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AzTrials

Asthma in ChildrenPhase 2NCT04179461

Personalized Treatment Algorithms for Difficult-to-treat Asthma

A Phase 2 study testing Cholecalciferol, antihistamine and Azithromycin in people with Asthma in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Asthma in Children
What is being tested?
Cholecalciferol, antihistamine and Azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
16 Mar 2018to 3 Oct 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • History of provider-diagnosed asthma
  • Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:
  • NAEPP step 3-4 with one of the following criteria in the past 12 months:
  • Two Asthma Control Test (ACT) scores <20
  • 1 Urgent Care or Emergency Department visit or hospitalization for asthma
  • >2 prednisone bursts
Show all 10Show fewer
  • NAEPP step 5-6
  • Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance
  • Reside at a primary home on average 5 out of 7 days a week.
  • Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.

Who cannot join

  • Received biologic therapy 6 months prior to enrollment
  • Received systemic steroids 6 weeks prior to enrollment
  • Active chronic disease apart from asthma or allergic disease
  • Co-morbid lung disease
  • Dependence on immunosuppressive drugs for a condition other than asthma
  • Participant is pregnant
Show all 9Show fewer
  • Has a severe bleeding disorder
  • Has significant developmental disability
  • Share a bedroom with a currently enrolled Breath Warriors study participant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

Read the detailed description

With this study investigators will conduct study visits to determine and quantify known molecular, genetic, genomic, epigenetics, immunologic, and exposure biomarkers that will help elucidate molecular disease endotype within the difficult-to-treat phenotype. This information will be used along with clinical, psychosocial, and adherence data to develop a personalized treatment plan. Following the personalized treatment plan, study clinicians will prescribe the medications through a home delivery or routine pharmacy depending on the family's preference and covered by the participant's health insurance. Investigators will track disease outcome metrics including exacerbations, symptom-free days, and asthma symptom scores to determine the effectiveness of this personalized approach.

Being tested
Cholecalciferol, antihistamine, Azithromycin, emollient cream, Fluticasone Propionate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDrug

    Also called Vitamin D

    Oral administration

  • antihistamineDrug

    Also called cetirizine, loratadine

    Oral administration

  • AzithromycinDrug

    Also called Zithromax

    Oral administration

  • emollient creamDrug

    Topical

  • Fluticasone PropionateDrug

    Also called Flonase Nasal Spray

    Nasal spray

  • Asthma Controller MedicationDrug

    Also called Mometasone/Formoterol, Fluticasone/Salmeterol, Mometasone Furoate, Fluticasone

    Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.

Study groups in NCT04179461
Study groupRoleWhat they receive
Personalized TreatmentExperimentalPersonalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.
Receives: Drug: Cholecalciferol; Drug: antihistamine; Drug: Azithromycin; Drug: emollient cream; Drug: Fluticasone Propionate; Drug: Asthma Controller Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Composite Asthma Severity Index (CASI)

    CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).

    [The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity]

    Measured: Baseline to 12 months

Secondary outcomes (3)

  1. Asthma Control Test (ACT)

    ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).

    [The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma]

    Measured: Baseline to 12 months

  2. Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)

    FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.

    [A lower FEV1/FVC ratio indicates more severe asthma]

    Measured: Baseline to 12 months

  3. Adherence of Asthma Controller Medication

    Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months).

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start16 Mar 2018
  3. Primary completion3 Oct 2019
  4. Study completion3 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study has 3 study phases: baseline, intervention, and observation. Each participant will independently transition through these study phases. Baseline period: Each participant will be given a treatment recommendation according to their asthma severity/control using the National Asthma Education and Prevention Program (NAEPP asthma guidelines). Intervention period: Each participant will be given a personalized treatment plan based on their asthma severity/control during the baseline period, biologic, and environmental factors. Observation period: All participants will be observed for at least 6 months. Investigators will track the participant's personal outcomes (comparing to baseline) for reutilization, symptom-free days, and quality of life.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179461
Sponsor's protocol ID
ARC 7
Status last verified
Jul 2021
First submitted
14 Nov 2019
Last updated
20 Aug 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guilbert TW, Biagini JM, Ramsey RR, Keidel K, Curtsinger K, Kroner JW, Durrani SR, Stevens M, Pilipenko V, Martin LJ, Kercsmar CM, Hommel K, Hershey GKK. Treatment by biomarker-informed endotype vs guideline care in children with difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2022 May;128(5):535-543.e6. doi: 10.1016/j.anai.2022.01.030. Epub 2022 Feb 3.

    PubMed 35123074

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cholecalciferol, antihistamine and Azithromycin in people with Asthma in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Composite Asthma Severity Index (CASI) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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