ANCHOR is a prospective, phase IV, interventional, single-arm, open-label study of 1,500 adult participants with symptomatic asthma requiring the use of rescue therapy aimed to compare the asthma exacerbation rates before and after switching from albuterol or levalbuterol to albuterol plus budesonide inhalation aerosol as rescue therapy.
This study will primarily compare rates of asthma exacerbation during 12-month pre-switch period and 12-month post switch period among participants with asthma needing a rescue therapy. Other outcomes of interest for comparison between the pre- and post-switch periods include asthma-related oral corticosteroids (OCS) use, asthma exacerbation-related hospitalizations, emergency department (ED) visits, urgent care visits, outpatient visits, telehealth visits, and asthma-related and asthma exacerbation-related healthcare costs. The use of asthma control and rescue medications will be collected to understand treatment patterns in the real-world US context.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,507
Participants will receive a fixed-dose combination of albuterol (90mcg) and budesonide (80mcg) administered as 2 inhalations (180mcg/160mcg) via pressurized metered dose inhaler (pMDI) as needed for asthma symptoms, for up to 12 inhalations (6 doses) in a 24-hour period.
Research Site
North Hollywood, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Louisville, Kentucky, United States
Asthma exacerbation
Annualized Severe Asthma exacerbation rate
Time frame: During 12-month pre-switch and 12-month post-switch periods
Asthma exacerbation-related HCRU
Percentage of patients with Asthma exacerbation-related HCRU
Time frame: During 12-month pre-switch and 12-mont post switch periods
Asthma exacerbation-related cost
Asthma exacerbation-related cost in US Dollars
Time frame: During 12-month pre-switch and 12-month post-switch periods
Asthma-related cost
Asthma-related cost in US Dollars
Time frame: During 12-month pre-switch and 12-month post-switch periods
Asthma- related Oral Corticosteroid (OCS) use
Mean number of Asthma- related Oral Corticosteroid (OCS) prescriptions
Time frame: During 12-month pre-switch and 12-month post-switch periods
Change in asthma exacerbation-related HCRU at health system level
Percentage of patients with Asthma exacerbation-related HCRU at the health system level
Time frame: During 12-month pre-switch and 12-month post-switch periods
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Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Flint, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Asheville, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Site
DuBois, Pennsylvania, United States
...and 1 more locations