A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. International Study Group

Barnes, Neil; Marone, Gianni; Maria, Giuseppe U. Di; Visser, Sandra A.G.; Utama, I Made Gede Dwi Lingga; Payne, SL

doi:10.1183/09031936.93.06060877

Cited by 137 publications

(3 citation statements)

References 16 publications

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“…Fluticasone propionate is a new, topically active, synthetic glucocorticosteroid which has been shown in both adults and children to be at least twice as clinically effective as beclomethasone dipropionate 10–13 . Fluticasone propionate has the added advantage over other currently available inhaled corticosteroids of having less than 1% oral bioavailability; hence there will be few or no systemic effects from the swallowed portion of the inhaled dose 9 , 24 .…”

Section: Discussionmentioning

confidence: 99%

“…Preclinical studies in healthy adult volunteers have demonstrated that fluticasone propionate has a higher local potency than existing inhaled corticosteroids, 8 and that it undergoes virtually complete first‐pass degradation by the liver to inactive metabolites 9 . In clinical studies in adults, fluticasone propionate has been shown to be at least twice as effective as beclomethasone dipropionate in improving lung function but with the same or a better safety profile 10–12 . In children, fluticasone propionate has also been compared with beclomethasone dipropionate 13 and shown to have greater efficacy with no significant adverse events or reduction in serum cortisols.…”

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confidence: 99%

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An Open Study to Assess the Long‐term Safety of Fluticasone Propionate in Asthmatic Children

MacKenzie

Tsanakas

Tabachnik

et al. 1994

Int J Clinical Practice

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SUMMARY This study was conducted to assess the long‐term safety of fluticasone propionate 50 μg twice daily (100 μg/day) or 100 μg twice daily (200 μg/day) administered via a dry powder inhaler in children aged 4–17 years with moderately severe asthma. A total of 257 patients received open treatment for 12 months. Of these, 110 had not received treatment with fluticasone propionate in any prior study. The remaining 147 patients had completed one of two previous short‐term inhaled fluticasone propionate studies. In all, 132 patients (51%) reported 273 adverse events, the pattern of which was as expected in an atopic population with asthma; only 26 (10%) of these reports were considered either certainly, probably or possibly related to study treatment. The events most commonly reported either as a single or multiple diagnosis were: asthma and related events (25%), upper respiratory tract infection (13%), and rhinitis (6%). For most patients who reported a worsening of asthma, additional therapy was all that was required to control symptoms, and they continued in the study. There was a low incidence (2%) of pharmacologically predictable adverse events. Eight patients (3%) withdrew from the study because of an adverse event, five of which events (one each of hypertension, hoarseness and asthma and two of oral candidiasis) were recorded as being possibly or probably drug‐related. Sixteen adverse events reported by 15 patients (6%) were classified as serious but none was considered to be related to the study drug. Of these reports 10 (9 patients; 4%) were exacerbations of asthma requiring hospital admission; the other six adverse events were unrelated to asthma. Fluticasone propionate was thus well tolerated during long‐term treatment in children, and asthma control was maintained over the 12 months.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

An Open Study to Assess the Long‐term Safety of Fluticasone Propionate in Asthmatic Children

MacKenzie

Tsanakas

Tabachnik

et al. 1994

Int J Clinical Practice

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“…Clinical asthma severity was rated as mild, moderate or severe using the integrated severity score described in the Australian Asthma Management Guidelines [6], which closely approximate the National Heart, Lungs and Blood Institute Guidelines [7]. Appropriate inhaler use and compliance was assessed in the Asthma Management Service [8].…”

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A Case Study of Stillbirth in a Pregnancy Complicated by Asthma

Clifton¹,

Busuttil²

2015

Obstet Gynecol Cases Rev

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Newcastle, NSW antenatal clinic during the first trimester, following a previously described protocol [5]. Clinical asthma severity was rated as mild, moderate or severe using the integrated severity score described in the Australian Asthma Management Guidelines [6], which closely approximate the National Heart, Lungs and Blood Institute Guidelines [7]. Appropriate inhaler use and compliance was assessed in the Asthma Management Service [8].

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Systemic Adverse Effects of Inhaled Corticosteroid Therapy

1999

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Objective: To appraise the data on systemic adverse effects of inhaled corticosteroids.Methods: A computerized database search from January 1, 1966, through July 31, 1998, using MEDLINE, EMBASE, and BIDS and using appropriate indexed terms. Reports dealing with the systemic effects of inhaled corticosteroids on adrenal gland, growth, bone, skin, and eye, and reports on pharmacology and pharmacokinetics were reviewed where appropriate. Studies were included that contained evaluable data on systemic effects in healthy volunteers as well as in asthmatic children and adults. A statistical meta-analysis using regression was performed for parameters of adrenal suppression in 27 studies.Results: Marked adrenal suppression occurs with high doses of inhaled corticosteroid above 1.5 mg/d (0.75 mg/d for fluticasone propionate), although there is a considerable degree of interindividual susceptibility. Metaanalysis showed significantly greater potency for doserelated adrenal suppression with fluticasone compared with beclomethasone dipropionate, budesonide, or triamcinolone acetonide, whereas prednisolone and fluticasone propionate were approximately equivalent on a 10:1-mg basis. Inhaled corticosteroids in doses above 1.5 mg/d (0.75 mg/d for fluticasone propionate) may be associated with a significant reduction in bone density, although the risk for osteoporosis may be obviated by postmenopausal estrogen replacement therapy. Although medium-term growth studies showed suppressive effects with 400-µg/d beclomethasone dipropionate, there was no evidence to support any significant effects on final adult height. Long-term, high-dose inhaled corticosteroid exposure increases the risk for posterior subcapsular cataracts, and, to a much lesser degree, the risk for ocular hypertension and glaucoma. Skin bruising is most likely to occur with high-dose exposure, which correlates with the degree of adrenal suppression.Conclusions: All inhaled corticosteroids exhibit doserelated systemic adverse effects, although these are less than with a comparable dose of oral corticosteroids. Metaanalysis shows that fluticasone propionate exhibits greater dose-related systemic bioactivity compared with other available inhaled corticosteroids, particularly at doses above 0.8 mg/d. The long-term systemic burden will be minimized by always trying to achieve the lowest possible maintenance dose that is associated with optimal asthmatic control and quality of life. Med. 1999;159:941-955 Arch Intern

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A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. International Study Group

Cited by 137 publications

References 16 publications

An Open Study to Assess the Long‐term Safety of Fluticasone Propionate in Asthmatic Children

An Open Study to Assess the Long‐term Safety of Fluticasone Propionate in Asthmatic Children

A Case Study of Stillbirth in a Pregnancy Complicated by Asthma

Systemic Adverse Effects of Inhaled Corticosteroid Therapy

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