Early COPD Exacerbation Treatment with Combination of ICS and LABA for Patients Presenting with Mild-to-Moderate Worsening of Dyspnea

COPD. 2016 Aug;13(4):439-47. doi: 10.3109/15412555.2015.1101435. Epub 2016 Jan 11.


This is a proof of concept study that aims to establish feasibility and safety of a new strategy that includes an action plan for early treatment of acute exacerbations of COPD (AECOPD) with doubling dose of a combination of a long-acting beta2 agonist and an inhaled corticosteroid, and to explore its potential for avoiding the requirement of prednisone and its safety. Thirty-seven COPD outpatients with previous exacerbations were enrolled and followed-up for 12 months. The written action plan included a standing prescription to be used in the event of an AECOPD: Antibiotic, for 5 days (for purulent exacerbations) and doubling a combination of Salmeterol and Fluticasone Propionate for 10 days. The primary outcome was "treatment success" defined as "no need of prednisone within 30 days of the onset." Twenty-seven patients experienced an AECOPD and doubled their combination dose. Among the 27 patients, there were 21 patients (78%) who did not require prednisone, and none of those had cardiovascular events, pneumonia, ER and hospital admissions. We have assessed that an early treatment of AECOPD with doubling the dose of a combination of Salmeterol and Fluticasone Propionate appears to be safe, well-tolerated and adhered to, and results in no requirement of systemic corticosteroid in a large proportion of patients presenting with mild-to-moderate worsening of dyspnea. This trial has the potential to change the approach of treatment of AECOPD and reduce the use of oral corticosteroids.

Trial registration: ClinicalTrials.gov NCT02136875.

Keywords: action plan; emergency visits; hospital admissions; inhaled therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists / administration & dosage*
  • Aged
  • Anti-Bacterial Agents / therapeutic use*
  • Clinical Protocols
  • Disease Progression
  • Dyspnea / etiology
  • Early Medical Intervention
  • Feasibility Studies
  • Female
  • Fluticasone-Salmeterol Drug Combination / administration & dosage*
  • Glucocorticoids / administration & dosage*
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Proof of Concept Study
  • Pulmonary Disease, Chronic Obstructive / complications
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Severity of Illness Index


  • Adrenergic beta-2 Receptor Agonists
  • Anti-Bacterial Agents
  • Fluticasone-Salmeterol Drug Combination
  • Glucocorticoids

Associated data

  • ClinicalTrials.gov/NCT02136875