Personalized Treatment Algorithms for Difficult-to-treat Asthma

• Status: Completed
• Trial end date: 2019-10-03
• Target enrollment: 0
• Participant gender: All

Summary

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Azithromycin; Beclomethasone; Budesonide; Cetirizine; Cholecalciferol; Emollients; Fluticasone; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Histamine Antagonists; Histamine H1 Antagonists; Loratadine; Mometasone Furoate; Salmeterol Xinafoate; Tiotropium Bromide; Vitamin D; Xhance

Criteria

Inclusion Criteria:

• History of provider-diagnosed asthma

• Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:

• NAEPP step 3-4 with one of the following criteria in the past 12 months:

• Two Asthma Control Test (ACT) scores <20

• 1 Urgent Care or Emergency Department visit or hospitalization for asthma

• >2 prednisone bursts

• NAEPP step 5-6

• Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance

• Reside at a primary home on average 5 out of 7 days a week.

• Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.

Exclusion Criteria:

• Received biologic therapy 6 months prior to enrollment

• Received systemic steroids 6 weeks prior to enrollment

• Active chronic disease apart from asthma or allergic disease

• Co-morbid lung disease

• Dependence on immunosuppressive drugs for a condition other than asthma

• Participant is pregnant

• Has a severe bleeding disorder

• Has significant developmental disability

• Share a bedroom with a currently enrolled Breath Warriors study participant