Clinical trial NCT06833814: DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations
Official title: DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations: A Parallel, Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Asthma Exacerbations
Keywords: asthma exacerbation
prednisone
randomized controlled trial
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Enrollment rate
timeFrame: 9 months
measure: Acceptability
timeFrame: 9 months
Secondary outcomes:
measure: Safety outcome: emergency room visits
timeFrame: 14 days
measure: Safety outcomes: Hospitalization
timeFrame: 14 days
measure: Safety outcomes: Unscheduled medical visits
timeFrame: 14 days
measure: Safety outcomes: increased or prolonged OCS dose
timeFrame: 14 days
measure: Safety outcomes: New or increase antibiotics
timeFrame: 14 days
Other outcomes:
measure: Success rate
timeFrame: 14 days
Locations:
Study officials:
affiliation: IUCPQ-UL
name: Andréanne Côté, MD-MSc
role: PRINCIPAL_INVESTIGATOR
References: