## Protocol Section
### Identification Module
**NCT ID:** NCT06422689

**Acronym:** ANCHOR

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

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

#### Organization Study ID Info
**ID:** D6930L00001
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2026-04-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Premier HealthCare Solutions Inc.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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 Module

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Drug: Albuterol and budesonide inhalation aerosol

**Label:** Albuterol and budesonide inhalation aerosol

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Albuterol and budesonide inhalation aerosol

**Description:** 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.

**Name:** Albuterol and budesonide inhalation aerosol

**Other Names:**

- PT027

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Percentage of patients who reported improvement in asthma symptoms and satisfaction with albuterol and budesonide treatment as rescue therapy

**Measure:** Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire

**Time Frame:** at 3-, 6-, 9-, and 12-month post-switch

**Description:** Number of fills of asthma-related controllers and rescue medications

**Measure:** Asthma-related controller and rescue medication use

**Time Frame:** During 12-month pre-switch and 12-month post switch periods separately

#### Primary Outcomes

**Description:** Annualized Severe Asthma exacerbation rate

**Measure:** Asthma exacerbation

**Time Frame:** During 12-month pre-switch and 12-month post-switch periods

#### Secondary Outcomes

**Description:** Percentage of patients with Asthma exacerbation-related HCRU

**Measure:** Asthma exacerbation-related HCRU

**Time Frame:** During 12-month pre-switch and 12-mont post switch periods

**Description:** Asthma exacerbation-related cost in US Dollars

**Measure:** Asthma exacerbation-related cost

**Time Frame:** During 12-month pre-switch and 12-month post-switch periods

**Description:** Asthma-related cost in US Dollars

**Measure:** Asthma-related cost

**Time Frame:** During 12-month pre-switch and 12-month post-switch periods

**Description:** Mean number of Asthma- related Oral Corticosteroid (OCS) prescriptions

**Measure:** Asthma- related Oral Corticosteroid (OCS) use

**Time Frame:** During 12-month pre-switch and 12-month post-switch periods

**Description:** Percentage of patients with Asthma exacerbation-related HCRU at the health system level

**Measure:** Change in asthma exacerbation-related HCRU at health system level

**Time Frame:** During 12-month pre-switch and 12-month post-switch periods

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Adults aged 18 years and above as of enrollment date.
2. At least 1 visit with primary or secondary diagnosis of asthma on or within 12 months prior to the enrollment date.
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 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 14 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.

**Maximum Age:** 130 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** information.center@astrazeneca.com

**Name:** AstraZeneca Clinical Study Information Center

**Phone:** 1-877-240-9479

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Flint

**Country:** United States

**Facility:** Research Site

**State:** Michigan

**Status:** RECRUITING

**Zip:** 48532

**Location 2:**

**City:** Minneapolis

**Country:** United States

**Facility:** Research Site

**State:** Minnesota

**Status:** NOT_YET_RECRUITING

**Zip:** 55425

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan, Michigan, USA

**Name:** Njira Lugogo, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Jefferson Health, Pennsylvania, USA

**Name:** Neil Skolnik, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**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.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**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.

**URL:** https://vivli.org/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000058666

- Term: Adrenergic beta-2 Receptor Agonists

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Leaves

- ID: M3767

- Name: Albuterol

- Relevance: HIGH

- As Found: Adapted

- ID: M21711

- Name: Budesonide

- Relevance: HIGH

- As Found: Metabolic

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019819

- Term: Budesonide

- ID: D000000420

- Term: Albuterol

### Misc Info Module

- Version Holder: 2024-05-31
