Upper Respiratory Tract InfectionPhase 4NCT01326494
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
A Phase 4 study testing Arm 1 Oral Cortico Steroids in people with Upper Respiratory Tract Infection and Asthma, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Upper Respiratory Tract Infection, Asthma
- What is being tested?
- Arm 1 Oral Cortico Steroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to May 2021
- Phase
- Phase 4
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2 or more presentations to Emergency department in a 12 month period
Who cannot join
- less then 2 presentations to Emergency department in a 12 month period
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.
Read the detailed description
In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.
Experts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.
The criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital
- Conditions
- Upper Respiratory Tract Infection, Asthma
- Being tested
- Arm 1 Oral Cortico Steroids
- Keywords
- Upper Respiratory Tract Infection, Asthma, URTI induced exacerbation of Asthma
- Medical subject headings
- Respiratory Tract Infections, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Oral Cortico SteroidsDrug
Also called Prednisone
Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.
Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Oral Cortico Steroid | Active comparator | A filled prescription will be given to be used upon early onset of symptoms. Receives: Drug: Arm 1 Oral Cortico Steroids |
| Usual care for Asthma treatment | No intervention | monitor the readmission of URTI induced asthma in children over a 12 month period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of representation to Health Services for Exacerbation of URTI induced asthma
To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Carleton, University of British Columbia
- Investigators
- Bruce Carleton, B.Pharm, Pharm.D., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326494
- Sponsor's protocol ID
- H10-00184
- Status last verified
- May 2021
- First submitted
- 29 Mar 2011
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
- ClinicalTrials.gov ID
- NCT01326494
- Acronym / sponsor ID
- H10-00184
- Conditions
- Upper Respiratory Tract Infection, Asthma
- Keywords
- Upper Respiratory Tract Infection, Asthma, URTI induced exacerbation of Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 31 Mar 2011 (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 investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.
Detailed description
In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.
Experts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.
The criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Oral Cortico Steroid | Active comparator | Drug: Arm 1 Oral Cortico SteroidsA filled prescription will be given to be used upon early onset of symptoms. |
| Usual care for Asthma treatment | No intervention | –monitor the readmission of URTI induced asthma in children over a 12 month period |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 2 or more presentations to Emergency department in a 12 month period
Key exclusion criteria (1 listed)
- less then 2 presentations to Emergency department in a 12 month period
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 |
|---|---|---|
| Arm 1 Oral Cortico SteroidsAlso: PrednisonePrednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs. Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs ) | Drug | Arm 1 Oral Cortico Steroid |
Primary outcome
Reduction of representation to Health Services for Exacerbation of URTI induced asthma
Time frame: One year
To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.
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 14 May 2021.
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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.
Bruce Carleton, B.Pharm, Pharm.D. principal investigator
The University of British Columbia
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 Arm 1 Oral Cortico Steroids in people with Upper Respiratory Tract Infection and Asthma, run by University of British Columbia 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 1 inclusion and 1 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 14 May 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 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. 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?
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?
Reduction of representation to Health Services for Exacerbation of URTI induced asthma (time frame: One year). 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 14 May 2021.