NCT06422689

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,511 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-05-10
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-05-21
• Last updated: 2026-04-06

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study