Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief

Asthma imposes a significant burden on the US population in terms of morbidity, costs to
society, individual suffering, loss of productivity and mortality. African Americans (AA) and
Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite introduction
of national guidelines for asthma treatment, the gap between these groups and whites has been
stable or widening. The need for pragmatic research to address the continuing burden is
widely recognized. Patients use asthma reliever inhalers to provide immediate relief of
symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used
regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a
fixed basis, in all but the mildest asthma. However, adherence by patients and implementation
of evidence-based guideline recommendations by clinicians has been poor. Gap analysis
suggests that it is difficult to improve adherence to the current recommendations without
complex and resource-intensive interventions.

Studies have examined symptom-activated use of ICS triggered by use of a reliever medication.
We call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid.
Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in
asthma attacks compared with usual care, while reducing ICS use by half or more. However,
these studies have been performed in pre- selected populations, which represent less than 5%
of patients with asthma. They have been done with repeated education and adherence checks in
both the intervention and control arms.

The investigators have consulted with AA and H/L patients, health care providers, leaders of
professional societies, advocacy groups, health policy leaders, pharmacists, and
pharmaceutical manufacturers. All groups have indicated that asthma decision making would be
changed if it was demonstrated that implementing PARTICS improves important asthma outcomes
such as reducing rates of exacerbations. Together with our partners and stakeholders, the
investigators have designed a study to determine whether PARTICS can improve outcomes that
are important to patients when superimposed on a background provider-educated standard care
through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE:
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim
is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The
primary outcome will be asthma exacerbations which have been shown to be important to patient
and healthcare stakeholders. The secondary outcomes will include additional outcomes
important to patients (i.e. days lost from work or school, asthma control, & asthma quality
of life). The investigators have broad input and involvement from multiple stakeholder groups
in study design, implementation, and commitments for dissemination. AA and H/L patients and
their advocates have been involved and will continue to play a central role in all phases of
the study.

INCLUSION CRITERIA

- Black or Hispanic based on self-identification (Hispanic if identify as both)

- Male and female, ages 18-75 years

- Ability to provide informed consent

- Clinical history consistent with asthma for > 1 year.

- Prescribed ICS as daily maintenance therapy

- Participant must also have an ACT score of 19 or less, or a history of one or more
exacerbations in the past year that required patient report of systemic corticosteroid
use.

EXCLUSION CRITERIA

- Life expectancy less than one year

- Known allergy to the ICS inhaler used in the study

- Having COPD or other chronic lung disease other than asthma; with the exception of the
following:

- Dx of COPD in a never smoker without any other lung disease or any other disease
that might cause airway obstruction such as: Cystic Fibrosis, Connective Tissue
Disease, premature birth, organ transplantation, bronchiectasis, sarcoid, and
obliterative bronchiolitis

- Dx of COPD in former smoker with normal PFTs done after the person quit smoking

- Dx of COPD in current smoker with normal PFTs done in past 24 months

- Dx of COPD IN CURRENT OR FORMER SMOKER with obstruction on PFTs: normal diffusing
capacity in past 24 months and demonstrated reversibility of 12% or more at any
time

- Regular systemic corticosteroid use daily or every other day for any reason—including
asthma or other medical reasons

- Use of systemic corticosteroid, or visit to the doctor's office, emergency department
(ED) or urgent care, or overnight hospitalization for an asthma exacerbation in the
past month (can wait and re-check eligibility after one month)

- Use of biologics (injections or infusion medicines): with the exception of the
following:

- the patient has been on a stable dose of a biologic for at least 6 months and,

- must have had an exacerbation at least 2 months after starting on a biologic to
be considered eligible OR

- must have a current ACT score <=19 to be considered eligible.

- Bronchial thermoplasty less than 6 months ago (can re-check eligibility 6 months after
procedure)

- Another family member living in the same household already enrolled in study