DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations

NCT06833814 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-4274
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma Exacerbations

Keywords

asthma exacerbation; prednisone; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Enrollment rate

  Period of time needed to recruit the total number of subjects.

  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.

  9 months

Secondary Outcomes (5)

• Safety outcome: emergency room visits

  14 days

• Safety outcomes: Hospitalization

  14 days

• Safety outcomes: Unscheduled medical visits

  14 days

• Safety outcomes: increased or prolonged OCS dose

  14 days

• Safety outcomes: New or increase antibiotics

  14 days

Other Outcomes (1)

• Success rate

  14 days

Study Arms (3)

Small-dose short-course

EXPERIMENTAL

3 days of 50 mg of prednisone followed by 7 days of placebo

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

Drug: Prednisone

High-dose long-course

ACTIVE COMPARATOR

5 days of 50 mg of prednisone and 5 days of 25 mg of prednisone

Drug: Prednisone

Interventions

Prednisone DRUG

Either 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days

High-dose long-course; Small-dose short-course; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female volunteers
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andréanne Côté: lead

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andréanne Côté, MD-MSc

  IUCPQ-UL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andréanne Côté, MD-MSc

CONTACT

14186564747; andreanne.cote.@criucpq.ulaval.ca

Marie-Eve Boulay, MSc

CONTACT

418-656-8711; marie-eve.boulay@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Respirologist-intensivist

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 19, 2025
• Study Start: February 17, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02