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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2026-04-29

Brief Summary

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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

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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

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Asthma

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Albuterol and budesonide inhalation aerosol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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PT027

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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United States

Other Identifiers

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D6930L00001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Albuterol and budesonide inhalation aerosol

Albuterol and budesonide inhalation aerosol

Interventions

Albuterol and budesonide inhalation aerosol

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Premier HealthCare Solutions Inc.

AstraZeneca

Responsible Party

Locations

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Countries

Other Identifiers

D6930L00001