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PubMed1982

Plasma glucose and insulin responses to propionate in preruminating calves.

Eighteen preruminating calves obtained at approximately 38 d of age were used to determine whether the ruminant insulin response to propionate is an inherent response or one that is acquired because of ruminal propionate production. A liquid milk replacer diet was fed alone or with isocaloric additions of propionate [50 mmol . (kg BW . 75-1 . d-1] or glucose. Both additions caused a strong insulin response, but the response by propionate-fed calves appeared to be independent of plasma glucose concentrations during the early post-feeding hours. After receiving the experimental diets for 18 d, all calves were given an iv infusion or propionate [.035 mmol propionate . (kg BW . 75-1 . min-1 for 20 min]. All calves demonstrated a plasma insulin rise and glucose decline due to the infusions, but glucose-fed and propionate-fed calves appeared less sensitive to the iv propionate than the calves fed only milk replacer.

Age Factors↗
PubMed1988

Effect of propionate level in a volatile fatty acid salt mixture fed to lambs on weight gain, body composition and plasma metabolites.

Chopped hay supplemented with a volatile fatty acid salt mixture at 20% of metabolizable energy (ME) was fed to 30 Suffolk X Corriedale lambs (mean wt 29.6 kg) to determine the effects of dietary propionate on weight gain, body composition and plasma metabolites. Propionate accounted for 0, 25, 50, 75 or 100% of the salt mixture energy, and acetate accounted for the remainder. Each diet was fed at two levels of daily intake (158.7 and 130.6 kcal ME/W.75). Lambs on the high level of intake lost more (P less than .05) energy in feces, lost less (P less than .05) energy in CH4 and had carcasses with more (P less than .10) water and fat than lambs on the low intake level. Percentage of propionate in the salt mixture had no effect on ME or body composition of lambs. Increasing the percentage of propionate in the salt mixture increased plasma propionate in blood samples taken at 1 and 2 h after feeding (linear, P less than .05). Empty body weight gain per megacalorie of ME above maintenance increased as the percentage of propionate in the salt mixture increased, but not until propionate reached 75% of the salt mixture (linear, P less than .05; cubic, P less than .05). These results show that propionate in the blood has a positive, but nonlinear, effect on weight gain, even when energy intake is held constant.

Animals↗
PubMed1985

Measures of de novo synthesis of milk components from propionate in lactating goats.

Possible direct contributions of propionate to de novo synthesis of milk components by the mammary gland of lactating goats fed a concentrate-roughage diet have been studied in vivo by primed constant infusion of [1-carbon-14]propionate into the right mammary artery. Specific radioactivities of milk galactose, fatty acids, and protein were higher in the infused than in the uninfused half of the mammary gland, suggesting de novo synthesis of these compounds in the udder. Specific radioactivities of milk glucose in both udder halves were identical, ruling out any possibility of mammary gland-derived glucose from propionate of blood plasma under the experimental conditions. Of milk galactose, .8% was derived from propionate of blood plasma, and of milk glucose, 98% was derived from glucose of blood plasma. After intraruminal infusion of unlabeled propionic acid at 11 g/h, concentration of propionate in blood plasma was doubled, its contribution to milk galactose was increased to 1.5%, and proportions of milk odd-numbered fatty acids were increased. Propionate was incorporated largely into milk odd-numbered fatty acids (9:0, 11:0, 13:0, 15:0, 17:0). We conclude that small amounts of propionate can be incorporated into principal components of milk in the mammary gland of lactating goats.

Animals↗
PubMed1994

Effects of reduced phenolic acids on metabolism of propionate and palmitate in bovine liver tissue in vitro.

