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

NCT06422689 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: D6930L00001
• Study Type: interventional
• Target: 1,507
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Asthma

Keywords

Effectiveness; Asthma; Exacerbation; Healthcare resource utilization; Cost; Albuterol/budesonide; Short-acting beta-agonist (SABA); Inhaled corticosteroids (ICS); Rescue; Switch; Oral corticosteroid; Patients reported asthma symptoms; PT027

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbation

  Annualized Severe Asthma exacerbation rate

  During 12-month pre-switch and 12-month post-switch periods

Secondary Outcomes (5)

• Asthma exacerbation-related HCRU

  During 12-month pre-switch and 12-mont post switch periods

• Asthma exacerbation-related cost

  During 12-month pre-switch and 12-month post-switch periods

• Asthma-related cost

  During 12-month pre-switch and 12-month post-switch periods

• Asthma- related Oral Corticosteroid (OCS) use

  During 12-month pre-switch and 12-month post-switch periods

• Change in asthma exacerbation-related HCRU at health system level

  During 12-month pre-switch and 12-month post-switch periods

Other Outcomes (3)

• Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire

  at 3-, 6-, 9-, and 12-month post-switch

• Asthma-related controller and rescue medication use

  During 12-month pre-switch and 12-month post switch periods separately

• Experience of (yes/no) and number of safety events

  During 12-month post-switch period

Study Arms (1)

Albuterol and budesonide inhalation aerosol

EXPERIMENTAL

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

Interventions

Albuterol and budesonide inhalation aerosol DRUG

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.

Also known as: PT027

Albuterol and budesonide inhalation aerosol

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and above as of enrollment date.
• At least 1 diagnosis of asthma prior to the enrollment date documented in patient record.
• 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 severe 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.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.
• History of albuterol and budesonide as rescue use within 12 months before enrollment date.
• History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date.
• For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.

Sponsors & Collaborators

• AstraZeneca: lead
• Premier HealthCare Solutions Inc.: collaborator

Study Sites (11)

Research Site

North Hollywood, California, 91602, United States

Location

Research Site

Walnut Creek, California, 94598, United States

Location

Research Site

Louisville, Kentucky, 40217, United States

Location

Research Site

Boston, Massachusetts, 02111, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Flint, Michigan, 48532, United States

Location

Research Site

Minneapolis, Minnesota, 55425, United States

Location

Research Site

Asheville, North Carolina, 28803, United States

Location

Research Site

Greenville, North Carolina, 27834, United States

Location

Research Site

DuBois, Pennsylvania, 15801, United States

Location

Research Site

Austin, Texas, 78738, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 21, 2024
• Study Start: May 10, 2024
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (11)