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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Asthma Exacerbations
• Intervention / Treatment: Drug: Prednisone

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Andréanne Côté, MD-MSc; Phone Number: 14186564747; Email: andreanne.cote.@criucpq.ulaval.ca
• Study Contact Backup: Name: Marie-Eve Boulay, MSc; Phone Number: 418-656-8711; Email: marie-eve.boulay@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small-dose short-course; 3 days of 50 mg of prednisone followed by 7 days of placebo	Drug: Prednisone; Either 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days
Active Comparator: Usual care; 3 days of 50 mg of prednisone and 4 days of 25 mg of prednisone followed by 3 days of placebo	Drug: Prednisone; Either 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days
Active Comparator: High-dose long-course; 5 days of 50 mg of prednisone and 5 days of 25 mg of prednisone	Drug: Prednisone; Either 150 mg over 3 days or 250 mg over 7 days or 350 mg over 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome: emergency room visits	Did the participant go to the emergency room visit between day of exacerbation and day 14.	14 days
Safety outcomes: Hospitalization	Was the patient hospitalized between day of exacerbation and day 14?	14 days
Safety outcomes: Unscheduled medical visits	Did the participant go for an unscheduled medical visit between day of exacerbation and day 14?	14 days
Safety outcomes: increased or prolonged OCS dose	Has the participant had to increase or prolong his OCS dose?	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?	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Success parameters will include increased or prolonged OCS dose, re consultation for OCS, new, increased or prolonged antibiotics, change in ACQ6 score between baseline and 14 days, and change in FEV1 between baseline and 14 days.	14 days

Collaborators and Investigators

• Sponsor: Andréanne Côté
• Investigators: Principal Investigator: Andréanne Côté, MD-MSc, IUCPQ-UL

Study record dates

Study Major Dates

• Study Start (Estimated): February 17, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; asthma exacerbation; prednisone
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 2025-4274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No