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International Journal of Chronic Obstructive Pulmonary Disease Volume 16, 2021 - Issue
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Original Research

Treatment of COPD with Long-Acting Bronchodilators: Association Between Early and Longer-Term Clinically Important Improvement

Claus F Vogelmeier1 Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence[email protected]
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,
Ian P Naya2 Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK;3 RAMAX Ltd, Bramhall, Cheshire, UKView further author information
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François Maltais4 Centre De Pneumologie, Institut Universitaire De Cardiologie Et De Pneumologie De Québec, Université Laval, Québec, CanadaORCID Iconhttps://orcid.org/0000-0002-6809-4651View further author information
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Leif Bjermer5 Respiratory Medicine and Allergology, Lund University, Lund, SwedenORCID Iconhttps://orcid.org/0000-0002-3441-8099View further author information
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Edward M Kerwin6 Altitude Clinical Consulting and Clinical Research Institute of Southern Oregon, Medford, OR, USAORCID Iconhttps://orcid.org/0000-0002-1697-9036View further author information
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Lee Tombs7 Precise Approach Ltd, Contingent Worker on Assignment at GSK, Brentford, Middlesex, UKView further author information
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Paul W Jones2 Global Specialty & Primary Care, GSK, Brentford, Middlesex, UKORCID Iconhttps://orcid.org/0000-0001-6087-9182View further author information
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Chris Compton2 Global Specialty & Primary Care, GSK, Brentford, Middlesex, UKView further author information
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David A Lipson8 Respiratory Clinical Sciences, GSK, Collegeville, PA, USA;9 Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USAORCID Iconhttps://orcid.org/0000-0001-6732-4593View further author information
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Isabelle H Boucot2 Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK;10 Medical Emerging Markets, GSK, Brentford, Middlesex, UKORCID Iconhttps://orcid.org/0000-0003-0410-4969View further author information
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Pages 1215-1226 | Published online: 03 May 2021

Figures & data

Table 1 Patient Demographics and Baseline Characteristics

Table 2 Association Between Patient Demographics and Baseline Characteristics and the Achievement of a CII at Week 4

Figure 1 Proportion of patients achieving a CII at Weeks 12 and 24 stratified by the achievement of a CII at Week 4.

Abbreviations: CI, confidence interval; CII, clinically important improvement; OR, odds ratio.
Figure 1 Proportion of patients achieving a CII at Weeks 12 and 24 stratified by the achievement of a CII at Week 4.

Table 3 Ordered OR of GADS Improvement on the 7-Point Likert Scale at Week 4

Table 4 Combinations of PRO Responses at Week 4 by Treatment

Figure 2 Proportion of patients with a Clinically Important Deterioration (CID)a after Day 30 by: (A) achievement of a CII at Week 4; (B) the number of PRO responses at Week 4; (C) Kaplan–Meier curve of time to first CID in patients by achievement of CII at Week 4.

Notes: aA CID was defined as a first moderate or severe exacerbation, and/or a SGRQ deterioration (≥4 units from baseline), and/or a CAT deterioration (≥2 units from baseline), and/or a SAC-TDI deterioration (≥1 unit decrease from baseline).
Abbreviations: CAT, COPD Assessment Test; CID, clinically important deterioration; CI, confidence interval; CII, clinically important improvement; COPD, chronic obstructive pulmonary disease; HR, hazard ratio; PRO, patient-reported outcome; SAC-TDI, self-administered computerized-Transition Dyspnea Index; SGRQ, St George’s Respiratory Questionnaire.
Figure 2 Proportion of patients with a Clinically Important Deterioration (CID)a after Day 30 by: (A) achievement of a CII at Week 4; (B) the number of PRO responses at Week 4; (C) Kaplan–Meier curve of time to first CID in patients by achievement of CII at Week 4.

Table 5 Proportion of Patients Who Maintained Their Week 4 CII Status at Week 24

Figure 3 Proportion of patients achieving CII (reaching MCID in at least two PROs) at Weeks 4, 12 and 24a.

Notes: aAnalysis of patients with a responder status for ≥2 PROs at each visit.
Abbreviations: CI, confidence interval; CII, clinically important improvement; MCID, minimum clinically important difference; OR, odds radio; PRO, patient-reported outcome; SAL, salmeterol; UMEC, umeclidinium; VI, vilanterol.
Figure 3 Proportion of patients achieving CII (reaching MCID in at least two PROs) at Weeks 4, 12 and 24a.

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