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Corticosteroid

Albuterol + Budesonide for Asthma (ANCHOR Trial)

Phase 4
Recruiting
Led By Njira Lugogo, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged 18 years and above as of enrollment date
At least 1 asthma exacerbation within 12 months before enrollment date
Must not have
For females only - currently pregnant or breastfeeding on enrollment date
History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3-, 6-, 9-, and 12-month post-switch
Awards & highlights

Summary

This trial will study 2,000 adults with asthma to see if switching from albuterol or levalbuterol to albuterol plus budesonide inhaler helps to

Who is the study for?
This trial is for adults with asthma who often need rescue therapy. Participants should be currently using albuterol or levalbuterol and willing to switch to a combination of albuterol and budesonide as their rescue medication.
What is being tested?
The study tests if using a combo inhaler with both albuterol (a bronchodilator) and budesonide (an anti-inflammatory steroid) can reduce the number of severe asthma attacks compared to previous treatments with just albuterol or levalbuterol.
What are the potential side effects?
Possible side effects include throat irritation, coughing, headaches, increased risk of infections, potential worsening of existing tuberculosis or herpes infection, and possible adrenal suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had at least one asthma attack in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant or breastfeeding.
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I haven't had any cancer except skin cancer in the last year.
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I haven't had major lung diseases like COPD or lung cancer in the past year.
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I have not taken oral steroids regularly in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-, 6-, 9-, and 12-month post-switch
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-, 6-, 9-, and 12-month post-switch for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma exacerbation
Secondary outcome measures
Asthma exacerbation-related HCRU
Asthma exacerbation-related cost
Asthma- related Oral Corticosteroid (OCS) use
+2 more
Other outcome measures
Asthma-related controller and rescue medication use
Improvement in patient reported asthma symptoms and treatment satisfaction using the ANCHOR PRO Questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Albuterol and budesonide inhalation aerosolExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,644,809 Total Patients Enrolled
344 Trials studying Asthma
657,966 Patients Enrolled for Asthma
Premier HealthCare Solutions Inc.UNKNOWN
Njira Lugogo, MDPrincipal InvestigatorUniversity of Michigan, Michigan, USA
3 Previous Clinical Trials
40,844 Total Patients Enrolled
3 Trials studying Asthma
40,844 Patients Enrolled for Asthma
~1333 spots leftby Apr 2026
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