Benzoic acid, 3-phenylpropionic acid, trans-cinnamic acid, and 3-(4-hydroxyphenyl)propionic acid in ruminal fluid are presumed to be the products of chemical reduction of dietary phenolic monomers by ruminal microorganisms. Effects of reduced phenolics on metabolism in bovine liver tissue were evaluated by measurement of 1) conversion of propionate to glucose and CO2, 2) conversion of palmitate to oxidized products, and 3) leakage of lactate dehydrogenase from liver slices in vitro. In Experiment 1, .4 mM benzoic, 3-phenylpropionic, trans-cinnamic, or 3-(4-hydroxyphenyl)propionic acids decreased conversion of propionate to glucose and decreased conversion of palmitate to total oxidation products. At .2 mM, 3-(4-hydroxyphenyl)propionic acid did not inhibit conversion of propionate to glucose compared with that of controls, but the other reduced phenolics did. In Experiment 2, the same reduced phenolics inhibited conversion of propionate to glucose. Of the reduced phenolics tested, cinnamic acid inhibited conversion of propionate to glucose at the lowest concentration, .1 mM. Additionally, when present at > or = .4, .1, or .005 mM, benzoic, 3-phenylpropionic, or trans-cinnamic acids, respectively, increased leakage of lactate dehydrogenase from liver tissue. The reduced phenolics tested, which are representative of those in ruminal fluid, inhibited metabolism of bovine liver tissue in vitro at supraphysiological concentrations. Data at physiological concentrations were inconclusive.

Animals↗
PubMed1996

Field trials of an oral calcium propionate paste as an aid to prevent milk fever in periparturient dairy cows.

Trials were conducted to test the efficacy of a calcium propionate paste as an aid to prevent milk fever and to improve the health of dairy cows. Each calcium propionate treatment tube supplied 37 g of calcium. In trials involving Holstein herds and a Jersey herd, two (trials 1 and 2) or three (trial 3) calcium propionate tubes were given at calving and again at 12 h after calving. For the Jersey herd, calcium propionate treatment (two tubes) reduced the incidence of milk fever from 50% in control cows to 29% in treated cows. Plasma obtained 24 h after calving from treated cows had higher calcium, lower NEFA, and lower beta-hydroxybutyrate concentrations than did plasma from control cows. No other benefits of calcium propionate treatment were significant for health or for productivity of the cows. Calcium propionate treatment had no significant effects on blood calcium, NEFA, or beta-hydroxybutyrate in the Holstein herds studied. However, calcium propionate did reduce the number of cows with subclinical hypocalcemia (< or = 7.5 mg/dl of plasma calcium) at 24 h after calving in both trials involving Holstein cows. Calcium propionate treatment was beneficial in reducing subclinical hypocalcemia in all trials and reduced the incidence of milk fever in a herd having a problem with milk fever.

3-Hydroxybutyric Acid↗
PubMed1995

Effects of intravenous injection and intraperitoneal continual administration of sodium propionate on serum cholesterol levels in rats.

To examine the effects of sodium propionate on serum cholesterol levels, rats were given sodium propionate intravenously and intraperitonealy. Six-week-old male Sprague-Dawley rats were kept on a cholesterol-free semisynthetic diet for 2 weeks, fasted, and given 400 microliters of saline solution intravenously supplemented with 0.01-10 mg sodium propionate. Three hours after injection of 1 mg of sodium propionate, the serum total-cholesterol level was significantly reduced (85.4 +/- 4.0 mg/dl) compared with its starting level (102 +/- 3.4 mg/dl), with the reducing effect lasting for 24 h. The intensity of the reduction increased proportionately with increased sodium propionate concentrations from 0.01 to 1 mg. Next, to evaluate the influence of continual sodium propionate administration on serum cholesterol levels, 6-week-old male rats were implanted with an osmotic pump intraperitonealy (ALZET Model 2ML2, pumping rate: 5.0 microliter/h; duration: 14 days; reservoir volume: 2,000 microliters). At day 14, serum total-cholesterol levels were reduced by continual sodium propionate administration at both 0.12 and 1.2 mg/day. The maximum percentage change in the serum total-cholesterol level was 78.5 +/- 6.7% of its starting level (111 +/- 7.1 mg/dl), observed at 1.2 mg/day at day 7. These results indicate that sodium propionate can reduce serum total-cholesterol levels in vivo.

