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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Shrnutí: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).
Bibliografie:ObjectType-Article-1
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ISSN:1073-449X
1535-4970
1535-4970
DOI:10.1164/rccm.201703-0449OC