COPD: Real-world Safety and Efficacy of Budesonide-Formoterol Vs Fluticasone-Salmeterol

Pavankumar Kamat


November 18, 2021


  • Budesonide-formoterol inhaler was as effective as fluticasone-salmeterol in reducing the incidence of moderate-severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) who had ≥1 exacerbation in the year prior to treatment initiation.

  • However, budesonide-formoterol was found to be more effective in reducing the incidence of severe exacerbation and pneumonia than fluticasone-salmeterol, particularly in patients with higher blood eosinophil counts.

Why this matters

  • The findings could add a new dimension to treatment recommendations for the use of the initial long-acting beta2-agonist (LABA)-inhaled corticosteroid (ICS) combined inhaler.

Study design

  • The study included 86,224 patients with COPD (age, ≥50 years) who subsequently were new users of a LABA-ICS combination (2002-2018), identified from the UK Clinical Practice Research Datalink.

  • Efficacy outcomes: the occurrence of a first moderate or severe COPD exacerbation during follow-up and the incidence of a severe exacerbation.

  • Safety outcome: the occurrence of first severe pneumonia requiring hospitalisation.

  • Funding: Canadian Institutes of Health Research and the Canadian Foundation for Innovation.

Key results

  • The adjusted HR (aHR) of a first moderate or severe exacerbation with budesonide-formoterol relative to fluticasone-salmeterol was 0.98 (95% CI, 0.95-1.01).

  • Budesonide-formoterol vs fluticasone-salmeterol was associated with a lower risk of severe exacerbation (aHR, 0.92; 95% CI, 0.85-0.99).

  • The aHR of severe pneumonia requiring hospitalisation with budesonide-formoterol was 0.76 (95% CI, 0.70-0.83) which dropped to 0.62 (95% CI, 0.51-0.77) at a blood eosinophil count >300 cells/μL.


  • Study used physician diagnoses to identify patients with COPD, which may have misclassified some patients with asthma.


Suissa S, Dell'Aniello S, Ernst P. Comparing initial LABA-ICS inhalers in COPD: Real-world effectiveness and safety. Respir Med. 2021 Oct 07 [Epub ahead of print];189:106645. doi: 10.1016/j.rmed.2021.106645. PMID: 34757243  View abstract 

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.


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