Efficacy of As-Needed Budesonide-Formoterol in Mild Asthma Management

Introduction

An open-label clinical trial was conducted to investigate budesonide-formoterol reliever therapy used on an as-needed basis among adults with mild asthma who had been treated with only as-needed short-acting ?₂-agonist (SABA).

Method

Patient Profile

Patients (n: 668; age: 18–75 years) with diagnosis of asthma, who used as-needed SABA.

Study Design

Patients were randomly assigned to three groups.

• Albuterol group: 100 ?g of albuterol, two inhalations from a pressurized metered-dose (PMD) inhaler as needed for symptom relief.
• Budesonide maintenance group: 200 ?g of budesonide, one inhalation twice-daily, plus albuterol 100 ?g, two inhalations from PMD as needed.
• Budesonide-formoterol group: 200 ?g of budesonide and 6 ?g of formoterol, one inhalation as needed for symptom relief.

Endpoints

Primary Endpoints

• Annualized rate of asthma exacerbations per patient.

Secondary Endpoints

• Number of exacerbations
• Number of patients withdrawn due to treatment failure
• Score on the Asthma Control Questionnaire-5
• On-treatment FEV1 and FENO
• Adverse events.

Results

• Patients receiving as-needed budesonide-formoterol reported a significantly lower exacerbation rate per patient per year (0.195) compared to as-needed salbutamol group (0.400), which did not differ significantly from those in the budesonide maintenance group (0.175).

• The number of severe exacerbations was lowest in the budesonide-formoterol group (9) compared to as needed salbutamol group (23) and budesonide maintenance group (21).
• The dose of budesonide was also less in the budesonide-formoterol group.

Conclusions

• Budesonide-formoterol combination is better for reducing the risk of exacerbations and in controlling severe exacerbations.
• Low FENO in budesonide-formoterol therapy suggested that it has anti-inflammatory activity in the airway when administered according to an as-needed reliever regimen for the treatment of mild asthma.
• Budesonide-formoterol used as needed was superior in preventing exacerbations in adults with mild asthma compared to as-needed albuterol.

N Engl J Med 2019; 380:2020-2030.