FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease

Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β -agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited. We compared the effects of once-daily triple therapy on lung function and health-related quality of life wi...

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Vydáno v:	American journal of respiratory and critical care medicine Ročník 196; číslo 4; s. 438 - 446
Hlavní autoři:	Lipson, David A., Barnacle, Helen, Birk, Ruby, Brealey, Noushin, Locantore, Nicholas, Lomas, David A., Ludwig-Sengpiel, Andrea, Mohindra, Rajat, Tabberer, Maggie, Zhu, Chang-Qing, Pascoe, Steven J.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States American Thoracic Society 15.08.2017
Témata:	Administration, Inhalation Androstadienes - therapeutic use Benzyl Alcohols - therapeutic use Bronchodilator Agents - therapeutic use Budesonide - therapeutic use Chlorobenzenes - therapeutic use Chronic obstructive pulmonary disease Clinical medicine Clinical trials Double-Blind Method Drug Administration Schedule Drug dosages Drug Therapy, Combination Female Forced Expiratory Volume - drug effects Formoterol Fumarate - therapeutic use Health risk assessment Humans Lung diseases Male Middle Aged Nebulizers and Vaporizers Patients Pulmonary Disease, Chronic Obstructive - drug therapy Quality of Life Quinuclidines - therapeutic use health-related quality of life lung function single-inhaler triple therapy chronic obstructive pulmonary disease
ISSN:	1073-449X, 1535-4970, 1535-4970
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Abstract	Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β -agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited. We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy in patients with COPD. The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). A patient subgroup remained on blinded treatment for up to 52 weeks. Co-primary endpoints were change from baseline in trough FEV and in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24. In the intent-to-treat population (n = 1,810) at Week 24 for triple therapy (n = 911) and ICS/LABA therapy (n = 899), mean changes from baseline in FEV were 142 ml (95% confidence interval [CI], 126 to 158) and -29 ml (95% CI, -46 to -13), respectively, and mean changes from baseline in SGRQ scores were -6.6 units (95% CI, -7.4 to -5.7) and -4.3 units (95% CI, -5.2 to -3.4), respectively. For both endpoints, the between-group differences were statistically significant (P < 0.001). There was a statistically significant reduction in moderate/severe exacerbation rate with triple therapy versus dual ICS/LABA therapy (35% reduction; 95% CI, 14-51; P = 0.002). The safety profile of triple therapy reflected the known profiles of the components. These results support the benefits of single-inhaler triple therapy compared with ICS/LABA therapy in patients with advanced COPD. Clinical trial registered with www.clinicaltrials.gov (NCT02345161).
AbstractList	Methods: The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 mg/62.5 mg/25 mg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 mg/12 mg; Turbuhaler). Medical writing support in the form of development of the draft outline and manuscript drafts in consultation with the authors, editorial suggestions for draft versions of this paper, assembling tables and figures, collating author comments, copyediting, referencing, and graphic services was provided by Alison Scott, Ph.D., of Gardiner-Caldwell Communications, Macclesfield, United Kingdom, and was funded by GSK. E-mail: david.a.lipson@gsk.com This article has an online supplement, which is accessible from this issue's table of contents at www.atsjournals.org Am J Respir Crit Care Med Vol 196, Iss 4, pp 438-446, Aug 15, 2017 Copyright © 2017 by the American Thoracic Society Originally Published in Press as DOI: 10.1164/rccm.201703-0449OC on April 4, 2017 Internet address: www.atsjournals.org At a Glance Commentary Scientific Knowledge on the Subject: Although inhaled triple pharmacologic therapy is recommended for patients with advanced chronic obstructive pulmonary disease and is often used clinically as step-up treatment, few randomized controlled trials have assessed the benefit of triple therapy compared with dual inhaled corticosteroid/long-acting ß2-agonist therapy. What This Study Adds to the Field: Results from the FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) study demonstrated the clinical benefit of once-daily fluticasone furoate/umeclidinium/ vilanterol combination therapy using a single inhaler compared with twice-daily budesonide/formoterol combination therapy. Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited.RATIONALERandomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited.We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy in patients with COPD.OBJECTIVESWe compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy in patients with COPD.The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). A patient subgroup remained on blinded treatment for up to 52 weeks. Co-primary endpoints were change from baseline in trough FEV1 and in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24.METHODSThe FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). A patient subgroup remained on blinded treatment for up to 52 weeks. Co-primary endpoints were change from baseline in trough FEV1 and in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24.In the intent-to-treat population (n = 1,810) at Week 24 for triple therapy (n = 911) and ICS/LABA therapy (n = 899), mean changes from baseline in FEV1 were 142 ml (95% confidence interval [CI], 126 to 158) and -29 ml (95% CI, -46 to -13), respectively, and mean changes from baseline in SGRQ scores were -6.6 units (95% CI, -7.4 to -5.7) and -4.3 units (95% CI, -5.2 to -3.4), respectively. For both endpoints, the between-group differences were statistically significant (P < 0.001). There was a statistically significant reduction in moderate/severe exacerbation rate with triple therapy versus dual ICS/LABA therapy (35% reduction; 95% CI, 14-51; P = 0.002). The safety profile of triple therapy reflected the known profiles of the components.MEASUREMENTS AND MAIN RESULTSIn the intent-to-treat population (n = 1,810) at Week 24 for triple therapy (n = 911) and ICS/LABA therapy (n = 899), mean changes from baseline in FEV1 were 142 ml (95% confidence interval [CI], 126 to 158) and -29 ml (95% CI, -46 to -13), respectively, and mean changes from baseline in SGRQ scores were -6.6 units (95% CI, -7.4 to -5.7) and -4.3 units (95% CI, -5.2 to -3.4), respectively. For both endpoints, the between-group differences were statistically significant (P < 0.001). There was a statistically significant reduction in moderate/severe exacerbation rate with triple therapy versus dual ICS/LABA therapy (35% reduction; 95% CI, 14-51; P = 0.002). The safety profile of triple therapy reflected the known profiles of the components.These results support the benefits of single-inhaler triple therapy compared with ICS/LABA therapy in patients with advanced COPD. Clinical trial registered with www.clinicaltrials.gov (NCT02345161).CONCLUSIONSThese results support the benefits of single-inhaler triple therapy compared with ICS/LABA therapy in patients with advanced COPD. Clinical trial registered with www.clinicaltrials.gov (NCT02345161). Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β -agonist (LABA) therapy in patients with chronic obstructive pulmonary disease (COPD) are limited. We compared the effects of once-daily triple therapy on lung function and health-related quality of life with twice-daily ICS/LABA therapy in patients with COPD. The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticasone furoate/umeclidinium/vilanterol 100 μg/62.5 μg/25 μg; ELLIPTA inhaler) with twice-daily ICS/LABA therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). A patient subgroup remained on blinded treatment for up to 52 weeks. Co-primary endpoints were change from baseline in trough FEV and in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24. In the intent-to-treat population (n = 1,810) at Week 24 for triple therapy (n = 911) and ICS/LABA therapy (n = 899), mean changes from baseline in FEV were 142 ml (95% confidence interval [CI], 126 to 158) and -29 ml (95% CI, -46 to -13), respectively, and mean changes from baseline in SGRQ scores were -6.6 units (95% CI, -7.4 to -5.7) and -4.3 units (95% CI, -5.2 to -3.4), respectively. For both endpoints, the between-group differences were statistically significant (P < 0.001). There was a statistically significant reduction in moderate/severe exacerbation rate with triple therapy versus dual ICS/LABA therapy (35% reduction; 95% CI, 14-51; P = 0.002). The safety profile of triple therapy reflected the known profiles of the components. These results support the benefits of single-inhaler triple therapy compared with ICS/LABA therapy in patients with advanced COPD. Clinical trial registered with www.clinicaltrials.gov (NCT02345161).
