AsthmaPhase 4NCT03705273
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
A Phase 4 study testing Dexamethasone IV for PO and Dexamethasone crushed tablets in people with Asthma and Croup, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- What is being tested?
- Dexamethasone IV for PO and Dexamethasone crushed tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 2 Oct 2020
- Phase
- Phase 4
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
- Age 1 to 7 years
- Dexamethasone treatment indicated
- No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
- Have not received systemic corticosteroid for current episode prior to enrollment
Who cannot join
- Allergy to dexamethasone or apple sauce and pudding
- Unable to take medication orally
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.
- Being tested
- Dexamethasone IV for PO, Dexamethasone crushed tablets
- Medical subject headings
- Asthma, Croup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone IV for PODrug
Also called Dexamethasone injection
Common pediatric emergency department practice
Dexamethasone crushed tabletsDrug
Also called Dexamethasone oral tablet
Alternative route of administration for patients unable to swallow tablet whole
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone IV for PO | Experimental | Dexamethasone IV for PO solution mixed with sugar syrup to be given orally Receives: Drug: Dexamethasone IV for PO |
| Dexamethasone crushed tablets | Active comparator | Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally Receives: Drug: Dexamethasone crushed tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Nausea
Presence of nausea after medication administration (yes/no) measured by participant self-report
Measured: 1 hour
Secondary outcomes (1)
Number of Participants Requiring Second Dose of Dexamethasone
Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start23 Oct 2018
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Why it stopped: Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald H Arnold, Vanderbilt University Medical Center
- Investigators
- Donald Arnold, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705273
- Sponsor's protocol ID
- 181682
- Status last verified
- Oct 2021
- First submitted
- 9 Oct 2018
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goettel AM, Hanson HR, Overfield J, Thornton C, Arnold DH. Tastes great, less filling! Randomized trial comparing perceived palatability of dexamethasone preparations in children. Ann Allergy Asthma Immunol. 2023 Jan;130(1):114-115. doi: 10.1016/j.anai.2022.09.016. No abstract available.
PubMed 36596609
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup
- ClinicalTrials.gov ID
- NCT03705273
- Acronym / sponsor ID
- 181682
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone IV for PO | Experimental | Drug: Dexamethasone IV for PODexamethasone IV for PO solution mixed with sugar syrup to be given orally |
| Dexamethasone crushed tablets | Active comparator | Drug: Dexamethasone crushed tabletsDexamethasone tablet crushed and placed in apple sauce or pudding to be given orally |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
- Age 1 to 7 years
- Dexamethasone treatment indicated
- No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
- Have not received systemic corticosteroid for current episode prior to enrollment
Key exclusion criteria (2 listed)
- Allergy to dexamethasone or apple sauce and pudding
- Unable to take medication orally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone IV for POAlso: Dexamethasone injectionCommon pediatric emergency department practice | Drug | Dexamethasone IV for PO |
| Dexamethasone crushed tabletsAlso: Dexamethasone oral tabletAlternative route of administration for patients unable to swallow tablet whole | Drug | Dexamethasone crushed tablets |
Primary outcome
Number of Participants With Nausea
Time frame: 1 hour
Presence of nausea after medication administration (yes/no) measured by participant self-report
1 secondary outcome
Number of Participants Requiring Second Dose of Dexamethasone
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36596609Goettel AM, Hanson HR, Overfield J, Thornton C, Arnold DH. Tastes great, less filling! Randomized trial comparing perceived palatability of dexamethasone preparations in children. Ann Allergy Asthma Immunol. 2023 Jan;130(1):114-115. doi: 10.1016/j.anai.2022.09.016. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Arnold, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone IV for PO and Dexamethasone crushed tablets in people with Asthma and Croup, run by Vanderbilt University Medical Center 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Nov 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?
Number of Participants With Nausea (time frame: 1 hour). 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 NCT03705273, 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 8 Nov 2021.