AsthmaNCT00973687
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
A study testing Ora Sweet and Dexamethasone in people with Asthma, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ora Sweet and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- acute asthma exacerbation
- requiring oral systemic corticosteroids for management
Who cannot join
- preference for pills over liquid formulation
- history of Nissen fundoplication surgery
- needed immediate airway intervention
- require oral medications to be given via a G or J tube
- if patient care would be compromised
- enrolled in the study on a previous visit.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.
- Conditions
- Asthma
- Being tested
- Ora Sweet, Dexamethasone
- Keywords
- pediatric, dexamethasone, management, corticosteroids, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ora SweetDrug
A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 10 mg/mL Unsweetened Formulation | Placebo comparator | no prior vomiting Receives: Drug: Dexamethasone |
| 1 mg/mL Ora Sweet Formulation | Experimental | no prior vomiting Receives: Drug: Ora Sweet; Drug: Dexamethasone |
| 10 mg/mL Unsweetened with prior vomiting | Active comparator | with prior vomiting Receives: Drug: Dexamethasone |
| 1 mg/mL Ora Sweet with prior vomiting | Experimental | with prior vomiting Receives: Drug: Ora Sweet; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
Measured: During Emergency Department visit
Secondary outcomes (1)
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
Measured: 7-14 days following emergency dept visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Foundation
- Investigators
- Lyn K Sonnenberg, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973687
- Sponsor's protocol ID
- 2967
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
- ClinicalTrials.gov ID
- NCT00973687
- Acronym / sponsor ID
- 2967
- Conditions
- Asthma
- Keywords
- pediatric, dexamethasone, management, corticosteroids, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- IWK Foundation
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 mg/mL Unsweetened Formulation | Placebo comparator | Drug: Dexamethasoneno prior vomiting |
| 1 mg/mL Ora Sweet Formulation | Experimental | Drug: Ora Sweet, Drug: Dexamethasoneno prior vomiting |
| 10 mg/mL Unsweetened with prior vomiting | Active comparator | Drug: Dexamethasonewith prior vomiting |
| 1 mg/mL Ora Sweet with prior vomiting | Experimental | Drug: Ora Sweet, Drug: Dexamethasonewith prior vomiting |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- acute asthma exacerbation
- requiring oral systemic corticosteroids for management
Key exclusion criteria (6 listed)
- preference for pills over liquid formulation
- history of Nissen fundoplication surgery
- needed immediate airway intervention
- require oral medications to be given via a G or J tube
- if patient care would be compromised
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 |
|---|---|---|
| Ora SweetA pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes. | Drug | 1 mg/mL Ora Sweet Formulation, 1 mg/mL Ora Sweet with prior vomiting |
| Dexamethasone | Drug | 1 mg/mL Ora Sweet Formulation, 1 mg/mL Ora Sweet with prior vomiting, 10 mg/mL Unsweetened Formulation, 10 mg/mL Unsweetened with prior vomiting |
Primary outcome
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
Time frame: During Emergency Department visit
1 secondary outcome
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
Time frame: 7-14 days following emergency dept visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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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.
Lyn K Sonnenberg, MD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ora Sweet and Dexamethasone in people with Asthma, run by IWK Health Centre at 1 site in Canada.
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 2 inclusion and 6 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 26 Aug 2015. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma. (time frame: During Emergency Department visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2015.