DOSE Trial: Optimal Dose of Oral Corticosteroids to Treat Asthma Exacerbations
Status:
NOT_YET_RECRUITING
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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.