Animals↗
PubMed1984

Propionate may mediate the hypocholesterolemic effects of certain soluble plant fibers in cholesterol-fed rats.

The effects of propionate on serum and liver lipid concentrations were studied in cholesterol-fed rats. Both serum and liver cholesterol levels were significantly lower in rats fed the cholesterol-propionate diet than in rats fed the cholesterol diet without propionate. Liver triglyceride levels were also significantly lower in the propionate-treated group. Serum triglyceride concentrations were not influenced by the propionate feeding. Propionate intake was not associated with histologic changes in liver tissue. This study indicates that 0.5% sodium propionate-supplemented diets slightly but significantly reduced cholesterol accumulation in both serum and liver of cholesterol-fed rats. Thus propionate, a metabolic product of fiber fermentation, may mediate some of the hypocholesterolemic effects of certain soluble plant fibers.

Animals↗
PubMed1997

Adrenal suppression with high doses of inhaled fluticasone propionate and triamcinolone acetonide in healthy volunteers.

STUDY OBJECTIVE: This study was conducted to compare the adrenal suppression of inhaled fluticasone propionate and triamcinolone acetonide in healthy volunteers, both given via their respective pressurised metered dose inhaler (pMDI) devices at high doses within the manufacturers recommended dose range. DESIGN: We used a single (investigator) blind, randomised, crossover design comparing a total daily dose of 1.625 mg fluticasone propionate delivered via a pMDI, 1.60 mg daily of triamcinolone acetonide delivered via a pMDI with integrated spacer, or placebo pMDI; each drug was given in two divided doses at 0800 hours and 2200 hours over a 24-h period. Each drug treatment was separated by a 1-week washout. PATIENTS: Twelve normal subjects mean age 27.5 years were studied. MEASUREMENTS: Blood samples were taken for 0800 hours plasma cortisol, i.e. 10 h following the second dose. Ten hour urine collections (2200 hours until 0800 hours) were taken for urinary cortisol and creatinine excretion. RESULTS: For the 0800 hours plasma cortisol (geometric mean, nmol.1(-1) compared with placebo (353) fluticasone propionate (138) produced significant (P < 0.05) suppression (2.57-fold difference), whereas triamcinolone acetonide (263) did not (1.34-fold difference). Fluticasone propionate produced a 1.91-fold greater adrenal suppression than triamcinolone acetonide (95% CI 1.10 to 3.33). Individual subjects with abnormally low 0800 hours cortisol values < 150 nmol.1(-1) (< 5.4 micrograms/dl) were n = 4 for fluticasone propionate and n = 0 for triamcinolone acetonide. Overnight urinary cortisol/creatinine ratio (geometric mean, nmol/mmol) did not show any difference between fluticasone propionate (1.48) and triamcinolone acetonide (1.60), with both producing significant suppression versus placebo (4.01): triamcinolone acetonide 2.50-fold difference (95% CI 1.45-4.24); fluticasone propionate 2.71-fold difference (95% CI 1.57-4.69). CONCLUSION: Fluticasone propionate 1.625 mg/day (pMDI) produced an approximately two-fold greater adrenal suppression of 0800 hours plasma cortisol than triamcinolone acetonide 1.60 mg per day (Oral Inhaler) when given twice daily, and one third of subjects with fluticasone had abnormally low 0800 hours cortisol values < 150 nmol.1(-1) (< 5.4 micrograms.dl-1. There were no differences between the drugs for urinary cortisol excretion. Further dose-ranging studies are required at steady-state in asthmatic subjects in order to see whether differences occur at lower doses on the steep part of the dose-response curve for both plasma and urinary cortisol suppression.

Administration, Inhalation↗
PubMed2002

Budget impact model for determining the costs of introducing inhaled salmeterol/fluticasone propionate combination for the management of persistent asthma in France.

