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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Albuterol and budesonide inhalation aerosol

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.

• Study Type: Interventional
• Enrollment (Actual): 1511
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • North Hollywood, California, United States, 91602
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
    • Flint, Michigan, United States, 48532
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55425
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Research Site
    • Greenville, North Carolina, United States, 27834
      • Research Site
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Research Site
  • Texas
    • Austin, Texas, United States, 78738
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 18 years and above as of enrollment date.
2. At least 1 diagnosis of asthma prior to the enrollment date documented in patient record.
3. 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.
4. At least 1 severe asthma exacerbation within 12 months before enrollment date.
5. 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.

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

   1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU).
   2. Willingness to respond to quarterly safety inquiries.
   3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text.
   4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI).

Exclusion Criteria:

1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date.
2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use.
3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 21 days or longer.
4. History of albuterol and budesonide as rescue use within 12 months before enrollment date.
5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date.
6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: PT027

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma exacerbation	Annualized Severe Asthma exacerbation rate	During 12-month pre-switch and 12-month post-switch periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma exacerbation-related HCRU	Percentage of patients with Asthma exacerbation-related HCRU	During 12-month pre-switch and 12-mont post switch periods
Asthma exacerbation-related cost	Asthma exacerbation-related cost in US Dollars	During 12-month pre-switch and 12-month post-switch periods
Asthma-related cost	Asthma-related cost in US Dollars	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	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	During 12-month pre-switch and 12-month post-switch periods

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire	Percentage of patients who reported improvement in asthma symptoms and satisfaction with albuterol and budesonide treatment as rescue therapy	at 3-, 6-, 9-, and 12-month post-switch
Asthma-related controller and rescue medication use	Number of fills of asthma-related controllers and rescue medications	During 12-month pre-switch and 12-month post switch periods separately
Experience of (yes/no) and number of safety events	Number of adverse events (AE) and serious adverse events (SAE)	During 12-month post-switch period

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Premier HealthCare Solutions Inc.
• Investigators: Principal Investigator: Njira Lugogo, MD, University of Michigan, Michigan, USA; Principal Investigator: Neil Skolnik, MD, Jefferson Health, Pennsylvania, USA

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Exacerbation; Effectiveness; Cost; Healthcare resource utilization; Switch; Rescue; Inhaled corticosteroids (ICS); Albuterol/budesonide; Short-acting beta-agonist (SABA); Oral corticosteroid; Patients reported asthma symptoms; PT027
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Amines; Alcohols; Amino Alcohols; Ethanolamines; Phenethylamines; Ethylamines; Albuterol
• Other Study ID Numbers: D6930L00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No