| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
| Ages Eligible for Study: | 8 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Anne Fitzpatrick, PhD | 404-727-9112 | anne.fitzpatrick@emory.edu |
| 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 |
| Tracking Information | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||||
| Last Update Posted Date | December 17, 2020 | ||||||||||
| 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 |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
| Change History | |||||||||||
| Current Secondary Outcome Measures ICMJE |
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.
|
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| 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 | Allocation: N/A 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
|
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| Publications * | Not Provided | ||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 8 Years to 17 Years (Child) | ||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||
| Contacts ICMJE |
|
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| 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 ) |
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| Has Data Monitoring Committee | No | ||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Anne M Fitzpatrick, Emory University | ||||||||||
| Study Sponsor ICMJE | Emory University | ||||||||||
| Collaborators ICMJE | National Institute of Nursing Research (NINR) | ||||||||||
| Investigators ICMJE |
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| PRS Account | Emory University | ||||||||||
| Verification Date | December 2020 | ||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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