A budget impact model was used to estimate the effect of introducing inhaled salmeterol/fluticasone propionate combination on asthma drug-related costs in France. The model is based on disease prevalence, drug use, drug acquisition cost and sales forecasting data specific to France. It takes the perspective of social security and has a time horizon of 1 year. All drug acquisition costs are adjusted for the average rate of reimbursement of asthma medications in France (77.3%). All costs are expressed in euros. The model shows that if patients receiving concurrent salmeterol plus fluticasone propionate (or budesonide plus formoterol switch to combined salmeterol/fluticasone propionate, the anticipated annual savings would be 2,691,580 and 1,916,966 euros, respectively. On a fixed budget 4067 additional patients could be treated if salmeterol/fluticasone propionate is substituted for concurrent salmeterol plus fluticasone propionate and an additional 2939 patients if the combination is used to replace concurrent budesonide plus formoterol. Overall, using sales forecasting data to estimate how many patients will switch to the new combination from their current therapy, it is estimated that the introduction of salmeterol/fluticasone propionate will increase the national expenditure in France on asthma medications by a maximum of 3%. This budget impact model shows that the introduction of inhaled salmeterol/fluticasone propionate combination is likely to have minimal impact on asthma-related medication costs in France. Moreover, the available data on the salmeterol/fluticasone propionate combination suggest that it is clinically effective, cost-effective and affordable to the French healthcare system.

Journal Article↗
PubMed1983

Induction of male sex behavior in pony mares with testosterone propionate.

Two pony mares were administered 150 mg of testosterone propionate every other day for 20 days (ten injections) and every ten days there-after. An additional two mares and one stallion were not treated and served as controls. Testosterone propionate was dissolved in absolute ethanol and administered subcutaneously. Sex behavior tests were conducted 26 and 40 days after the first injection. Control mares exhibited very little male sex behavior. Both testosterone propionatetreated mares, however, exhibited mounting, sniffing, flehmen, biting and vocalization behavior in the presence of an estrous mare. The testosterone propionate-treated mares mounted and bit estrous mares more frequently than the stallion but exhibited less sniffing, flehmen and vocalization behavior in the presence of an estrous mare than the stallion. Testosterone propionate-treated mares and the stallion mounted an estrous mare 23.3 +/- 9.7 seconds and 172.5 +/- 22.5 seconds, respectively, after being introduced into the pen. Mares in estrus were mounted by the testosterone propionate-treated mares and the stallion an average of 4.0 +/- 1.3 and 1.0 +/- 0 times, respectively, during a ten-minute test. None of the non-estrous mares was ever mounted by the testosterone propionate-treated mares. In summary, testosterone propionate induced male sex behavior in intact mares and the testosterone propionate-treated mares effectively detected estrous mares.

Journal Article↗
PubMed2005

Simultaneous determination of buprenorphine and its prodrug, buprenorphine propionate, by high-performance liquid chromatography with fluorescence detection: application to pharmacokinetic studies in rabbits.

A rapid, sensitive, precise and accurate high-performance liquid chromatographic assay with fluorescence detection was developed for the simultaneous determination of buprenorphine and buprenorphine propionate in human and animal blood. Buprenorphine propionate was also proven to be a prodrug of buprenorphine. It was comprised of only a one-step extraction procedure with ethyl acetate and normal-phase chromatography on a Betasil Silica column. The recoveries of buprenorphine and buprenorphine propionate were above 84%. Calibration graphs were linear for buprenorphine over the concentration range 2-1500 ng/ml and for buprenorphine propionate over the concentration range 20-1500 ng/ml with a coefficient of variation, both within- and between-day, or less than 10% at any level. The limits of quantitation of buprenorphine and buprenorphine propionate in human or animal blood were 2.0 and 20 ng/ml, respectively, based on a single-to-noise ratio of 3. The method has been successfully applied to pharmacokinetic studies of buprenorphine and buprenorphine propionate in rabbits. The results demonstrated that buprenorphine propionate was rapidly and totally converted to its parent drug, buprenorphine, following intravenous administration. Buprenorphine propionate is a prodrug of buprenorphine.