Author	Pascoe, Steven J. Zhu, Chang-Qing Locantore, Nicholas Tabberer, Maggie Lomas, David A. Lipson, David A. Ludwig-Sengpiel, Andrea Mohindra, Rajat Barnacle, Helen Birk, Ruby Brealey, Noushin
Author_xml	– sequence: 1 givenname: David A. surname: Lipson fullname: Lipson, David A. organization: GlaxoSmithKline, King of Prussia, Pennsylvania, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania – sequence: 2 givenname: Helen surname: Barnacle fullname: Barnacle, Helen organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 3 givenname: Ruby surname: Birk fullname: Birk, Ruby organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 4 givenname: Noushin surname: Brealey fullname: Brealey, Noushin organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 5 givenname: Nicholas surname: Locantore fullname: Locantore, Nicholas organization: GlaxoSmithKline, King of Prussia, Pennsylvania – sequence: 6 givenname: David A. surname: Lomas fullname: Lomas, David A. organization: UCL Respiratory, University College London, London, United Kingdom; and – sequence: 7 givenname: Andrea surname: Ludwig-Sengpiel fullname: Ludwig-Sengpiel, Andrea organization: KLB Health Research, Lübeck, Germany – sequence: 8 givenname: Rajat surname: Mohindra fullname: Mohindra, Rajat organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 9 givenname: Maggie surname: Tabberer fullname: Tabberer, Maggie organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 10 givenname: Chang-Qing surname: Zhu fullname: Zhu, Chang-Qing organization: GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom – sequence: 11 givenname: Steven J. surname: Pascoe fullname: Pascoe, Steven J. organization: GlaxoSmithKline, King of Prussia, Pennsylvania
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/28375647$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Copyright	Copyright American Thoracic Society Aug 15, 2017
Copyright_xml	– notice: Copyright American Thoracic Society Aug 15, 2017
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DOI	10.1164/rccm.201703-0449OC
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References	bib14 bib15 bib12 bib13 bib10 bib21 bib11 bib20 bib9 bib7 bib8 bib18 bib6 bib19 bib16 bib4 bib17 bib1 bib2 Lomas D (bib5) 2016; 48 29241016 - Am J Respir Crit Care Med. 2018 May 1;197(9):1230-1231. doi: 10.1164/rccm.201711-2313LE. 28950068 - Am J Respir Crit Care Med. 2018 Feb 15;197(4):542-543. doi: 10.1164/rccm.201709-1831LE. 28950066 - Am J Respir Crit Care Med. 2018 Feb 15;197(4):542. doi: 10.1164/rccm.201708-1578LE. 28534641 - Am J Respir Crit Care Med. 2017 Oct 15;196(8):1082-1083. doi: 10.1164/rccm.201704-0811LE. 29241021 - Am J Respir Crit Care Med. 2018 May 1;197(9):1229-1230. doi: 10.1164/rccm.201710-2092LE. 28534669 - Am J Respir Crit Care Med. 2017 Oct 15;196(8):1083-1084. doi: 10.1164/rccm.201704-0818LE. 28534640 - Am J Respir Crit Care Med. 2017 Oct 15;196(8):1082. doi: 10.1164/rccm.201704-0728LE. 28809512 - Am J Respir Crit Care Med. 2017 Aug 15;196(4):402-404. doi: 10.1164/rccm.201704-0760ED.
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Snippet	Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β -agonist (LABA) therapy in patients with chronic obstructive... Methods: The FULFIL (Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy) trial was a randomized,... Randomized data comparing triple therapy with dual inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with chronic obstructive...
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SubjectTerms	Administration, Inhalation Androstadienes - therapeutic use Benzyl Alcohols - therapeutic use Bronchodilator Agents - therapeutic use Budesonide - therapeutic use Chlorobenzenes - therapeutic use Chronic obstructive pulmonary disease Clinical medicine Clinical trials Double-Blind Method Drug Administration Schedule Drug dosages Drug Therapy, Combination Female Forced Expiratory Volume - drug effects Formoterol Fumarate - therapeutic use Health risk assessment Humans Lung diseases Male Middle Aged Nebulizers and Vaporizers Patients Pulmonary Disease, Chronic Obstructive - drug therapy Quality of Life Quinuclidines - therapeutic use
Title	FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease
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