Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial

Lee, Laurie A.; Bailes, Zelie; Barnes, Neil; Boulet, Louis‐Philippe; Edwards, Dawn; Fowler, Andrew; Hanania, Nicola A.; Kerstjens, Huib A. M.; Kerwin, Edward; Nathan, Robert A.; Oppenheimer, John; Papi, Alberto; Pascoe, Steven; Brusselle, Guy; Peachey, Guy; Sule, Neal; Tabberer, Maggie; Pavord, Ian

doi:10.1016/s2213-2600(20)30389-1

Cited by 157 publications

(225 citation statements)

References 30 publications

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“…Other positive aspects related to the CAPTAIN study consist of the 5-week pre-randomisation period during which standardised medication was provided, and both comparators (FF/ VI and FF/UMEC/VI) were administered with the same dry powder inhaler. However, there is an important difference between the present study and its predecessors in terms of asthma exacerbations [1][2][3]. While the TRIGGER and TRIMARAN tiotropium studies showed reductions in severe exacerbations with the addition of LAMA, these effects were not observed with the addition of UMEC to FF/VI.…”

Section: Commentarycontrasting

confidence: 54%

Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial

Ojanguren

Pilia

2021

Breathe

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Triple therapy with FF/UMEC/VI improved lung function in patients with moderate or severe uncontrolled asthma on ICS/LABA but did not lead to a reduction in moderate and/or severe exacerbations https://bit.ly/38UnuRW Journal club Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial Cite as: Ojanguren I, Pilia MF. Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial.

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Section: Commentarycontrasting

confidence: 54%

Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial

Ojanguren

Pilia

2021

Breathe

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“…Adding umeclidinium to the combination of ICS/LABA was found to be effective treatment option with a favorable risk–benefit profile as it led to improved symptoms and FEV 1 but did not result in significant reduction in moderate and/or severe exacerbations. [ 155 ] Higher dose of fluticasone furoate (200 mcg) primarily reduced the rate of exacerbations, particularly in patients with raised biomarkers of type 2 airway inflammation Adding tiotropium to the combination of medium-dose ICS and LABA is another option as it significantly improves lung function in uncontrolled cases and modestly reduces asthma attacks (Evidence A)[ 156 157 158 ] Adding LTRA to the combination of medium-dose ICS and LABA can be considered, but the evidence is less robust (Evidence B)[ 159 160 161 ] Adding theophylline to the combination of medium-dose ICS and LABA is another less favorable alternative (Evidence B). [ 159 162 ] Other considerations High-dose ICS/LABA may be considered in some patients who are uncontrolled on medium-dose ICS/LABA.…”

Section: Section 6: Pharmacological Management In Adults and Adolescementioning

confidence: 99%

Section: Section 6: Pharmacological Management In Adults and Adolescementioning

confidence: 99%

“…In patients with uncontrolled moderate or severe asthma on a combination of ICS/LABA, adding umeclidinium was found to be an effective treatment option with favorable risk–benefit profile as it led to improved FEV 1 and asthma symptoms but did not result in significant reduction in moderate and/or severe exacerbations. [ 155 ] A higher dose of fluticasone furoate (200 mcg) primarily reduced the rate of exacerbations, particularly in patients with raised biomarkers of type 2 airway inflammation. Other triple therapy combinations are approved for COPD treatment but not yet for asthma, such as the combination of budesonide 320 mcg, glycopyrronium 14.6 mcg, and formoterol fumarate 9.6 mcg (Breztri Aerosphere ® ) and the combination of mometasone furoate 160 mcg, glycopyrronium bromide 63 mcg, and indacaterol 150 mcg (Enerzair Breezhaler ® ).…”

Section: Section 11: Appendix Of Medications Used In Asthma Treatmentmentioning

confidence: 99%

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The Saudi Initiative for Asthma - 2021 Update: Guidelines for the diagnosis and management of asthma in adults and children

et al. 2021

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The Saudi Initiative for Asthma 2021 (SINA-2021) is the fifth version of asthma guidelines for the diagnosis and management of asthma for adults and children, which is developed by the SINA group, a subsidiary of the Saudi Thoracic Society. The main objective of the SINA is to have guidelines that are up to date, simple to understand, and easy to use by healthcare workers dealing with asthma patients. To facilitate achieving the goals of asthma management, the SINA panel approach is mainly based on the assessment of symptom control and risk for both adults and children. The approach to asthma management is aligned for age groups: adults, adolescents, children aged 5–12 years, and children aged less than 5 years. SINA guidelines have focused more on personalized approaches reflecting better understanding of disease heterogeneity with the integration of recommendations related to biologic agents, evidence-based updates on treatment, and the role of immunotherapy in management. Medication appendix has also been updated with the addition of recent evidence, new indications for existing medication, and new medications. The guidelines are constructed based on the available evidence, local literature, and the current situation at national and regional levels. There is also an emphasis on patient–doctor partnership in the management that also includes a self-management plan.

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“…published, showing that different ICS/LABA/LAMA combinations can improve lung function and symptoms in patients with moderate or severe asthma who remain uncontrolled with ICS/LABA. [68][69][70] High ICS doses would be only prescribed in "T2-high" patients who have failed prior therapeutic attempts. Consequently, biologic therapy would be restricted to those asthmatics who remain uncontrolled with high-dose ICS triple therapy if they express biomarkers indicative of "T2-high" inflammatory response.…”

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confidence: 99%

Phenotype-Guided Asthma Therapy: An Alternative Approach to Guidelines

Llano

Rivas

Cid

et al. 2021

JAA

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Despite recent advances in therapy, a substantial proportion of asthmatics remain not well controlled. The classical stepwise approach to pharmacological therapy in adult asthma recommends that treatment is progressively stepped up by increasing the inhaled corticosteroid (ICS) dose or by adding another controller medication-to achieve symptom control and reduce the risk of exacerbations, and stepped down after a period of control. In general, asthma guideline recommendations do not reflect that there are significant differences between ICS in terms of potency. Moreover, they do not consider efficacy and safety separately, incorrectly assuming that "low" and "high" dose categories inevitably correspond with low and high risk of systemic effects. Another point of criticism is the fact that guidelines do not take into account the inflammatory profile of the patient, although substantial groups of patients with mild and moderate asthma have little evidence of "T2high" inflammation, and by extension are likely to show a poor response to ICS treatment. On the other hand, the latest version of the Global Initiative for Asthma (GINA) equally recommends regular ICS and ICS/formoterol as needed to prevent exacerbations in step 2 patients, without taking into consideration that the therapeutic objectives (exacerbations, symptoms) may differ between individual patients and that different goals may warrant distinct treatment strategies. In this review, we bring to the table several controversial issues concerning asthma treatment and suggest an alternative proposal that takes into consideration the potential side effects of high ICS doses, the patient's inflammatory profile and the therapeutic goals to be achieved.

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Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial

Cited by 157 publications

References 30 publications

Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial

Efficacy and safety of once-daily single-inhaler triple therapy in patients with inadequately controlled asthma: the CAPTAIN trial

The Saudi Initiative for Asthma - 2021 Update: Guidelines for the diagnosis and management of asthma in adults and children

Phenotype-Guided Asthma Therapy: An Alternative Approach to Guidelines

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