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International Journal of Chronic Obstructive Pulmonary Disease Volume 11, 2016 - Issue
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Original Research

Prevention of clinically important deteriorations in COPD with umeclidinium/vilanterol

Dave Singh1 Medicines Evaluation Unit, University of Manchester, University Hospital of South Manchester NHS Foundation Trust, Manchester, UKCorrespondence[email protected]
,
M Reza Maleki-Yazdi2 Division of Respiratory Medicine, Women’s College Hospital, University of Toronto, ON, Canada
,
Lee Tombs3 Precise Approach LTD, London UK
,
Ahmar Iqbal4 Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA
,
William A Fahy5 Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK
&
Ian Naya5 Respiratory Medicines Development Centre, GSK, Stockley Park, Middlesex, UK
Pages 1413-1424 | Published online: 24 Jun 2016

Figures & data

Table 1 Summary of patient demographics and baseline characteristics (ITT population)

Table 2 Summary and analysis of first and sustained CID in study A

Figure 1 Proportion of patients with a first and sustained CID (ITT population).

Notes: A moderate-to-severe exacerbation is defined as an acute worsening of COPD symptoms requiring the use of additional treatment including oral corticosteroids, antibiotics, emergency department treatment, or hospitalization.

Abbreviations: CID, clinically important deterioration; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; SGRQ, St George’s Respiratory Questionnaire; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Figure 1 Proportion of patients with a first and sustained CID (ITT population).Notes: A moderate-to-severe exacerbation is defined as an acute worsening of COPD symptoms requiring the use of additional treatment including oral corticosteroids, antibiotics, emergency department treatment, or hospitalization.Abbreviations: CID, clinically important deterioration; FEV1, forced expiratory volume in 1 second; ITT, intent-to-treat; SGRQ, St George’s Respiratory Questionnaire; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Figure 2 Time to first and sustained CID (ITT population).

Notes: P-values represent comparisons between placebo and UMEC/VI, or UMEC or VI (Study A), or UMEC/VI and TIO (Study B).
Abbreviations: CID, clinically important deterioration; ITT, intent-to-treat; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.
Figure 2 Time to first and sustained CID (ITT population).

Table 3 Summary and analysis of first and sustained CID in Study B (ITT population)

Table S1 Summary of trough FEV1 at day 169 and SGRQ total score at day 168 in Study A (ITT population)

Table S2 Summary of trough FEV1 at day 169 and SGRQ total score at day 168 in Study B (ITT population)

Table S3 Summary of first and sustained composite CID by subgroup in Study A (ITT population)

Table S4 Summary of first and sustained composite CID by subgroup in Study B (ITT population)

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