AsthmaPhase 4ANCHORNCT06422689
Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
A Phase 4 study testing Albuterol and budesonide inhalation aerosol in people with Asthma, run by AstraZeneca at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol and budesonide inhalation aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,511 participants
- Where
- 11 sitesUnited States
- Study dates
- 10 May 2024to 3 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants also need to meet each of the following inclusion criteria:
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Asheville, North Carolina, 28803
Research Site
Austin, Texas, 78738
Research Site
Boston, Massachusetts, 02111
Research Site
DuBois, Pennsylvania, 15801
Research Site
Flint, Michigan, 48532
Research Site
Greenville, North Carolina, 27834
Research Site
Louisville, Kentucky, 40217
Research Site
Minneapolis, Minnesota, 55425
Research Site
North Hollywood, California, 91602
Research Site
Walnut Creek, California, 94598
About this study
Official title: 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.
Read the 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
- Being tested
- Albuterol and budesonide inhalation aerosol
- 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
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol and budesonide inhalation aerosolDrug
Also called PT027
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albuterol and budesonide inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbation
Annualized Severe Asthma exacerbation rate
Measured: During 12-month pre-switch and 12-month post-switch periods
Secondary outcomes (5)
Asthma exacerbation-related HCRU
Percentage of patients with Asthma exacerbation-related HCRU
Measured: During 12-month pre-switch and 12-mont post switch periods
Asthma exacerbation-related cost
Asthma exacerbation-related cost in US Dollars
Measured: During 12-month pre-switch and 12-month post-switch periods
Asthma-related cost
Asthma-related cost in US Dollars
Measured: 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
Measured: 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
Measured: During 12-month pre-switch and 12-month post-switch periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start10 May 2024
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier HealthCare Solutions Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422689
- Sponsor's protocol ID
- D6930L00001
- Acronym
- ANCHOR
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
- ClinicalTrials.gov ID
- NCT06422689
- Acronym / sponsor ID
- ANCHOR / D6930L00001
- Conditions
- Asthma
- Keywords
- Effectiveness, Asthma, Exacerbation, Healthcare resource utilization, Cost, Albuterol/budesonide, Short-acting beta-agonist (SABA), Inhaled corticosteroids (ICS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,511 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Premier HealthCare Solutions Inc.
- Study start
- 10 May 2024 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albuterol and budesonide inhalation aerosol | Experimental | Drug: Albuterol and budesonide inhalation aerosolParticipants 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol and budesonide inhalation aerosolAlso: PT027Participants 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 |
Primary outcome
Asthma exacerbation
Time frame: During 12-month pre-switch and 12-month post-switch periods
Annualized Severe Asthma exacerbation rate
5 secondary outcomes
Asthma exacerbation-related HCRU
Time frame: During 12-month pre-switch and 12-mont post switch periods
Asthma exacerbation-related cost
Time frame: During 12-month pre-switch and 12-month post-switch periods
Asthma-related cost
Time frame: During 12-month pre-switch and 12-month post-switch periods
Asthma- related Oral Corticosteroid (OCS) use
Time frame: During 12-month pre-switch and 12-month post-switch periods
Change in asthma exacerbation-related HCRU at health system level
Time frame: During 12-month pre-switch and 12-month post-switch periods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albuterol and budesonide inhalation aerosol in people with Asthma, run by AstraZeneca at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbation (time frame: During 12-month pre-switch and 12-month post-switch periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.