Animals↗
PubMed1998

Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in a large pediatric population with persistent asthma.

BACKGROUND: Inhaled corticosteroids are increasingly being used to treat mild-to-moderate asthma in children. However, data regarding therapy with this class of compounds, especially in children under age 6 years, is limited. Fluticasone propionate is a third generation inhaled corticosteroid with an optimal therapeutic index. Few large prospective clinical trials have been conducted to evaluate the efficacy and safety of fluticasone propionate powder in children. OBJECTIVE: We sought to determine the efficacy and safety of fluticasone propionate powder administered by means of the Diskus and Diskhaler multidose powder inhalers in pediatric patients with persistent asthma. METHODS: Fluticasone propionate powder (50 microg or 100 microg twice daily) or placebo was administered by means of the Diskus or Diskhaler inhalers to 437 children (4 to 11 years old) with persistent asthma for 12 weeks in a randomized, double-blind, parallel-group, multi-center trial. Patients were stratified according to whether they were receiving prior treatment with inhaled corticosteroids or cromolyn or beta2-agonists alone. RESULTS: Fluticasone propionate powder administered by means of Diskus or Diskhaler significantly improved FEV1 (mean increase from baseline of 0.22 to 0.24 L; p < or = 0.023), clinic morning peak expiratory flow (mean increase from baseline of 48 to 55 L/min; p < or = 0.006), patient-measured morning (p < or = 0.001) and evening (p < or = 0.003) peak expiratory flow, and asthma symptom scores (in all but the 50 microg Diskus group; p < or = 0.036), as well as reduced albuterol use (p < or = 0.002) and nighttime awakenings (p < or = 0.019) at endpoint. Efficacy parameters were not significantly different between the two doses with either device. More placebo-treated patients discontinued the study because of lack of efficacy than patients in any fluticasone propionate group (p < 0.001). Fluticasone propionate did not suppress morning plasma cortisol concentrations and did not affect 24-hour urinary free-cortisol excretion. Adverse events were primarily pharmacologic effects of inhaled corticosteroids, and those related to the study drug occurred with low frequency. Patient satisfaction with both the Diskus and Diskhaler devices was high, with a majority of patients (> 80%) rating them favorably. CONCLUSION: This study demonstrated that fluticasone propionate powder, at the conventional recommended doses of up to 200 microg/day administered by means of Diskus or Diskhaler, was well tolerated and improved lung function in children even as young as 4 and 5 years old regardless of whether they were previously treated with inhaled corticosteroids or cromolyn or beta2-agonists alone.

Administration, Inhalation↗
PubMed2001

A review of the pharmacology and pharmacokinetics of inhaled fluticasone propionate and mometasone furoate.

BACKGROUND: Fluticasone propionate is an established corticosteroid administered intranasally for the treatment of rhinitis or by oral inhalation for the treatment of asthma. Mometasone furoate, a closely related corticosteroid currently available in an intranasal formulation, is being investigated in an oral inhalation formulation for the treatment of asthma. OBJECTIVE: This article reviews available data on the comparative structure-activity relationships, chemistry, pharmacology, pharmacokinetics, and systemic bioavailability of fluticasone propionate and mometasone furoate to assess whether claims of differences in the absolute systemic bioavailability of the 2 compounds are supported by the published literature. METHODS: Information for this review was identified through a MEDLINE search of the literature from 1966 to the present that contained the term mometasone or fluticasone. The resulting list was narrowed by excluding articles dealing with dermatologic applications. A systematic review was conducted of the identified literature pertaining to the molecular structure, topical potency, lipophilicity, pharmacokinetics, and bioavailability of the 2 agents. Additionally, the pharmacology of the 2 moieties was assessed by a review of the available literature on receptor binding affinity, transactivation and transrepression potency, and inhibition of inflammatory-cell cytokine expression. RESULTS: Based on the available data, fluticasone propionate and mometasone furoate have similar physicochemical properties and structure-activity relationships. When administered intranasally, mometasone furoate is reported to have comparable relative systemic bioavailability to that of fluticasone propionate (mean plasma area under the curve, 123 pmol x h/L vs 112 pmol x h/L, respectively). When administered as a single dose by dry powder inhaler, orally inhaled fluticasone propionate is reported to have a total systemic bioavailability of approximately 17%, whereas that of mometasone furoate is reported to be < 1%. However, the mometasone furoate bioavailability study that reported the latter value used lower drug doses and a less sensitive assay than the fluticasone propionate bioavailability study. When multiple-dose data were used, mometasone furoate had an estimated 11% systemic bioavailability, similar to that of fluticasone propionate. CONCLUSIONS: Inhaled fluticasone propionate and mometasone furoate appear to have comparable potential systemic absorption and, based on the total systemic bioavailabilities of the parent compounds, have a low potential for systemic side effects at the recommended clinical doses. However, in the case of mometasone furoate, the contribution of the active metabolites to systemic effects has not been adequately assessed.

