Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations
Brief Summary: Asthma imposes a significant burden in the US 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 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. The Investigators 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. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies 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 we demonstrated that implementing PARTICS improves important asthma outcomes such as reducing exacerbations. The Investigators have designed a study with the stakeholders to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard of care through the Asthma IQ system. The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ciclesonide | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ciclesonide | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ciclesonide | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Ciclesonide; Assigned to Arm(s): 1, 2, 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
B: Arm Label: Sequence #1; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Arm Label: Sequence #2; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Arm Label: Sequence #3; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Arm Label: Sequence #4; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Arm Label: Sequence #5; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Arm Label: Sequence #6; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate + montelukast, Drug: fluticasone propionate, Drug: fluticasone propionate + salmeterol | Intervention Type: DRUG; Name: fluticasone propionate + montelukast; Assigned to Arm(s): Sequence #1, Sequence #2, Sequence #3, Sequence #4, Sequence #5, Sequence #6 | Intervention Type: DRUG; Name: fluticasone propionate; Assigned to Arm(s): Sequence #1, Sequence #2, Sequence #3, Sequence #4, Sequence #5, Sequence #6 | Intervention Type: DRUG; Name: fluticasone propionate + salmeterol; Assigned to Arm(s): Sequence #1, Sequence #2, Sequence #3, Sequence #4, Sequence #5, Sequence #6
C: Arm Label: PARTICS; Type: ACTIVE_COMPARATOR; Interventions: Drug: PARTICS using QVAR | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: PARTICS using QVAR; Assigned to Arm(s): PARTICS
D: Arm Label: Daily ICS + Rescue ICS; Type: EXPERIMENTAL; Interventions: Drug: Beclomethasone dipropionate, Drug: Albuterol sulfate | Arm Label: Daily ICS; Type: ACTIVE_COMPARATOR; Interventions: Drug: Beclomethasone dipropionate, Drug: Albuterol sulfate | Arm Label: Rescue ICS; Type: EXPERIMENTAL; Interventions: Drug: Beclomethasone dipropionate, Drug: Albuterol sulfate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Albuterol sulfate | Intervention Type: DRUG; Name: Beclomethasone dipropionate; Assigned to Arm(s): Daily ICS, Daily ICS + Rescue ICS | Intervention Type: DRUG; Name: Beclomethasone dipropionate; Assigned to Arm(s): Daily ICS + Rescue ICS, Rescue ICS | Intervention Type: DRUG; Name: Albuterol sulfate; Assigned to Arm(s): Daily ICS, Daily ICS + Rescue ICS, Placebo, Rescue ICS

Answer: C