Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial

Papi, Alberto; Vestbo, Jørgen; Fabbri, Leonardo M.; Corradi, Massimo; Prunier, H; Cohuet, Géraldine; Guasconi, Alessandro; Montagna, Isabella; Vezzoli, Stefano; Petruzzelli, Stefano; Scuri, Mario; Roche, Nicolás; Singh, Dave

doi:10.1016/s0140-6736(18)30206-x

Cited by 501 publications

(556 citation statements)

References 22 publications

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“…A comprehensive electronic database search provided 1,139 studies for review, and manual search identified 39 additional studies. After review, 12 RCTs comparing triple inhaler therapy with dual inhaler therapy in patients with moderate‐to‐severe COPD remained and were included in the analysis . We have excluded trials that evaluated the de‐escalation of triple therapy to dual therapy as patients in both treatment arms received triple inhaler before de‐escalation to dual therapy which could affect the results .…”

Section: Resultsmentioning

confidence: 99%

Triple versus dual inhaler therapy in moderate‐to‐severe COPD: A systematic review and meta‐analysis of randomized controlled trials

Zayed

Barbarawi

Kheiri

et al. 2019

Clinical Respiratory J

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Introduction Treatment of chronic obstructive pulmonary disease (COPD) is evolving specially with triple inhaler therapy. Objectives To perform a meta‐analysis to ascertain the safety and efficacy of triple inhaler therapy consisting of an inhaled‐glucocorticoid (ICS), long‐acting muscarinic antagonist (LAMA) and long‐acting beta2‐agonist (LABA) when compared with dual therapy (ICS‐LABA or LAMA‐LABA). Methods We performed an electronic database search to include randomized controlled trials (RCTs) comparing between triple and dual inhalers. Pooled rate‐ratio (RR) or odds‐ratio (OR) for dichotomous data and weighted mean difference (MD) for continuous data were calculated with their corresponding 95% confidence interval (CI). Results Our study included 12 RCTs totaling 19,322 patients, mean age of 65 ± 8.2 years and 68.2% were male. Pooled analysis demonstrated a significant reduction in moderate‐to‐severe COPD exacerbations with triple therapy (RR 0.75; 95% CI 0.69‐0.83; P < 0.01). Additionally, triple therapy caused significant increase in trough FEV1 (MD 0.09 L; 95% CI 0.07‐0.12; P < 0.01), significant reduction in the mean St. George's Respiratory Questionnaire (SGRQ) score (MD −1.67; 95% CI −2.02‐ −1.31; P < 0.01), and more patients experienced ≥ 4 points reduction of SGRQ score (OR 1.27; 95% CI 1.19‐1.35; P < 0.01). Triple therapy was associated with an increased risk of pneumonia when compared to LABA/LAMA (OR 1.25; 95% 1.03‐1.97; P = 0.03) but there were no significant differences in other adverse events between triple and dual inhalers. Conclusions Among patients with moderate‐to‐severe COPD, triple inhaler therapy was associated with a reduction of moderate‐to‐severe COPD exacerbations, improved lung function and improved quality of life when compared to dual inhaler therapy but with an increased pneumonia risk.

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Section: Resultsmentioning

confidence: 99%

Triple versus dual inhaler therapy in moderate‐to‐severe COPD: A systematic review and meta‐analysis of randomized controlled trials

Zayed

Barbarawi

Kheiri

et al. 2019

Clinical Respiratory J

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“…In der randomisierten Doppelblindstudie TRIBUTE wurde die Wirksamkeit der extra feinen Dreifach-Fixkombination (GB/ FF/ BDP) mit der LAMA/LABA-Kombination aus GB/Indacaterol (IND) hinsichtlich der Reduktion moderater bis schwerer Exazerbationen bei COPD verglichen [1]. Bei vergleichbarem Sicherheitsprofil erreichte GB/FF/BDP den primären Studienendpunkt mit einer signifikanten Reduktion der Rate moderater bis schwerer Exazerbationen um 15,2% im Vergleich zu GB/IND (p = 0,043) [1].…”

Section: Tribute -Extrafeine Dreifach-fixkombination üBerlegenunclassified

“…Bei vergleichbarem Sicherheitsprofil erreichte GB/FF/BDP den primären Studienendpunkt mit einer signifikanten Reduktion der Rate moderater bis schwerer Exazerbationen um 15,2% im Vergleich zu GB/IND (p = 0,043) [1]. Eine Überlegenheit zeigte sich auch in der Subgruppe der GOLD-B-Patienten: Hier konnte die Dreifachtherapie moderate bis schwere Exazerbationen um 23% reduzieren [8].…”

Section: Tribute -Extrafeine Dreifach-fixkombination üBerlegenunclassified

PharmaNews

2019

Kompass Pneumol

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“…The incidence of pneumonia was, however, significantly increased in patients receiving an ICS [70]. Therefore, triple therapy should be considered in selected, symptomatic patients with severe airflow obstruction and at least one exacerbation in the previous year [71].…”

Section: Triple Inhaled Therapymentioning

confidence: 99%

Diagnosis, Prevention and Treatment of Stable COPD and Acute Exacerbations of COPD: The Swiss Recommendations 2018

et al. 2018

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The Swiss National Guidelines 2013 for chronic obstructive pulmonary disease have been revised in order to acknowledge recent progress in diagnosis and management of this disease. The resulting new Swiss recommendations are based on best evidence from the literature, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 report and other published national guidelines. Misdiagnosis of chronic obstructive pulmonary disease is common and means that patients do not always receive optimal treatment. To improve the management of patients with chronic obstructive pulmonary disease in Switzerland, these recommendations encourage a more comprehensive assessment of patients, based on the combined assessment of symptoms, degree of airflow limitation, risk of exacerbation and the presence of comorbidities. Recommendations for evidence-based preventive measures, as well as pharmacological and non-pharmacological strategies for the management of both stable and acute exacerbations of chronic obstructive pulmonary disease are provided in this update.

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Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial

Abstract: Chiesi Farmaceutici.

Cited by 501 publications

References 22 publications

Triple versus dual inhaler therapy in moderate‐to‐severe COPD: A systematic review and meta‐analysis of randomized controlled trials

Triple versus dual inhaler therapy in moderate‐to‐severe COPD: A systematic review and meta‐analysis of randomized controlled trials

PharmaNews

Diagnosis, Prevention and Treatment of Stable COPD and Acute Exacerbations of COPD: The Swiss Recommendations 2018

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