Administration, Intranasal↗
PubMed1993

Evaluation of fluticasone propionate (500 micrograms day-1) administered either as dry powder via a Diskhaler inhaler or pressurized inhaler and compared with beclomethasone dipropionate (1000 micrograms day-1) administered by pressurized inhaler.

Five hundred and eighty-five patients with moderate asthma, currently receiving 400-1000 micrograms day-1 of an inhaled corticosteroid, were treated for 6 weeks in a double-blind, randomized, parallel group study with either 500 micrograms day-1 fluticasone propionate as a dry powder via a Diskhaler inhaler, 500 micrograms day-1 fluticasone propionate via a pressurized inhaler or 1000 micrograms day-1 beclomethasone dipropionate via a pressurized inhaler. For all three treatment groups, mean morning and evening peak expiratory flow rates (PEFRs) increased within 1 week of the start of treatment. There were also improvements in clinic lung function, daytime and night-time asthma symptoms and a reduction in daytime and night-time rescue bronchodilator medication in all three groups. There were no statistically significant differences between the two formulations of fluticasone propionate in any of the efficacy parameters. Fluticasone propionate via the Diskhaler was significantly more effective than beclomethasone dipropionate over the 6 week study period in reducing diurnal variation (mean difference--4 l min-1, 95% CI--8 to 0 l min-1: P = 0.03). Fluticasone propionate via the Diskhaler produced a statistically significant improvement in night-time symptoms when compared to beclomethasone dipropionate whereas, beclomethasone dipropionate 1000 micrograms day-1 was statistically significantly more effective than both formulations of fluticasone propionate in improving daytime symptoms (P < 0.05). However, these statistical differences must be viewed together with the fact that very few patients recorded a score of 2 or more for both daytime or night-time symptoms. There was a similarly low incidence of adverse events with all three treatments with no evidence of hypothalamic pituitary adrenal (HPA)-axis suppression. The results of the 6-week comparative study showed that 500 micrograms day-1 fluticasone propionate whether administered via pressurized inhaler or Diskhaler is as effective and as safe as 1000 micrograms day-1 beclomethasone dipropionate administered via a pressurized inhaler in the treatment of moderate asthma. Over 12 months fluticasone propionate 500 micrograms day-1 via a pressurized inhaler was at least as effective and as well tolerated as beclomethasone dipropionate 1000 micrograms day-1.

Adolescent↗
PubMed1999

Salmeterol/fluticasone propionate (50/500 microg) in combination in a Diskus inhaler (Seretide) is effective and safe in the treatment of steroid-dependent asthma.

