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Corticosteroid

Albuterol + Budesonide for Asthma (DARWIN Trial)

Phase 4

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of asthma by a prescribing health care professional

Expectation to use rescue inhaler ≥ 2 days per week

Must not have

Concurrent respiratory disease other than allergic rhinitis

Medical history of life-threatening asthma including intubation and intensive care unit admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to see if using albuterol/budesonide together is better than just using albuterol in treating mild asthma in adults. The study will last for up to

Who is the study for?

This trial is for adults with mild asthma who need to manage inflammation and symptoms. Participants should be able to commit to a study duration of up to 15 weeks, including clinic visits and video calls.

What is being tested?

The study is testing the effectiveness of two treatments: albuterol alone versus a combination of albuterol/budesonide. It focuses on how these treatments affect airway inflammation, control asthma symptoms, and reduce the need for rescue therapy over 12 weeks.

What are the potential side effects?

Possible side effects may include throat irritation, coughing, headaches, or an upset stomach from albuterol; budesonide might cause oral thrush or hoarseness. Each person's reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma by a doctor.

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I expect to use my rescue inhaler at least 2 days a week.

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I am not able to have children or I am using effective birth control.

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I've needed emergency medication at least twice a week for the last 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition that is not just allergies.

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I have had severe asthma attacks that required breathing support and ICU care.

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I may need corticosteroids for a condition other than asthma during treatment.

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I have smoked for more than a year but less than or equal to 10 pack-years.

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My cancer has been in remission for less than a year.

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I have other health conditions that are not well-managed with current treatments.

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I am using an inhaler that contains steroids for my lung condition.

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I haven't used any corticosteroids in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline to maximum value of daily morning FeNO

Secondary study objectives

Change from baseline in FeNO on high inflammation days

Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment

Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate)

+2 more

Other study objectives

Number of SAEs and DAEs

Awards & Highlights

Pivotal Trial

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

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 - Participants randomized to receive albuterol/budesonideExperimental Treatment1 Intervention

Participants will be randomized based on Visit 1 FeNO levels (\< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.

Group II: Group 2 - Participants randomized to receive albuterolActive Control1 Intervention

0 / 12Eligibility criteria met