Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial

Devillier, Philippe; Humbert, Marc; Boye, Alain; Zachgo, Wolfgang; Jacques, Loretta; Nunn, Carol; West, Sarah; Nicholls, Andrew; Antoun, Zeina; Spinu, L.; Grouin, Jean‐Marie

doi:10.1016/j.rmed.2018.06.009

Cited by 12 publications

(4 citation statements)

References 26 publications

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“…Published data about indacaterol ( 4 ) and olodaterol ( 5 ) only provide the evidence that they maintain effective relaxation for over 24 h in asthma, and there is no specific dose and dose frequency for olodaterol ( 5 ) or its combination with ICS . Recent studies have shown that the new combination mometasone furoate/indacaterol acetate, also known as QMF149, may be a potential therapeutic option for asthma. , In addition, the efficacy of fluticasone furoate/vilanterol ( 6 ) in asthma has also being evaluated. , The once-daily dosing regimen associated with the use of these agents is an advantage over the traditional ICS/LABA combination therapy as adherence is enhanced.…”

Section: β2-agonistsmentioning

confidence: 99%

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Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Xing

Woo

et al. 2020

J. Med. Chem.

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β 2 -Adrenoceptor (β 2 -AR) agonists are widely used as bronchodilators. The emerge of ultralong acting β 2 -agonists is an important breakthrough in pulmonary medicine. In this review, we will provide mechanistic insights into the application of β 2agonists in asthma, chronic obstructive pulmonary disease (COPD), and heart failure (HF). Recent studies in β-AR signal transduction have revealed opposing functions of the β 1 -AR and the β 2 -AR on cardiomyocyte survival. Thus, β 2 -agonists and βblockers in combination may represent a novel strategy for HF management. Allosteric modulation and biased agonism at the β 2 -AR also provide a theoretical basis for developing drugs with novel mechanisms of action and pharmacological profiles. Overlap of COPD and HF presents a substantial clinical challenge but also a unique opportunity for evaluation of the cardiovascular safety of β 2 -agonists. Further basic and clinical research along these lines can help us develop better drugs and innovative strategies for the management of these difficult-to-treat diseases.

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Section: β2-agonistsmentioning

confidence: 99%

“…234,235 In addition, the efficacy of fluticasone furoate/ vilanterol (6) in asthma has also being evaluated. 236,237 The once-daily dosing regimen associated with the use of these agents is an advantage over the traditional ICS/LABA combination therapy as adherence is enhanced.…”

Section: Mechanisms Of Actionmentioning

confidence: 99%

Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Xing

Woo

et al. 2020

J. Med. Chem.

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“…12 Safety results of dual combination therapy with FF/VI have also shown a favorable risk profile, with headache, nervous system disorders, and nasopharyngitis reported as the most frequently occurring on-treatment AEs. 4,13 Treatment with umeclidinium (UMEC), a LAMA, was also not associated with significant safety concerns; the most frequently reported on-treatment AEs included headache, nasopharyngitis, abnormal product taste, and pharyngitis. 14,15 Single-inhaler triple therapy with the combination of FF/UMEC/VI is widely approved as a once-daily treatment for chronic obstructive pulmonary disease (COPD).…”

Section: Introductionmentioning

confidence: 99%

Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study

Hozawa¹,

Ohbayashi²,

Tsuchiya

et al. 2021

JAA

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The pivotal CAPTAIN study reported a favorable safety profile with once-daily inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist (ICS/LAMA/LABA) triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with inadequately controlled asthma, some of whom were Japanese. Here, we evaluate the long-term (52 weeks) safety of FF/UMEC/VI in Japanese patients with asthma. Patients and Methods: This was a Phase III, 52-week, multicenter, non-comparator, non-randomized, open-label study (NCT03184987) in Japanese adults receiving maintenance therapy with ICS/LABA, with or without LAMA. At enrollment, patients were allocated to either FF/UMEC/VI 100/62.5/25mcg (Group 1) or 200/62.5/25mcg (Group 2). Patients in Group 1 could have their treatment stepped up to 200/62.5/25mcg at Week 24 if their Asthma Control Questionnaire (ACQ)-7 score was >0.75. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Secondary endpoints included vital signs, electrocardiogram measurements, and clinical laboratory tests (biochemistry, hematology, urinalysis). Efficacy was assessed as "other" endpoints. Results: A total of 111 Japanese patients were included in the intention-to-treat (ITT) population. Overall, 77 (69%) patients reported ≥1 AE (Group 1: n=30 [64%]; step-up group: n=7 [78%]; Group 2: n=40 [73%]). SAEs were reported for 1 (2.1%) and 2 (3.6%) patients in Groups 1 and 2, respectively. All SAEs were considered unrelated to study treatment. One AE and one SAE led to study withdrawal: oropharyngeal discomfort (Group 1); eosinophilic granulomatosis with polyangiitis (Group 2). No new safety concerns were identified throughout the 52-week treatment period. Conclusion:In this uncontrolled open-label study, no new safety concerns were observed with long-term (52 weeks) treatment with once-daily FF/UMEC/VI among 111 Japanese patients with asthma.

