Asthma ExacerbationsPhase 4DOSENCT06833814
DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations
A Phase 4 study testing Prednisone in people with Asthma Exacerbations, run by Andréanne Côté.
Trial summary
Patients with severe asthma frequently experience exacerbations of their disease. The heterogeneity of asthma exacerbations represents a major challenge for patients and healthcare providers, making treatment difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Exacerbations
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2025to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female volunteers
- 18 years of age or older
- Assessed for a severe asthma exacerbation
- Being prescribed OCS for the management of their exacerbation
- Able to comprehend and follow all required study procedures
- Able to understand and give written informed consent and have signed a written informed consent form (ICF) approved by the REB
Who cannot join
- For females, are pregnant, or lactating
- Respiratory comorbidities other than asthma, including bronchiectasis (non-CF) or asthma-COPD overlap (ACO)
- FEV1 <40% of personal best or <1 Li
- OCS-dependent
- Asthma exacerbation in the 4 weeks preceding the study visit
- Concomitant disease, health condition, and/or lifestyle activities that could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease. These include, but are not restricted to: heart failure, previous bipolar decompensation with prednisone, severe blood hypertension, uncontrolled diabetes, pneumonia.
- Unwilling or unable to comply with the study protocol for any other reason
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations: A Parallel, Randomized Controlled Pilot Study
Patients with severe asthma frequently experience exacerbations of their disease. The heterogeneity of asthma exacerbations represents a major challenge for patients and healthcare providers, making treatment difficult. Current guidelines recommend varying doses of short-term oral corticosteroids (OCS) as first-line treatment for asthma exacerbations. However, studies supporting the optimal dose of OCS to treat asthma exacerbations are rare.
This study aims to evaluate the feasibility, acceptability, and safety of a randomized clinical trial with different OCS regimens for patients and physicians. Additionally, evaluate the success rate of different OCS dosages to support power calculations for a non-inferiority trial.
Read more
In this pilot, parallel, randomized, controlled study, patients with severe asthma exacerbation, considered to require treatment with OCS according to physician judgment after a complete evaluation will be randomized to 1) 3 days of 50 mg prednisone followed by 7 days of placebo, 2) 3 days of 50 mg prednisone and 4 days of 25 mg prednisone followed by 3 days of placebo, or 3) 5 days of 50 mg prednisone and 5 days of 25 mg prednisone. Randomized patients will be assessed for daily symptoms and overall perception of well-being, in addition to asthma control, quality of life as well as additional medical visits. Lung function and inflammation will also be measured. Feasibility and acceptability will be defined by a participation rate >80%, while safety will be defined as an increase in OCS doses in <20% of patients in one arm or an emergency room visit in <10% of patients in one arm. Success will be defined as no increased or prolonged doses of OCS, no re-consultation for OCS or escalation to antibiotics, reduction of symptoms, and return of lung function to >80% of its optimal level.
In addition to determining the feasibility and safety of different OCS regimens to treat asthma exacerbations, this trial will help us determine the optimal design for a randomized clinical trial using different OCS regimens. The exacerbation clinic is already operational with 4 to 5 patients/week assessed and treated. We have all the resources on site to carry out this project.
- Conditions
- Asthma Exacerbations
- Being tested
- Prednisone
- Keywords
- asthma exacerbation, prednisone, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Either 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days
| Study group | Role | What they receive |
|---|---|---|
| Small-dose short-course | Experimental | 3 days of 50 mg of prednisone followed by 7 days of placebo Receives: Drug: Prednisone |
| Usual care | Active comparator | 3 days of 50 mg of prednisone and 4 days of 25 mg of prednisone followed by 3 days of placebo Receives: Drug: Prednisone |
| High-dose long-course | Active comparator | 5 days of 50 mg of prednisone and 5 days of 25 mg of prednisone Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Period of time needed to recruit the total number of subjects.
Measured: 9 months
Acceptability
Acceptability for subjects will be defined by the proportion of subjects agreeing to the study whereas acceptability for physicians will be defined by the proportion of subjects for whom the physicians prescribe OCS and is willing to enroll them in the study.
Measured: 9 months
Secondary outcomes (5)
Safety outcome: emergency room visits
Did the participant go to the emergency room visit between day of exacerbation and day 14.
Measured: 14 days
Safety outcomes: Hospitalization
Was the patient hospitalized between day of exacerbation and day 14?
Measured: 14 days
Safety outcomes: Unscheduled medical visits
Did the participant go for an unscheduled medical visit between day of exacerbation and day 14?
Measured: 14 days
Safety outcomes: increased or prolonged OCS dose
Has the participant had to increase or prolong his OCS dose?
