Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma

O’Byrne, Paul M.; Jacques, Loretta; Goldfrad, Caroline; Kwon, Namhee; Perrio, Michael J.; Yates, Louisa; Busse, William W.

doi:10.1186/s12931-016-0473-x

Cited by 10 publications

(7 citation statements)

References 29 publications

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“…and controlled ileal release formulated corticosteroids (including budesonide 6.0 mg q.d.) and is expected to increase with duration of exposure 21,23,30–34 . Adrenal AEs were reported during our studies in 14.4% of participants receiving BOS 2.0 mg b.i.d., most of which did not result in discontinuation of the study drug or in clinical manifestations of adrenal insufficiency or glucocorticoid excess.…”

Section: Discussionmentioning

confidence: 56%

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials

Hirano

Dellon

Gupta

et al. 2023

Aliment Pharmacol Ther

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Background: Questions remain regarding the safety of swallowed topical corticosteroids in eosinophilic oesophagitis (EoE). Aim:To assess the safety of an investigational formulation of budesonide (budesonide oral suspension; BOS) from six trials. Methods: Safety data were integrated from six trials (healthy adults: SHP621-101 [phase 1]; patients with EoE: MPI 101-01 and MPI 101-06 [phase 2]; SHP621-301, SHP621-302 and SHP621-303 [phase 3]) for participants who received ≥1 dose of study drug (BOS 2.0 mg twice daily [b.i.d.], BOS any dose [including BOS 2.0 mg b.i.d.] and placebo). Adverse events (AEs), laboratory testing, bone density and adrenal AEs were assessed. Exposure-adjusted incidence rates were calculated for AEs and AEs of special interest (AESIs). Results: Overall, 514 unique participants were included (BOS 2.0 mg b.i.d., n = 292; BOS any dose, n = 448; placebo, n = 168). The BOS 2.0 mg b.i.d., BOS any dose and placebo groups totalled 93.7, 122.4 and 25.0 participant-years of exposure

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Section: Discussionmentioning

confidence: 56%

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials

Hirano

Dellon

Gupta

et al. 2023

Aliment Pharmacol Ther

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“…The benefit versus existing ICS is the once-daily dosing regimen, which is believed to improve treatment adherence. Clinical trial data from fourteen studies support the safety profile of FF and favour FF over placebo for clinical outcomes including lung function, rescue inhaler use and exacerbations [7]. In addition, high single-dose (1000 mcg) FF protects against AMP-induced bronchoconstriction within 2 h of dosing, an effect that, although diminished, was still significant 24 h later [8].…”

Section: Introductionmentioning

confidence: 88%

“…adenosine monophosphate -AMP) acting stimuli [2][3][4][5]. ICS improve lung function, lower the frequency of exacerbations and decrease symptoms [6,7].…”

Section: Introductionmentioning

confidence: 99%

Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics

Okonkwo

Davis

Blais

et al. 2019

Respiratory Medicine

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Background: Inhaled corticosteroids (ICS) decrease airway inflammation and airway hyperresponsiveness (AHR). Previous studies have generally investigated the effect of ICS on methacholine-induced AHR following weeks or months of medium to high dose treatment. Purpose: The short-term effects of once-daily fluticasone furoate (FF) 100 mcg on methacholine-induced AHR and airway inflammation were examined over the course of one week. Methods: Eleven mild asthmatics completed this randomized, double-blind crossover study. Once-daily FF (100 mcg) and identical appearing placebo Ellipta® inhalers were given for 7 days with a 2-week washout. Methacholine challenges were performed before and 24 h after the first, third and seventh doses. Fractional exhaled nitric oxide (FeNO) was measured initially and at 7 days. Results: FF significantly (p = 0.0009-0.0078) increased methacholine PD 20 (provocative dose causing 20% fall in forced expiratory volume in 1 s) at all times. Doubling dose shifts (95% CI) were 1.23 (0.60-1.86), 1.17 (0.68-1.67) and 1.44 (0.93-1.94) after the first, third and seventh dose respectively. FeNO (geometric mean, 95% CI) decreased significantly (p = 0.0049) following FF treatment from 37.9 ppb (23.7-60.5) initially to 22.9 ppb (14.8-35.5) at 7 days. Placebo did not affect methacholine PD 20 or FeNO. Conclusion: Single-dose FF 100 mcg decreased methacholine AHR at 24 h without significant further improvement with continued daily use over 7 days. The inhibition in AHR after one week of daily dosing coincided with a significant decrease in FeNO at 7 days. Contrary to past assumptions, the ICS FF appears to rapidly reduce AHR to methacholine.

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“…An integrated safety and efficacy analysis study pooled data from 14 Phase II and Phase III studies and demonstrated FF efficacy compared with placebo 44 .…”

Section: Clinical Research Studiesmentioning

confidence: 99%

Fluticasone Furoate: A Once Daily Preparation in Patients with Persistent Asthma

Lilburn¹,

Ainge‐Allen²,

Thomas³

2019

J Lung Health Dis

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Asthma affects approximately 240 million people worldwide. It is characterised by an allergic pattern of smooth muscle constriction and airway inflammation, and if chronic, the inflammation can lead to structural changes and fixed airflow obstruction. Bronchodilators relieve the bronchoconstriction, while inhaled corticosteroids reduce the airway inflammation. This paper reviews fluticasone furoate (FF), a novel inhaled corticosteroid with 24-hour duration of action. It is a synthetic fluorinated corticosteroid with agonist activity at the glucocorticoid receptor (GRE). It is reported to have a fast association and slow dissociation from the GRE compared to other ICSs. FF has been found to have a greater lung retention time than all other ICS preparations which may contribute to the extended duration of anti-inflammatory action. FF has extensive first pass hepatic metabolism resulting in a low gastrointestinal bioavailability which is consistent with the findings for other ICS preparations. FF, however, will pass from the lung into the systemic circulation and therefore an adverse profile similar to all ICS is likely, but long term data are needed.FF has demonstrated treatment efficacy for asthma between 100μg and 200μg alone, but in combination with the long-acting beta agonist, vilanterol (FF/VIL 200μg/50μg OD) there were further improvements in lung function relative to monotherapy. There is an increased risk of pneumonia identified in patients with airways disease in associated with ICS preparations and surveillance will be required to determine if this also applies to FF. Once daily therapy, such as FF, may improve compliance and could hopefully be translated into further improvements in asthma-related outcomes.

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Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma

Cited by 10 publications

References 29 publications

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1–3 clinical trials

Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics

Fluticasone Furoate: A Once Daily Preparation in Patients with Persistent Asthma

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