ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

ANCHOR is a prospective, multi-center, phase IV, interventional, single-arm, open-label study of 2,000 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• Adults aged 18 years and above as of enrollment date.

• At least 1 visit with primary or secondary diagnosis of asthma on or within 12 months prior to the enrollment date.

• At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date.

• At least 1 asthma exacerbation within 12 months before enrollment date.

• Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date.

• Participants also need to meet each of the following inclusion criteria:

‣ Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU).

⁃ Willingness to respond to quarterly safety inquiries.

⁃ Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text.

⁃ Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI).

Locations
United States
Massachusetts
Research Site
RECRUITING
Boston
Research Site
WITHDRAWN
Springfield
Michigan
Research Site
NOT_YET_RECRUITING
Ann Arbor
Research Site
RECRUITING
Flint
Minnesota
Research Site
RECRUITING
Minneapolis
North Carolina
Research Site
NOT_YET_RECRUITING
Greenville
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2026-04-29
Participants
Target number of participants: 2000
Treatments
Experimental: Albuterol and budesonide inhalation aerosol
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Premier HealthCare Solutions Inc.

This content was sourced from clinicaltrials.gov

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