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“…These randomized control studies have compared the effects of FF/VI DPI combination versus placebo or fluticasone propionate/salmeterol (FP/SLM) DPI on acute exacerbations, pulmonary function, health-related quality of life, and adverse effects, in patients with chronic asthma. In addition, there have been some reports to compare FF/VI DPI therapy with other ICS/LABA combinations, such as budesonide/formoterol (BUD/FM) DPI, and assess patient adherence in asthma inhaler treatment recently 15,16. Therefore, we conducted this randomized crossover study to compare the clinical effects and inhalation adherence barriers of once-daily FF/VI DPI versus twice-daily BUD/FM DPI in patients with controlled stable asthma on ICS/LABA treatment.…”

Section: Introductionmentioning

confidence: 99%

<p>Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial</p>

Furuhashi

Fujisawa

Dai

et al. 2019

JAA

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IntroductionFluticasone furoate (FF)/vilanterol (VI) dry powder inhaler (DPI) is the only once-daily maintenance inhaled corticosteroid (ICS)/long-acting β2 adrenergic agonist (LABA) combination for asthma. We aimed to compare the clinical effects of once-daily FF/VI and twice-daily budesonide (BUD)/formoterol (FM) DPI in patients with controlled stable asthma.MethodsWe performed a randomized crossover trial in which stable asthmatic patients controlled on ICS/LABA received 8 weeks of FF/VI (100/25 μg 1 puff once-daily) or BUD/FM (160/4.5 μg 2 puffs twice-daily) DPI treatment. After a 4–8-week washout period, patients received another crossover treatment for 8 weeks. We assessed pulmonary function, the 5-item version asthma control questionnaire (ACQ5), the asthma control test (ACT), and fractional exhaled nitric oxide (FeNO) at baseline and after 8 weeks of treatment (week 8). As the primary outcome was change in force expiratory volume in 1 s (FEV1) between baseline and week 8, we evaluated the incidence of asthma exacerbation and adherence barrier questionnaire (Ask-12) at week 8.ResultsTwenty-three patients were initially enrolled in this study; however, one patient had to be excluded. The FF/VI DPI treatment group showed a similar magnitude of change in FEV1 between baseline and week 8 as the BUD/FM DPI treatment group. In addition, there were no significant differences in pulmonary function tests, ACQ5 scores, ACT scores, and FeNO between baseline and week 8 in both groups. Although the incidence of exacerbation did not differ between groups, the Ask-12 score in the FF/VI DPI group was significantly lower than that in the BUD/FM DPI group.ConclusionsThe present study indicates that once-daily FF/VI DPI is not inferior to twice-daily BUD/FM DPI in clinical effect and more likely to improve inconvenience and forgetfulness in inhalation adherence barriers for stable asthma control therapy. Once-daily FF/VI DPI may be an effective alternative for asthma maintenance treatment.

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Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial

Abstract: These findings suggest that, in a tightly controlled randomized controlled trial setting, once-daily FF/VI provides similar asthma control over 24 weeks to usual, twice-daily ICS/LABA in patients with asthma that is uncontrolled on ICS alone. FF/VI was well tolerated.

Cited by 12 publications

References 26 publications

Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study

<p>Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial</p>

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Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial

Abstract: These findings suggest that, in a tightly controlled randomized controlled trial setting, once-daily FF/VI provides similar asthma control over 24 weeks to usual, twice-daily ICS/LABA in patients with asthma that is uncontrolled on ICS alone. FF/VI was well tolerated.

Cited by 12 publications

References 26 publications

Recent Advances in β2-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Recent Advances in β2-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study

<p>Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial</p>

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Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure

Recent Advances in β₂-Agonists for Treatment of Chronic Respiratory Diseases and Heart Failure