Asthma in Children Clinical Trial
Official title:
Albuterol Integrated Adherence Monitoring in Children With Asthma
Verified date | November 2023 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the Children's Hospital of Los Angeles
Status | Completed |
Enrollment | 21 |
Est. completion date | June 22, 2022 |
Est. primary completion date | June 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 18 Years |
Eligibility | Inclusion Criteria: - Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment. Exclusion Criteria: - Patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or Age < 4 (ProAir® Digihaler only approved for Subjects 4 years and older). Patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc). |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | Teva Pharmaceuticals USA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma Outcomes | Severity by NHLBI EPR3 Guidelines | 3 months | |
Primary | Asthma Adherence | 4-item Morisky Medication Adherence Scale (MMAS-4) | 3 months | |
Primary | Asthma Adherence | Test of Adherence to Inhalers (TAI) | 3 months | |
Primary | Asthma Outcomes | Composite Asthma Severity Index (CASI) | 3 months | |
Primary | Asthma Outcomes | Asthma Control Test (ACT) | 3 months | |
Primary | Albuterol Use | Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc. | 3 months | |
Secondary | Spirometry | Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow. | 3 months | |
Secondary | Lung Function | Microlife FEV1, measures FEV1 | 3 months | |
Secondary | Asthma Quality of Life | PedsQL (Pediatric Quality of Life Inventory) | 3 months |
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