Measured: 14 days
Safety outcomes: New or increase antibiotics
Was the participant prescribed new antibiotics treatment or had to increase antibiotics between day of exacerbation and day 14?
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start17 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ExacerbationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andréanne Côté
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andréanne Côté, Laval University
- Investigators
- Andréanne Côté, MD-MSc, Principal investigator, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833814
- Sponsor's protocol ID
- 2025-4274
- Acronym
- DOSE
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations: A Parallel, Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06833814
- Acronym / sponsor ID
- DOSE / 2025-4274
- Conditions
- Asthma Exacerbations
- Keywords
- asthma exacerbation, prednisone, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Andréanne CôtéUniversity, hospital or other
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- 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.
Patients with severe asthma frequently experience exacerbations of their disease. The heterogeneity of asthma exacerbations represents a major challenge for patients and healthcare providers, making treatment difficult. Current guidelines recommend varying doses of short-term oral corticosteroids (OCS) as first-line treatment for asthma exacerbations. However, studies supporting the optimal dose of OCS to treat asthma exacerbations are rare.
This study aims to evaluate the feasibility, acceptability, and safety of a randomized clinical trial with different OCS regimens for patients and physicians. Additionally, evaluate the success rate of different OCS dosages to support power calculations for a non-inferiority trial.
In this pilot, parallel, randomized, controlled study, patients with severe asthma exacerbation, considered to require treatment with OCS according to physician judgment after a complete evaluation will be randomized to 1) 3 days of 50 mg prednisone followed by 7 days of placebo, 2) 3 days of 50 mg prednisone and 4 days of 25 mg prednisone followed by 3 days of placebo, or 3) 5 days of 50 mg prednisone and 5 days of 25 mg prednisone. Randomized patients will be assessed for daily symptoms and overall perception of well-being, in addition to asthma control, quality of life as well as additional medical visits. Lung function and inflammation will also be measured. Feasibility and acceptability will be defined by a participation rate >80%, while safety will be defined as an increase in OCS doses in <20% of patients in one arm or an emergency room visit in <10% of patients in one arm. Success will be defined as no increased or prolonged doses of OCS, no re-consultation for OCS or escalation to antibiotics, reduction of symptoms, and return of lung function to >80% of its optimal level.
In addition to determining the feasibility and safety of different OCS regimens to treat asthma exacerbations, this trial will help us determine the optimal design for a randomized clinical trial using different OCS regimens. The exacerbation clinic is already operational with 4 to 5 patients/week assessed and treated. We have all the resources on site to carry out this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small-dose short-course | Experimental | Drug: Prednisone3 days of 50 mg of prednisone followed by 7 days of placebo |
| Usual care | Active comparator | Drug: Prednisone3 days of 50 mg of prednisone and 4 days of 25 mg of prednisone followed by 3 days of placebo |
| High-dose long-course | Active comparator | Drug: Prednisone5 days of 50 mg of prednisone and 5 days of 25 mg of prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female volunteers
- 18 years of age or older
- Assessed for a severe asthma exacerbation
- Being prescribed OCS for the management of their exacerbation
- Able to comprehend and follow all required study procedures
Key exclusion criteria (7 listed)
- For females, are pregnant, or lactating
- Respiratory comorbidities other than asthma, including bronchiectasis (non-CF) or asthma-COPD overlap (ACO)
- FEV1 <40% of personal best or <1 Li
- OCS-dependent
- Asthma exacerbation in the 4 weeks preceding the study visit
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 |
|---|---|---|
| PrednisoneEither 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days | Drug | High-dose long-course, Small-dose short-course, Usual care |
Primary outcome
Enrollment rate
Time frame: 9 months
Period of time needed to recruit the total number of subjects.
Acceptability
Time frame: 9 months
Acceptability for subjects will be defined by the proportion of subjects agreeing to the study whereas acceptability for physicians will be defined by the proportion of subjects for whom the physicians prescribe OCS and is willing to enroll them in the study.
5 secondary outcomes
Safety outcome: emergency room visits
Time frame: 14 days
Safety outcomes: Hospitalization
Time frame: 14 days
Safety outcomes: Unscheduled medical visits
Time frame: 14 days
Safety outcomes: increased or prolonged OCS dose
Time frame: 14 days
Safety outcomes: New or increase antibiotics
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
Andréanne Côté, MD-MSc principal investigator
IUCPQ-UL
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Asthma Exacerbations, run by Andréanne Côté.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andréanne Côté, MD-MSc (14186564747, andreanne.cote.@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 9 months). The study lists 2 primary outcomes in all. 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 19 Feb 2025.