Symptom Clusters in Children With Exacerbation-prone Asthma

Asthma in Children Clinical Trial

Official title:

Symptom Clusters in Children With Exacerbation-prone Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04002362
• Other study ID #: IRB00111087
• Secondary ID: R01NR018666
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: Anne Fitzpatrick, PhD
• Phone: 404-727-9112
• Email: anne.fitzpatrick[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection of triamcinolone acetonide and will be followed for 48 weeks. The study visit 2 weeks after the injection will assess the response to the study medication, while the remaining study visits will examine the temporal stability of the symptom clusters.

Description:

Asthma symptom control is suboptimal in the majority of children in the United States, despite widespread availability of asthma controller medications and standardized treatment guidelines. While deaths from asthma have declined, 53.7% of children with asthma continue to experience an exacerbation each year and the associated public health burden is substantial.

While the factors responsible for poor asthma symptom control are complex and include limited access to care, poor adherence to preventative asthma medications, and exposures to environmental allergens and irritants such as tobacco smoke, it is also recognized that children with exacerbation-prone asthma are a heterogeneous group with differing clinical outcomes and longitudinal disease trajectories. Symptoms (defined as subjective sensations) can also be quite varied within and among affected children. Whereas some children have persistent, troublesome respiratory symptoms, others have respiratory symptoms only with upper respiratory infections. Mental health symptoms and social health symptoms have been inadequately characterized in this population, but some children with asthma also report depression and anxiety and impaired family functioning and relationships that may further worsen asthma outcomes. However, prior studies are limited by a narrow focus on individual symptoms in isolation. To date, there has been no attempt to identify symptom clusters (defined as two or more concurrent symptoms independent of other clusters) in children with exacerbation-prone asthma.

Poor understanding of symptom clusters is a major shortcoming in asthma symptom science. In other chronic disorders such as cancer, compared with a single symptom, symptom clusters of pain, fatigue, sleep disturbance and mood disturbance significantly worsen patient-reported outcomes of functional status and quality of life. There is also emerging evidence that interventions for one symptom within a cluster (i.e., cognitive-behavioral therapy for pain) reduce the severity of other symptoms within that cluster (i.e., fatigue and sleep disturbance). Because children with exacerbation-prone asthma rarely report a single symptom, greater knowledge of the assessment (and ultimately management) of symptom clusters in these children has the potential to significantly improve individualized treatment and clinical outcomes.

The researchers here propose a 48-week cohort study (N=173) to test the overarching hypothesis that symptom clusters and their associated inflammatory and metabolic pathways predict corticosteroid treatment responsiveness (primary objective outcome) and quality of life (patient-reported secondary outcome) in children 8-17 years with exacerbation-prone asthma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 173
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

Inclusion Criteria:

• Age 6 to less than 21 years at the enrollment visit

• Physician diagnosis of asthma

• History of an asthma exacerbation in the previous 12 months, defined as either:

• Treatment with systemic corticosteroids, or

• Increase in rescue medication use (i.e., albuterol or inhaled corticosteroid) for 24 hours or more, or

• One or more missed school days due to asthma symptoms, or

• An unscheduled visit for asthma at either a physician's office, urgent care, hospital emergency room, or

• Hospitalization for asthma.

• In the event of a recent exacerbation treated with systemic corticosteroids or requiring hospitalization, the first study visit will be postponed until two weeks after the last dose of systemic corticosteroids (i.e., prednisone or prednisolone).

Exclusion Criteria:

• Previous allergic reaction to systemic corticosteroids

• Hepatic, biliary, or renal disease that can interfere with drug metabolism/excretion

• Chronic medical disorders that may increase the risk of drug-related injury, including osteogenesis imperfecta (increased risk of fracture with corticosteroids), or Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy)

• Pregnancy

• Current smoking

• Congenital disorders or deformities of the chest wall, lungs or airways

• History of premature birth <35 weeks gestation

• Unwillingness to receive triamcinolone

• Planning to relocate before study completion

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Syndrome

Intervention

Drug:
• Triamcinolone Acetonide
An intramuscular injection of triamcinolone acetonide (1 mg/kg, up to 40 mg maximum) will be administered deep in the gluteal muscle by a trained registered nurse.

Locations

Country	Name	City	State
United States	Children's Healthcare of Altanta	Atlanta	Georgia
United States	Emory Children's Center	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Questionnaire (ACQ) Score	Responsiveness to the study treatment will be assessed with the ACQ. This 7-item questionnaire includes questions related to daytime and nocturnal symptoms, short-acting bronchodilator use, and lung function during the clinic visit on that day. Participants report how difficult their asthma was to control on a scale from 0 (no impairment) to 6 (maximum impairment). Total raw scores range from 0 to 42, with higher scores indicating poorer asthma control.	Baseline, Week 2
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS)	Quality of life will be assessed with the 8-item PAIS instrument. As with all PROMIS measures, the PAIS is scored on the T-score metric, with higher scores reflecting more of the concept being measured. On the T-score metric, 50 is the mean of the reference population and 10 is the standard deviation; thus scores of 40 and 60 are one standard deviation lower and higher than the mean of the reference population, respectively.	Weeks 16, 32, and 48