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Symptom Clusters in Children With Exacerbation-prone Asthma

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ClinicalTrials.gov Identifier: NCT04002362
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Anne M Fitzpatrick PhD, Emory University

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04002362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Symptom Clusters in Children With Exacerbation-prone Asthma
Official Title  ICMJE Symptom Clusters in Children With Exacerbation-prone Asthma
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma in Children
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
173
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 8 to less than 18 years at the enrollment visit
  • Physician diagnosis of asthma
  • History of an asthma exacerbation treated with systemic corticosteroids in the previous 12 months

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne Fitzpatrick, PhD 404-727-9112 anne.fitzpatrick@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002362
Other Study ID Numbers  ICMJE IRB00111087
R01NR018666 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be available for sharing, after deidentification.
Supporting Materials: Study Protocol
Time Frame: Data will be made available for sharing three months following publication, with no end date.
Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the proposal. Proposals should be directed to anne.fitzpatrick@emory.edu. To gain access, data requestors will need to sign a data access agreement.
Responsible Party Anne M Fitzpatrick PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Anne Fitzpatrick, PhD Emory University
PRS Account Emory University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP