Table 4b. Inhaled Corticosteroids: Selected Clinical Data

Last Updated: October 19, 2021

The clinical trials described in this table do not represent all the trials that the Panel reviewed while developing the recommendations for inhaled corticosteroids. The studies summarized below are those that have had the greatest impact on the Panel’s recommendations.

Table 4b. Inhaled Corticosteroids: Selected Clinical Data
Methods Results Limitations and Interpretation
PRINCIPLE: Open-Label, RCT of Inhaled Budesonide in Nonhospitalized Patients With COVID-191
Key Inclusion Criteria:
  • Aged ≥65 years or aged ≥50 years with comorbidities
  • PCR-confirmed or suspected COVID-19
  • ≤14 days of symptoms

Key Exclusion Criteria:

  • Already taking inhaled or systemic corticosteroids
  • Unable to use an inhaler
  • Use of inhaled budesonide contraindicated

Interventions

  • Usual care plus budesonide 800 mcg inhaled twice daily for 14 days (n = 1,069)
  • Usual care (n = 787)

Primary Endpoints:

  • COVID-19-related hospitalization or death up to 28 days from randomization
  • Time to reported recovery up to 28 days from randomization

Participant Characteristics:

  • Mean age 64.2 years; 52% women; 92% White
  • 81% with comorbidities
  • Median of 6 days from symptom onset to randomization

Primary Outcomes:

  • COVID-19-related hospitalization or death within 28 days: 6.8% in budesonide arm vs. 8.8% in usual care arm (OR 0.75; 95% CrI, 0.55–1.03).
  • Median days to reported recovery: 11.8 in budesonide arm vs. 14.7 in usual care arm (HR 1.21; 95% CrI, 1.08–1.36).
Key Limitations:
  • Open-label trial
  • Primary endpoint of time to reported recovery based on self-report

Interpretation:

  • Inhaled budesonide reduced time to reported recovery but not COVID-related hospitalization or death.
  • The clinical significance of self-reported time to recovery in an open-label study is unclear.
STOIC: Open-Label, Phase 2, RCT of Inhaled Budesonide in Nonhospitalized Adults with Early COVID-192
Key Inclusion Criteria:
  • Aged ≥18 years
  • ≤7 days of symptoms

Key Exclusion Criteria:

  • Use of inhaled or systemic glucocorticoids in past 7 days
  • Known allergy or contraindication to budesonide

Interventions:

  • Usual care plus budesonide 800 mcg inhaled twice daily until symptom resolution (n = 73)
  • Usual care (n = 73)

Primary Endpoint:

  • COVID-19-related urgent care visit, including ED visit or hospitalization

Participant Characteristics:

  • Mean age 45 years; 58% women
  • 9% with CVD; 5% with diabetes
  • 95% with positive SARS-CoV-2 RT-PCR result
  • Median of 3 days from symptom onset to randomization

Primary Outcomes:

  • Median days of budesonide use: 7.
  • COVID-19-related urgent care visits or hospitalizations: 1% in budesonide arm vs.14% in usual care arm (relative risk reduction 91%).
Key Limitations:
  • Small, open label trial
  • Early termination after statistical analysis determined that additional participants would not alter outcome

Interpretation:

  • In adult outpatients with mild COVID-19, inhaled budesonide may reduce the need for urgent care or ED assessment and/or hospitalization.