This multicentre double-blind, double-dummy study compared the safety and efficacy of a new combination Diskus inhaler containing both salmeterol 50 microg and fluticasone propionate 500 microg (Seretide, GlaxoWellcome, France) with the same doses of the two drugs delivered via separate Diskus inhalers and with the same dose of fluticasone propionate alone. Patients were eligible for study entry if they had received an inhaled corticosteroid continuously for 12 weeks prior to run-in, and had received treatment with beclomethasone dipropionate or budesonide 1500-2000 microg day(-1) or fluticasone propionate 750-1000 microg day(-1) for at least 4 weeks prior to run-in. In total, 503 patients receiving inhaled corticosteroids were randomized to 28 weeks' treatment with either salmeterol/fluticasone propionate (50/500 microg) via a single Diskus inhaler (combination) and placebo, or salmeterol 50 microg and fluticasone propionate 500 microg administered via separate Diskus inhalers (concurrent), or fluticasone propionate 500 microg and placebo. All treatments were administered twice daily, mean morning peak expiratory flow rate (PEFR) and asthma symptoms were measured for the first 12 weeks and safety data were collected throughout the 28-week study. Over weeks 1 to 12, improvement in adjusted mean morning PEFR was 35 and 33 l min(-1), respectively, in the combination and concurrent therapy treatment groups (12 and 10% increase from baseline, respectively). The mean difference between treatments was -3 l min(-1) (90% confidence interval -10.4 l min(-1)) which was within the criteria for clinical equivalence. However, the combination therapy was statistically significantly superior to fluticasone propionate alone for mean morning PEFR (P<0.001) and other measures of lung function, whilst clinical equivalence of the combination and concurrent therapies was observed. All three treatments were well tolerated. In addition, there were no differences between the three treatments in either the c.hange in serum cortisol or urinary cortisol concentrations, which, for each treatment group, were no significantly different from baseline at the end of the treatment period. Thus, the combination of salmeterol and fluticasone propionate in a single inhaler is as well tolerated and effective in achieving asthma control in steroid-dependent patients as the separate administration of the two drugs, and both combination and concurrent therapy are superior to administration of the same dose of corticosteroid alone.

Administration, Inhalation↗
PubMed2006

Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids.

BACKGROUND: Inhaled corticosteroids (ICSs) delivered by metered-dose inhalers that contain chlorofluorocarbon propellants are being discontinued because of the harmful effects of chlorofluorocarbon on the ozone layer. Therefore, some metered-dose inhaler products are being reformulated with "ozone-friendly" hydrofluoroalkane propellants. OBJECTIVE: To evaluate treatment with fluticasone propionate hydrofluoroalkane inhalation aerosol, 88, 220, and 440 microg twice daily, vs placebo in patients with asthma receiving an ICS. METHODS: Randomized, double-blind, parallel-group, 12-week study. RESULTS: Mean morning predose percent predicted forced expiratory volume in 1 second increased by 2.2%, 3.2%, and 4.6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, compared with an 8.3% decrease for placebo (P < .001 vs placebo for all groups). Secondary pulmonary function end points and asthma symptoms showed similar improvements compared with placebo. Discontinuation from the study due to lack of efficacy was 50% in the placebo group and 11%, 10%, and 6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively. At week 12, the probability of remaining in the study was 0.89, 0.90, and 0.94 for the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, vs 0.45 for the placebo group (P < .001 for all). Changes in 24-hour urinary cortisol excretion rates were similar among treatment groups. CONCLUSIONS: Fluticasone propionate hydrofluoroalkane, previously shown to be a clinically suitable alternative to fluticasone propionate chlorofluorocarbon, was effective and well tolerated. The ability to switch from fluticasone propionate chlorofluorocarbon and other chlorofluorocarbon-containing ICSs to fluticasone propionate hydrofluoroalkane without sacrificing asthma control or tolerability will facilitate a smooth transition to this nonchlorofluorocarbon-containing medicinal.

Administration, Inhalation↗
PubMed2004

Effects of high-dose inhaled fluticasone propionate on the hypothalamic-pituitary-adrenal axis in asthmatic patients with severely impaired lung function.

