Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma

Li, James T.C.; Ford, Linda; Chervinsky, Paul; Weisberg, Stephen C.; Kellerman, Donald J.; Faulkner, Kenneth G.; Herje, Nancy; Hamedani, Abbas G.; Harding, S. M.; Shah, Tushar

doi:10.1016/s0091-6749(99)70180-6

Cited by 74 publications

(22 citation statements)

References 30 publications

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“…The current study suggests that FP 1,000 mg?day -1 significantly decreased P1NP and serum osteocalcin, whereas the lower dose of FP and both doses of ICS did not. Long-term studies with FP, in which doses of 400-750 mg?day -1 were administered for 1-2 yrs, demonstrated no clinically relevant effect on markers of bone formation compared with baseline [35,36]. To the best of our knowledge, no studies with higher doses of FP have been performed to date.…”

Section: Discussionmentioning

confidence: 92%

Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma

Derom

Louis

Tiesler³

et al. 2009

Eur Respir J

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We compared the systemic and clinical effects of ciclesonide (CIC) and fluticasone propionate (FP) administered, in addition to CIC 160 mg?day -1 and salmeterol 50 mg twice daily, in 32 patients with persistent asthma using a randomised double-blind, placebo-controlled, doubledummy, five-period crossover design. All patients exhibited a provocative concentration leading to a 20% decrease in forced expiratory volume in 1 s (PC20) methacholine ,8 mg?mL -1 and a PC20 adenosine ,60 mg?mL -1 . Primary outcome was 24-h serum cortisol suppression after 7 days. Secondary outcomes were changes in PC20 methacholine and adenosine after 9 days.FP 500 mg?day : -38.8 (95% CI -75.7--1.9) nmol?L -1 ). Compared with placebo, the increase in PC20 adenosine after the four treatments was small, but significant. Greater improvements in PC20 adenosine were seen with FP 500 mg?day . For a similar decrease in hyperresponsiveness, cortisol secretion was suppressed significantly with moderate-to-high doses of fluticasone propionate, but not with ciclesonide.

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Section: Discussionmentioning

confidence: 92%

Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma

Derom

Louis

Tiesler³

et al. 2009

Eur Respir J

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“…Five studies were excluded in which subjects took either inhaled or intranasal corticosteroids at the time of recruitment or took concomitant intranasal corticosteroids during the period of the study [25][26][27][28][29]. There was one published study in which data were not in the required format [30], three studies in which adrenal function was assessed by urine cortisol assessment [28,31,32] and one study with a duration of 3 weeks [33].…”

Section: Resultsmentioning

confidence: 99%

Inhaled fluticasone propionate and adrenal effects in adult asthma: systematic review and meta-analysis

Masoli¹,

Weatherall²,

Holt³

et al. 2006

Eur Respir J

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The dose-response relationship of inhaled fluticasone propionate (FP) for adrenal suppression in adults with asthma is not clear.The current authors carried out a systematic review and meta-analysis of placebo-controlled randomised dose-response studies of o4 weeks' duration, which assessed the adrenal effects of FP by cosyntropin stimulation tests in adult asthma. The main outcome measure was the proportion of subjects with adrenal function below the lower limit of the normal range.Five studies, with a total of 732 subjects with asthma, met the inclusion criteria. Data on daily doses .1,000 mg were limited to one study. The proportion of subjects with adrenal function below the lower limit of the normal range on placebo was 3.9%; for a 500-mg per day increase in FP dose the odds of an abnormality increased by 1.38 (95% confidence interval 1.01-1.59). The continuous secondary outcome measures showed an inverse linear relationship with the FP dose up to 2,000 mg?day -1 .In conclusion, for routine prescribing within the established therapeutic dose-response range (50-500 mg?day -1 ), fluticasone propionate has minimal effects on adrenal function. This conclusion is limited by the paucity of long-term studies of daily doses of fluticasone propionate .1,000 mg and by the considerable individual variability in the response.

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“…All changes in 24-hour urinary cortisol values over the 12-week treatment period were within the same range for patients treated with fluticasone propionate as in patients treated with placebo with the exception that two fluticasone propionate patients (one low-dose, 88 µg bid; and one high-dose, 440 µg bid) had increases in cortisol excretion rates compared with baseline greater than any of the patients in the placebo group. In previous studies in which patients with asthma used non-HFA formulations of fluticasone propionate at daily doses of up to 1,000 µg for up to 2 years (15,16), effects on HPA-axis function, bone mineral density, and eyes were comparable to those in patients who received placebo.…”

Section: Discussionmentioning

confidence: 83%

Fluticasone Propionate HFA-134a Pressurized Metered-Dose Inhaler in Adolescents and Adults with Moderate to Severe Asthma

et al. 2005

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In this randomized, double-blind, placebo-controlled trial, 397 patients with moderate to severe asthma, previously treated with bronchodilators alone, received fluticasone propionate 88, 220, or 440 microg twice daily, or placebo via metered dose inhaler (MDI) for 12 weeks. Mean change from baseline to endpoint in pre-dose percent predicted forced expiratory volume in one second (FEV1) was greater (p < 0.001) in each fluticasone propionate group (9.0%, 88 microg bid; 9.8%, 220 microg bid; 11.2%, 440 microg bid) versus placebo (3.4%). Morning and evening peak expiratory flow (PEF), asthma symptoms, and supplemental albuterol use also improved in all fluticasone propionate groups versus placebo. The incidence of adverse events and 24-hour urine cortisol excretion rates were similar between active treatments and placebo.

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Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma

Cited by 74 publications

References 30 publications

Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma

Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma

Inhaled fluticasone propionate and adrenal effects in adult asthma: systematic review and meta-analysis

Fluticasone Propionate HFA-134a Pressurized Metered-Dose Inhaler in Adolescents and Adults with Moderate to Severe Asthma

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