalization or steroid treatment to control asthma symptoms, despite being on regular asthma controller medications.


Condition Asthma
Clinical Study IdentifierTX302634
Last Modified on28 June 2022


Yes No Not Sure

Inclusion Criteria

Diagnosed with Asthma > 1 year
Currently taking 2 inhalers for asthma (or one inhaler containing two medications)
Asthma exacerbation within the past year requiring steroid treatment or hospitalization
Body Mass Index <40
Men and Women of childbearing potential must agree to appropriate birth control measures

Exclusion Criteria

Diagnosed with life threatening asthma condition
History of drug/alcohol abuse within the past year
Current untreated cancer
Smoking history >10 pack years (Packs per day x # years smoked)
Diagnosed with other pulmonary conditions
Clear my responses

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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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