Comparative assessment of safety and efficacy of inhaled corticosteroids: report of a committee of the Canadian Thoracic Society

Lp, Boulet; Cockcroft, D. W.; Toogood, J.H.; Lacasse, Yves; Baskerville, J.; Fe, Hargreave

doi:10.1183/09031936.98.11051194

Cited by 24 publications

(17 citation statements)

References 133 publications

(146 reference statements)

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“…Despite this marked difference in systemic availability, the two groups did not differ in plasma cortisol suppression during a 12 h dosing interval. A confounding factor in asthmatic patients is that the HPA-axis function may be affected by previous treatment with oral or inhaled corticosteroids, which makes it dif®cult to compare the cortisol suppression relative to baseline values between healthy and asthmatic subjects [12]. The present study indicates that the majority of asthmatic patients, i.e.…”

Section: Regimenmentioning

confidence: 67%

See 1 more Smart Citation

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®

Thorsson

Edsbäcker

Källén

et al. 2001

Brit J Clinical Pharma

156

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Aims To determine the basal pharmacokinetics, lung uptake and plasma cortisol suppression for two commonly prescribed inhaled corticosteroids. Methods Twenty-one subjects (13 healthy and 8 mild asthmatic patients) received uticasone propionate via a chloro¯uorocarbon-propelled pressurized metered-dose inhaler (pMDI) (healthy subjects only) and Diskus 1 and budesonide via Turbuhaler 1 , 1000 mg twice daily for 7 days. Intravenous doses (200 mg) of both compounds were used as references. Plasma concentrations of¯uticasone and budesonide were determined during 48 h by liquid chromatography plus tandem mass spectrometry (LC-MS-MS). Plasma concentrations of cortisol were determined by LC-MS every second hour for 24 h at baseline, and following each treatment. Results The volume of distribution was found to be larger and the elimination half-life and mean absorption time longer for¯uticasone than for budesonide. The systemic availability of budesonide via Turbuhaler (39%) was signi®cantly higher than that of uticasone via Diskus (13%) (ratio 3.0 [2.5, 3.6] with 95% con®dence interval [CI]), and via pMDI (21%) (ratio 1.8 [1.3, 2.3]). In addition, at steady state the systemic availability of¯uticasone via pMDI was signi®cantly higher than via Diskus (ratio 1.6 [1.1, 2.2]). The lung deposition of budesonide via Turbuhaler was 2.2-fold [1.7, 2.9] higher than that of¯uticasone pMDI and 3.4-fold [2.8, 4.0] higher than that of uticasone Diskus. In addition, the lung deposition of¯uticasone via pMDI was 1.5-fold [1.1, 2.9] higher than that via the Diskus inhaler. Plasma cortisol (24 h) was signi®cantly reduced vs baseline for all three treatments. The cortisol concentration vs baseline was 12% for¯uticasone pMDI, which was signi®cantly lower (ratio 0.32 [0.24, 0.42]) than that for¯uticasone Diskus (39%), and for budesonide Turbuhaler (46%) (ratio 0.27 [0.21, 0.37]). The plasma cortisol concentration did not differ signi®cantly between treatments with¯uticasone Diskus and budesonide Turbuhaler (ratio 0.87 [0.65; 1.15]). Conclusions Budesonide and¯uticasone differ in their pharmacokinetic properties in that although clearance is the same, the rate of uptake and elimination is slower for uticasone. Despite a signi®cantly higher pulmonary availability of budesonide via Turbuhaler, the plasma cortisol suppression is less than that of¯uticasone via pMDI and similar to that of¯uticasone via Diskus. There is no indication of any difference between healthy subjects and mild asthmatic patients in the pharmacokinetics and plasma cortisol suppression of¯uticasone and budesonide.

