Comparing Ways to Decrease Severe Asthma Attacks among Black and Latinx Adults with Moderate to Severe Asthma -- The PREPARE Study

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What was the research about?

People with asthma may have asthma attacks that make it hard to breathe. Symptoms may include shortness of breath, tightness in the chest, coughing, or wheezing. People may need treatment with steroids when they have severe attacks, and they may also end up in the hospital. Black and Latinx people have worse asthma outcomes compared with White people.

Using an inhaler with a medicine called an inhaled corticosteroid, or ICS, every day can help control asthma. To ease asthma symptoms when they occur, people can take a fast-acting asthma medicine through a reliever inhaler or a nebulizer. With a nebulizer, patients inhale medicine through a mask. Using the ICS inhaler at the same time as the reliever inhaler or nebulizer is one way to prevent and control asthma attacks.

In this study, the research team wanted to see if adding PARTICS, or Patient-Activated Reliever-Triggered Inhaled Corticosteroid, to usual asthma care improved outcomes for Black and Latinx patients. In PARTICS, patients take one puff of an ICS inhaler each time they take a puff of their reliever inhaler. If patients use a nebulizer, they take five puffs of an ICS inhaler.

What were the results?

At 15 months, compared with patients who continued usual care alone, patients who added PARTICS to usual asthma care had:

• Fewer severe asthma attacks 
• Better asthma control 
• Better quality of life
• Fewer missed days of school or work and fewer missed usual activities

Who was in the study?

The study included 1,201 patients ages 18–75 with moderate to severe asthma. Of these, 50 percent were Black, and 50 percent were Latinx. The average age was 48, and 84 percent were women. All had asthma for at least one year and received care from one of 19 clinics across the United States. The study included people who do and don’t smoke, as well as those who used to smoke.

What did the research team do?

The research team assigned patients by chance to add PARTICS to usual care or continue usual care alone. Usual care included routine asthma treatment. All patients watched an educational video about asthma. Patients assigned to add PARTICS watched a video about how and why to use PARTICS. The team also provided ICS inhalers to patients assigned to use PARTICS.

At the start of the study and each month for 15 months, patients completed surveys about asthma.

Black and Latinx patients with asthma, doctors, and people from asthma patient advocacy and professional groups provided input during the study.

What were the limits of the study?

Most people in the study were women. Results may differ for people of other genders.

Future research could compare the effectiveness of PARTICS versus single-maintenance and reliever therapy, or SMART, which uses one inhaler every day.

How can people use the results?

Doctors and patients with asthma can use the results when considering ways to control asthma.

Objective

To compare the effectiveness of adding a Patient-Activated Reliever-Triggered Inhaled Corticosteroid (PARTICS) to usual care versus usual care alone in reducing annual asthma exacerbations among Black and Latinx adults with moderate to severe asthma

Study Design

This pragmatic randomized controlled trial compared the effectiveness of two asthma therapy strategies in reducing the rate of asthma exacerbations among Black and Latinx adults.

During an in-person clinic visit, researchers randomly assigned patients to usual asthma care with or without PARTICS. All patients continued their usual asthma treatment and viewed an educational video about asthma. Researchers instructed patients assigned to PARTICS that when using their reliever inhaler, they should also take one puff of an inhaled corticosteroid for each puff of the reliever inhaler. If they used a nebulizer instead, they should also take five puffs of an inhaled corticosteroid. The study provided the inhaled corticosteroid for patients assigned to PARTICS.

The study included 1,201 adults ages 18–75 with clinician-diagnosed moderate to severe asthma. Of these adults, 50% were Black, and 50% were Latinx. The average age was 48, and 84% were female. All received care from one of 19 clinics across the United States. The study included people who used to smoke or who currently smoke, as well as people who do not smoke.

At baseline and then monthly for 15 months, patients completed surveys about study outcomes.

Black and Latinx patients with asthma, clinicians, and representatives from asthma advocacy groups and professional organizations provided input prior to and during the study.

Results

At 15 months, compared with patients who continued usual care alone, patients who added PARTICS had a lower annualized rate of asthma exacerbations (0.69 versus 0.82; hazard ratio=0.85; 95% confidence interval: 0.72, 0.999; p= 0.048). 

Compared with patients who continued usual care alone, patients who added PARTICS had improved asthma control (3.4 points versus 2.5 points; p<0.001) and quality of life (0.12 points versus 0.08 points; p<0.001) and had fewer days of work, school, or usual activities missed per year (13.4 days versus 16.8 days; p=0.013).

Limitations

Most study participants were women. Results may differ for others.

Conclusions and Relevance

In this study, Black and Latinx adults instructed to use PARTICS with their usual asthma therapy had lower rates of asthma exacerbations, improved asthma control and quality of life, and fewer missed days of work, school, or usual activities compared with those who continued usual asthma care alone.

Future Research Needs

Future research could compare the use of PARTICS with guideline-recommended single maintenance and reliever therapy (SMART) in a comparative effectiveness trial.