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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3-, 6-, 9-, and 12-month post-switch

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma exacerbation

Secondary study objectives

Asthma exacerbation-related HCRU

Asthma exacerbation-related cost

Asthma- related Oral Corticosteroid (OCS) use

+2 more

Other study objectives

Asthma-related controller and rescue medication use

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 6Eligibility criteria met