AsthmaPhase 3R2D2NCT02725008

Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation

A Phase 3 study testing Dexamethasone in people with Asthma, run by Geoffrey W Jara-Almonte at 1 site in United States.

Completed

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

Trial summary

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department. Read more about this study

Who is it for?: Ages 18 months to 20 years
Conditions the study is for: Asthma
What is being tested?: Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Nov 2017
Phase: Phase 3
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 18 months to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Who cannot join

pregnancy
severe chronic cardiac, respiratory, neurological or neuromuscular disease
complete resolution of symptoms after one treatment of beta agonists
severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Methodist Hospital
Brooklyn, New York, 11215

Other trials in United States

About this study

Official title: A Randomized Double Blinded Placebo Controlled Trial of One Versus Two Doses of Oral Dexamethasone for the Treatment of Acute Asthma Exacerbation in the Pediatric Emergency Department (ED)

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Read the detailed description

A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.

Conditions: Asthma
Being tested: Dexamethasone, placebo
Keywords: Asthma, Pediatric, Emergency Department, Dexamethasone, Steroid
Medical subject headings: Asthma, Emergencies

What participants receive

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

DexamethasoneDrug
Also called decadron
placeboDrug
to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone

Study groups in NCT02725008
Study group	Role	What they receive
Control	Active comparator	Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit Receives: Drug: Dexamethasone
Investigational	Experimental	Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit Receives: Drug: Dexamethasone; Drug: placebo

What is being measured

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

Treatment Failure
number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids
Measured: 5 days

Secondary outcomes (1)

Change in Symptom Severity From Day 1 to Day 5
Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5).
Measured: 5 days

Timeline

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

Nov 2015Nov 2017

First posted31 Mar 2016 (estimated)
Study startNov 2015
Primary completionNov 2017
Study completionNov 2017

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.
Other trials for AsthmaStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725008
Sponsor's protocol ID: 714220-1
Acronym: R2D2
Status last verified: Feb 2019
First submitted: 18 Mar 2016
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double Blinded Placebo Controlled Trial of One Versus Two Doses of Oral Dexamethasone for the Treatment of Acute Asthma Exacerbation in the Pediatric Emergency Department (ED)
ClinicalTrials.gov ID: NCT02725008
Acronym / sponsor ID: R2D2 / 714220-1
Conditions: Asthma
Keywords: Asthma, Pediatric, Emergency Department, Dexamethasone, Steroid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Geoffrey W Jara-AlmonteUniversity, hospital or other
Study start: Nov 2015
Primary completion: Nov 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 31 Mar 2016 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Drug: DexamethasonePatients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Investigational	Experimental	Drug: Dexamethasone, Drug: placeboPatients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit

Who may qualify

Ages: 18 months to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Key exclusion criteria (4 listed)

pregnancy
severe chronic cardiac, respiratory, neurological or neuromuscular disease
complete resolution of symptoms after one treatment of beta agonists
severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

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
DexamethasoneAlso: decadron	Drug	Control, Investigational
placeboto be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone	Drug	Investigational

Primary outcome

Treatment Failure
Time frame: 5 days
number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids

1 secondary outcome

Change in Symptom Severity From Day 1 to Day 5
Time frame: 5 days

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	46	37
Investigational	51	39

Primary outcome: Treatment Failure

Time frame: 5 days. Count of participants. Unit: Participants

Measure	Control n = 37	Investigational n = 39
Value	6	3

Control vs Investigational: Odds Ratio (OR): 2.32 (95% CI 0.54 to 10.07), p = 0.3, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of study participation - 5 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	1 of 46 (2.2%)	1 of 46 (2.2%)	0 of 46
Investigational	1 of 51 (2%)	1 of 51 (2%)	1 of 51

Limitations and caveats (from the sponsor): Target enrollment was not reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
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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.

Christopher Kelly, MD principal investigator

New York Presbyterian Brooklyn Methodist Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with Asthma, run by Geoffrey W Jara-Almonte 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 1 inclusion and 4 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 27 Feb 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Feb 2019). 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?

Treatment Failure (time frame: 5 days). 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 NCT02725008.

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 27 Feb 2019.