GOLD 2020 recommends LAMA/LABA as a first-line initial treatment option in symptomatic COPD patients with severe breathlessness^1*

Footnotes

• * Consider if highly symptomatic (eg, CAT >20).¹
• † Consider blood eosinophil count ≥300 cells/μL or in patients with a history of asthma.¹
• ‡ The SPIROMICS study analysed participants with COPD and three years of prospective data (n=1105). Patients were classified according to yearly exacerbation frequency. They characterised participants based on spirometric values obtained after four inhalations each of albuterol 90 μg/inhalation and ipratropium 18 μg/inhalation. The largest group of subjects was GOLD 2, with relatively equal numbers of GOLD 1 and 3 subjects, followed by GOLD 4. Two percent of patients with a broad range of spirometric measurements presented with ≥2 exacerbations in each year of a 3-year follow-up.¹⁴
• § As measured by the Mahler Transition Dyspnoea Index (TDI) focal score at 12 weeks of treatment. Results derived from an analysis of patients with a history of moderate-to-severe COPD (GOLD stage 2-3) in the OTEMTO® studies. The primary endpoints of the OTEMTO® studies were: FEV₁ AUC_0-3h, trough FEV₁, and SGRQ total score.¹⁵
• ¶ Based upon the as-treated population of the WISDOM post-hoc subanalysis (n=2295), 155 patients met all 3 criteria. This post-hoc analysis of the WISDOM study tested whether or not combining blood eosinophil counts and exacerbation history could better identify patients who were more responsive to ICS.¹³
• ** No fixed-dose combination of LAMA/LABA/ICS was available during the WISDOM trial. Triple therapy refers to an open combination¹⁶
• †† Data presented here are mean results in the overall study population^5,6
• ‡‡ SPIOLTO® achieved a 2.1-point improvement and 4.7-point improvement in SGRQ (St. George’s Respiratory Questionnaire) score vs SPIRIVA® and placebo, respectively. The primary endpoints of the OTEMTO® studies were: FEV₁ AUC_0-3h, trough FEV₁, and SGRQ total score. Data represent mean difference from the combined analysis of OTEMTO® 1 and 2.¹⁵
• # 24-hour FEV₁ profiles after 6 weeks of treatment in the VIVACITO® study. p<0.0001 for all comparisons of SPIOLTO® vs monotherapies and placebo.⁵
• ## The primary endpoint of the ENERGITO® trial was FEV₁ AUC_0-12h after 6 weeks of treatment with either once-daily SPIOLTO® RESPIMAT® or twice-daily fluticasone propionate/salmeterol FDC delivered by the Accuhaler®; the secondary endpoints of the study were FEV₁ AUC_0-24h, trough FEV₁, FEV₁, AUC_12-24h, and peak0-3h FEV1 after 6 weeks of treatment. The 69% result is based upon the change from baseline.⁶
• ¶¶ Reduction in the use of rescue medication during daytime.¹⁷
• §§ The starting point for the y-axis is 1.20.
• *** p=0.0002 for comparisons of SPIOLTO® RESPIMAT® + SMBM and EXT v s placebo.¹⁸
• ††† An improvement of 4 or more points in SGRQ total score is considered clinically meaningful for the patient.¹⁵
• ### This post-hoc analysis of the WISDOM study tested whether or not combining blood eosinophil counts and exacerbation history could better identify patients who were more responsive to ICS.¹³
• ¶¶¶ The decision to use LAMA/LABA as initial treatment should be guided by the level of symptoms as an advantage of LAMA/LABA over LAMA for exacerbation prevention has not been consistently demonstrated.¹
• §§§ Consider LABA/ICS if eosinophils ≥300 cells/μL or in patients with a history of asthma.¹
• ‖‖ GOLD 2020 recommends LAMA/LABA as a first-line treatment option in symptomatic COPD patients with severe breathlessness regardless of exacerbation risk (consider if highly symptomatic e.g. CAT >20; the decision to sue LAMA/LABA as initial treatment should be guided by the level of symptoms as an advantage of LAMA/LABA over LAMA for exacerbation prevention has not been consistently demonstrated.¹ ATS 2020 recommends LAMA/ LABA over LAMA or LABA monotherapy in patients with COPD and dyspnoea or exercise intolerance.²
• ‖‖‖ ICS-containing therapies are not recommended for the majority of COPD patients as initial treatment, but can be considered if eosinophil count is ≥300 cells/μL.¹
• ‡‡‡ GOLD Group B: For patients with severe breathlessness initial therapy with two bronchodilators may be considered.¹

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