Effect of budesonide/formoterol pressurized metered-dose inhaler on exacerbations versus formoterol in chronic obstructive pulmonary disease: The 6-month, randomized RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) study.

Abstract

BACKGROUND:

Prevention of exacerbations is a primary goal for chronic obstructive pulmonary disease (COPD) therapy. This randomized, double-blind, double-dummy, parallel-group, multicenter study evaluated the effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing COPD exacerbations.

METHODS:

1219 patients aged ≥40 years with moderate-to-very-severe COPD (per lung function) and a history of ≥1 COPD exacerbation received budesonide/formoterol pMDI 320/9 μg twice daily (BID) during a 4-week run-in. Patients were then randomized 1:1 to receive budesonide/formoterol pMDI 320/9 μg BID (n = 606) or formoterol DPI 9 μg BID (n = 613) for 26 weeks. Exacerbations were identified using predefined criteria for symptom worsening and treatment with systemic corticosteroids and/or antibiotics and/or hospitalization. The primary endpoint was annual rate of exacerbations.

RESULTS:

Budesonide/formoterol pMDI resulted in a 24% reduction in annual rate of exacerbations (0.85 vs 1.12; rate ratio: 0.76 [95% CI: 0.62, 0.92]; P = 0.006), and a significant risk reduction for time to first exacerbation (hazard ratio: 0.78 [95% CI: 0.64, 0.96]; P = 0.016) versus formoterol DPI. The most commonly reported adverse events (AEs; ≥3%) in budesonide/formoterol and formoterol groups were COPD (4.5% vs 8.6%) and nasopharyngitis (5.0% vs 5.2%). Pneumonia AEs were reported in 0.5% and 1.0% of budesonide/formoterol-treated and formoterol-treated patients, respectively.

CONCLUSIONS:

Budesonide/formoterol pMDI is an effective treatment option for reducing exacerbation rates in COPD patients with moderate-to-very-severe airflow limitation and history of exacerbations. No increase in pneumonia was observed with budesonide/formoterol; safety data were consistent with its established profile.

• Authors: Gary T Ferguson, Donald P Tashkin, Tor Skärby, Carin Jorup, Kristina Sandin, Michael Greenwood, Kristine Pemberton, Frank Trudo
• Journal: Respiratory medicine (Respir Med) Vol. 132 Pg. 31-41 (Nov 2017) ISSN: 1532-3064 [Electronic] England
• PMID: 29229103 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Bronchodilator Agents
• Budesonide, Formoterol Fumarate Drug Combination
• Glucocorticoids
• Formoterol Fumarate

Topics

• Administration, Inhalation
• Adult
• Aged
• Aged, 80 and over
• Bronchodilator Agents (administration & dosage, therapeutic use)
• Budesonide, Formoterol Fumarate Drug Combination (administration & dosage, therapeutic use)
• Disease Progression
• Double-Blind Method
• Dry Powder Inhalers
• Female
• Forced Expiratory Volume
• Formoterol Fumarate (administration & dosage, therapeutic use)
• Glucocorticoids (administration & dosage, therapeutic use)
• Humans
• Male
• Metered Dose Inhalers
• Middle Aged
• Proportional Hazards Models
• Pulmonary Disease, Chronic Obstructive (drug therapy, physiopathology)
• Severity of Illness Index
• Treatment Outcome
• Vital Capacity