BACKGROUND: The effects of high-dose fluticasone propionate therapy on dynamic cortisol stimulation in severe asthma are unknown. OBJECTIVE: To evaluate the human corticotropin-releasing factor (hCRF)-stimulated plasma cortisol response to fluticasone propionate therapy in severe asthmatic patients with impaired airway caliber (forced expiratory volume in 1 second [FEV1] < 60% of predicted) and in control subjects. METHODS: Ten severe asthmatic patients (mean FEV1, 47% of predicted) and 10 controls (mean FEV1, 104% of predicted) received fluticasone propionate, 2,000 microg/d, via a 750-mL primed spacer for 2 weeks. Plasma cortisol levels before and after hCRF stimulation and overnight 10-hour urinary cortisol excretion corrected for creatinine concentration (OUCC) were measured at baseline after washout and 12 hours after the last dose of fluticasone propionate. RESULTS: Baseline values before fluticasone propionate use were not significantly different in asthmatic patients vs controls for plasma cortisol before and after hCRF stimulation and OUCC. Comparing values at baseline vs after fluticasone propionate use, there was no significant suppression of plasma cortisol levels before (378.2 vs 357.4 nmol/L) or after (510.5 vs 507.9 nmol/L) hCRF stimulation or OUCC (8.2 vs 7.5 nmoL/mmoL) in asthmatic patients. In controls, all outcomes were significantly suppressed comparing values before vs after fluticasone propionate therapy: plasma cortisol levels before (423.5 vs 200.2 nmol/L; P = .002) and after (503.5 vs 291.1 nmol/L; P = .001) hCRF stimulation and OUCC (6.5 vs 2.4 nmol/mmol; P = .002). CONCLUSION: Patients with severe persistent asthma and impaired airway caliber seem to be protected from developing systemic adverse effects with high-dose fluticasone propionate therapy, as evaluated by basal and dynamic measures of hypothalamic-pituitary-adrenal axis activity.

Adult↗
PubMed1997

Fluticasone propionate aqueous nasal spray in the treatment of nasal polyposis.

BACKGROUND: Topical glucocorticoids are the medical treatment of choice in a majority of patients suffering from nasal polyposis. Fluticasone propionate is a fluorinated steroid reported to be highly effective when used topically in the nose for seasonal and perennial allergic and nonallergic rhinitis. OBJECTIVES: To evaluate the efficacy and tolerability of intranasal fluticasone propionate in the treatment of long-standing polyposis. METHODS: Fifty-five patients with long-standing nasal polyposis were treated over a 26-week period with fluticasone propionate aqueous nasal spray 200 micrograms bid, beclomethasone dipropionate aqueous nasal spray 200 micrograms bid or placebo, administered intranasally in an aqueous spray in a double-blind, placebo-controlled parallel-group design at a single center. The primary efficacy endpoint was the physicians' assessment of symptoms and polyp score. Peak nasal inspiratory flow was performed twice daily and on every visit to evaluate the effect of the corticosteroids on nasal air flow. RESULTS: A significant difference in the primary efficacy endpoint between fluticasone propionate aqueous nasal spray and beclomethasone dipropionate aqueous nasal spray compared with placebo was seen after 14 weeks of treatment. This was further verified by the peak nasal inspiratory flow results. There was some evidence of earlier onset in the fluticasone propionate aqueous nasal spray group compared with the beclomethasone dipropionate aqueous nasal spray group after 4 weeks in terms of the primary efficacy endpoint. From the daily record cards patients receiving fluticasone propionate aqueous nasal spray had a significantly higher percentage of days on which they required no rescue medication (P < .009) and a higher percentage of days with an overall nasal blockage score on waking of < 2 (P < .013) when compared with placebo-treated patients. No other statistically significant results were found between the two active compounds. CONCLUSION: Fluticasone propionate aqueous nasal spray 200 micrograms bid and beclomethasone dipropionate aqueous nasal spray 200 micrograms bid are effective in treating the symptoms of nasal polyps, with some evidence that fluticasone propionate aqueous nasal spray has a faster onset of action and is tolerated at least as well as beclomethasone dipropionate aqueous nasal spray at the same dose.

Administration, Intranasal↗