Fluticasone at different doses for chronic asthma in adults and children

Adams, NP; Bestall, Janine C; Jones, P. W.; Lasserson, TJ; Griffiths, Benedict; Cates, Christopher J

doi:10.1002/14651858.cd003534.pub2

Cited by 32 publications

(33 citation statements)

References 52 publications

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“…12 In an earlier phase II study, FP 500 mg twice daily had a similar efficacy to FF 200 mg once daily (vs placebo) in patients with persistent moderate-to-severe asthma. 7 However, FP 500 mg twice daily is associated with more steroid-associated AEs than lower FP doses [13][14][15] and this dose of FP was therefore selected in our study as a benchmark to which FF/VI safety data could be compared. The patient population contained a wide age range (12-73 years) in order to adequately assess the safety and tolerability of FF/VI in adolescent and adult patients with asthma.…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Busse

O'Byrne

Bleecker

et al. 2013

Thorax

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BackgroundThe inhaled corticosteroid fluticasone furoate (FF) in combination with the long-acting β2 agonist vilanterol (VI) is in development for asthma and chronic obstructive pulmonary disease.ObjectiveTo assess the safety and tolerability of FF/VI over 52 weeks in patients with asthma.MethodsPatients (aged ≥12 years; on inhaled corticosteroid) were randomised (2:2:1) to FF/VI 100/25 µg or FF/VI 200/25 µg once daily in the evening, or fluticasone propionate (FP) 500 µg twice daily. Safety evaluations included adverse events (AEs), non-fasting glucose, potassium, 24-h urinary cortisol excretion, ophthalmic assessments, heart rate and pulse rate.ResultsOn-treatment AEs were similar across groups (FF/VI 66–69%; 73% FP). Oral candidiasis/oropharyngeal candidiasis was more common with FF/VI (6–7%) than FP (3%). Twelve serious AEs were reported; one (worsening hepatitis B on FP) was considered drug related. Statistically significant cortisol suppression was seen with FP compared with both FF/VI groups at Weeks 12 and 28 (ratios [95% CI] to FP ranged from 1.43 [1.11 to 1.84] to 1.67 [1.34 to 2.08]; p≤0.006), but not at Week 52 (ratios to FP were 1.05 [0.83 to 1.33] for FF/VI 100/25 µg and 1.09 [0.87 to 1.38] for FF/VI 200/25 µg). No clinically important changes in non-fasting glucose, potassium, QT interval corrected using Fridericia's formula (QTc[F]) or ophthalmic assessments were reported. Pulse rate (10 min post dose [Tmax], Week 52) was significantly increased with FF/VI versus FP (3.4 bpm, 95% CI 1.3 to 5.6; p=0.002 [FF/VI 100/25 µg]; 3.4 bpm, 95% CI 1.2 to 5.6; p=0.003 [FF/VI 200/25 µg]). Mean heart rate (24-h Holter monitoring) decreased from screening values in all groups (0.2–1.1 bpm FF/VI vs 5 bpm FP; Week 52).ConclusionsFF/VI (100/25 µg or 200/25 µg) administered once daily over 52 weeks was well tolerated by patients aged ≥12 years with asthma. The overall safety profile of FF/VI did not reveal any findings of significant clinical concern.ClinicalTrials.govNCT01018186

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Section: Discussionmentioning

confidence: 99%

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Busse

O'Byrne

Bleecker

et al. 2013

Thorax

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“…The efficacy of inhaled fluticasone and of inhaled formoterol is well established, both as individual therapies and as part of single inhaler ICS/LABA combination therapies (23,24,(35)(36)(37)(38)(39). Prescribing data indicate that fluticasone and formoterol are already co-prescribed and used concurrently in patients with asthma (MIDAS database, IMS Health, London, UK), and now these components have been combined in a single inhaler.…”

Section: Discussionmentioning

confidence: 99%

“…Fluticasone propionate (fluticasone) is an ICS with potent and sustained anti-inflammatory effects and has a well-established efficacy and safety profile (20)(21)(22)(23)(24). Formoterol fumarate (formoterol) is the only LABA approved for use in asthma with both a fast onset of action (between 1 and 3 minutes) and a prolonged bronchodilatory effect (25)(26)(27)(28)(29).…”

Section: Introductionmentioning

confidence: 99%

Fluticasone/Formoterol Combination Therapy versus Budesonide/Formoterol for the Treatment of Asthma: A Randomized, Controlled, Non-Inferiority Trial of Efficacy and Safety

Bodzenta-Łukaszyk

Buhl²,

Bálint³

et al. 2012

Journal of Asthma

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“…The plateau of the dose-response curve for ICS is reported to be 200–500 μg/day FP equivalent 24–27. There is some evidence that increasing to very high doses of FP (2000 μg/day) or budesonide (1600 μg/day) may afford some clinical benefit in very severe asthma 24 25. However, this evidence is largely derived from adult studies and there is a lack of data in children with severe asthma on the inflammatory response to high-dose ICS.…”

Section: Discussionmentioning

confidence: 99%

Use of sputum eosinophil counts to guide management in children with severe asthma

Fleming

Wilson

Regamey

et al. 2011

Thorax

112

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Background Previous studies in adults with asthma incorporating the control of sputum eosinophils into management strategies have shown significant reductions in exacerbations. A study was undertaken to investigate whether this strategy would be successful in children with severe asthma. Methods 55 children (7e17 years) with severe asthma were randomised to either a conventional symptombased management strategy or to an inflammationbased strategy (principally sputum eosinophils). Children were seen 3-monthly over a 1-year period.Results The annual rate of total and major exacerbations (courses of oral corticosteroids) was non-significantly lower in the inflammatory management group compared with the symptom management group (3.6 vs 4.8, incident rate ratio (IRR) 0.75, 95% CI 0.54 to 1.04, p¼0.082; and 1.9 vs 2.7 IRR 0.73, 95% CI 0.42 to 1.28, p¼0.274 for total and major exacerbations, respectively). Significantly fewer subjects in the inflammatory management group experienced an exacerbation within 28 days of a study visit. There were small non-significant differences in measures of asthma control (symptom-free days and short-acting b agonist use) favouring the inflammatory management group. There was no significant difference in the inhaled corticosteroid dose prescribed over the course of the study. Conclusion Incorporating the control of sputum eosinophils into the management algorithm did not significantly reduce overall exacerbations or improve asthma control. Exacerbations were reduced in the short term, suggesting that more frequent measurements would be needed for a clinically useful effect and that controlling inflammation may have a role to play in subgroups of children with severe asthma.

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Fluticasone at different doses for chronic asthma in adults and children

Cited by 32 publications

References 52 publications

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Fluticasone/Formoterol Combination Therapy versus Budesonide/Formoterol for the Treatment of Asthma: A Randomized, Controlled, Non-Inferiority Trial of Efficacy and Safety

Use of sputum eosinophil counts to guide management in children with severe asthma

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Fluticasone at different doses for chronic asthma in adults and children

Cited by 32 publications

References 52 publications

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Fluticasone/Formoterol Combination Therapy versus Budesonide/Formoterol for the Treatment of Asthma: A Randomized, Controlled, Non-Inferiority Trial of Efficacy and Safety

Use of sputum eosinophil counts to guide management in children with severe asthma

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Resources

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Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial

Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β₂agonist vilanterol administered once daily for 52 weeks in patients ≥12 years old with asthma: a randomised trial