Symptom Clusters in Children With Exacerbation-prone Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04002362|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma in Children||Drug: Triamcinolone Acetonide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||173 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Symptom Clusters in Children With Exacerbation-prone Asthma|
|Actual Study Start Date :||November 13, 2019|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Experimental: Children receiving triamcinolone acetonide
Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection of triamcinolone acetonide and will be followed for 48 weeks.
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.
Other Name: Kenalog
- Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline, Week 2 ]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.
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) [ Time Frame: Weeks 16, 32, and 48 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002362
|Contact: Anne Fitzpatrick, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Children's Healthcare of Altanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Emory Children's Center||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Anne Fitzpatrick, PhD||Emory University|