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Section: Regimenmentioning

confidence: 67%

“…One reason for this is to minimize the between-subject variability [12]. Recently, a correlation between asthma severity and cortisol suppression was shown for¯uticasone [13], although for budesonide, such a relationship is much less clear [14].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®

Thorsson

Edsbäcker

Källén

et al. 2001

Brit J Clinical Pharma

156

View full text Add to dashboard Cite

show abstract

“…16,17 Demonstration of a dose-response relationship is necessary to select the appropriate doses for comparison of clinical efficacies of different ICS preparations or the same ICS delivered by different devices. 18,19 The sample size required can be calculated by using an estimate of the slope and variability of the dose-response relationship. It is hypothesized that the beneficial clinical effects of ICS are related, at least in part, to the attenuation of airway inflammation, 20 and this can be assessed conveniently and relatively noninvasively by measurements of sputum cell counts.…”

mentioning

confidence: 99%

Eosinophilic bronchitis in asthma: A model for establishing dose-response and relative potency of inhaled corticosteroids

Kelly

Leigh

Jayaram

et al. 2006

Journal of Allergy and Clinical Immunology

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“…Although most asthmatic patients require low to medium doses of ICSs, some may require high doses, either for periods of exacerbation or for prolonged periods of time (1,2,15). ICSs may be associated with dose-related systemic adverse events, such as HPA axis suppression, ocular events and ecchymosis (16).…”

Section: Discussionmentioning

confidence: 99%

“…CONCLUSIONS : Le DB-HFC administré à raison de 800 g/jour présente un tableau d'effets indésirables généraux, comparable à celui du DB-CFC administré à raison de 1500 g/jour; de plus, le passage du DB-CFC au DB-HFC aux doses indiquées ci-dessus peut améliorer la maîtrise des symptômes d'asthme. I nhaled corticosteroids (ICSs) have been used effectively for many years in the long term treatment of asthma and are considered by recent therapeutic guidelines to be the mainstay of asthma therapy (1,2). Hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extra-fine aerosol (QVAR, 3M Pharmaceuticals, Canada) is a new formulation of BDP.…”

unclassified

Safety and Efficacy of HFA‐134a Beclomethasone Dipropionate Extra‐Fine Aerosol over Six Months

Boulet

Cartier

Ernst

et al. 2004

Canadian Respiratory Journal

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OBJECTIVE: To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate (HFA-BDP) extra-fine aerosol 800 µg/day with chlorofluorocarbon (CFC)-BDP 1500 µg/day.DESIGN: Six-month, randomized, parallel-group, double-blind, double-dummy study.PATIENTS: Patients (n=141) with moderate to severe asthma adequately controlled by CFC-BDP 1000 µg/day to 2000 µg/day.INTERVENTIONS: Patients received CFC-BDP 1500 µg/day during a two-week run-in period and were then randomized to either HFA-BDP (n=70) or CFC-BDP (n=71).RESULTS: Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 (15% versus 25%, P=0.35). Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP (P=0.076); 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients (P=0.095).CONCLUSIONS: HFA-BDP 800 µg/day has a systemic adverse event profile comparable to that of CFC-BDP 1500 µg/day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 µg/day to HFA-BDP 800 µg/day.

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Comparative assessment of safety and efficacy of inhaled corticosteroids: report of a committee of the Canadian Thoracic Society

Cited by 24 publications

References 133 publications

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®

Eosinophilic bronchitis in asthma: A model for establishing dose-response and relative potency of inhaled corticosteroids

Safety and Efficacy of HFA‐134a Beclomethasone Dipropionate Extra‐Fine Aerosol over Six Months

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Comparative assessment of safety and efficacy of inhaled corticosteroids: report of a committee of the Canadian Thoracic Society

Cited by 24 publications

References 133 publications

Pharmacokinetics and systemic activity of fluticasone via Diskus® and pMDI, and of budesonide via Turbuhaler®

Pharmacokinetics and systemic activity of fluticasone via Diskus® and pMDI, and of budesonide via Turbuhaler®

Eosinophilic bronchitis in asthma: A model for establishing dose-response and relative potency of inhaled corticosteroids

Safety and Efficacy of HFA‐134a Beclomethasone Dipropionate Extra‐Fine Aerosol over Six Months

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Product

Resources

About

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®

Pharmacokinetics and systemic activity of fluticasone via Diskus^® and pMDI, and of budesonide via Turbuhaler^®