Assessment of adrenal suppression from two new dry powder inhaler formulations of budesonide delivered by Clickhaler® compared with the Pulmicort® Turbuhaler®

Journal of Aerosol Medicine: Deposition, Clearance, and Effects in the Lung

Volumn 16, Issue 1, 2003, Pages 31-36

  Kirkpatrick, C ^a   Buck, H ^b   Ellis, S ^b   Baines, Laura ^c  

^a Chiltern International Ltd   (United Kingdom)

^b Innovata Biomed Ltd   (United Kingdom)

^c Blaby Hall ^*  (United Kingdom)

Author keywords

Adrenal suppression; Budesonide; Hypothalamic pituitary adrenal axis; Inhaled corticosteroids

Indexed keywords

BUDESONIDE; CORTICOSTEROID; PASSCAL; PLACEBO;

ADRENAL DISEASE; ADRENAL SUPPRESSION; ADULT; ARTICLE; BLOOD ANALYSIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; FEMALE; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE URINE LEVEL; HYPOTHALAMUS HYPOPHYSIS SYSTEM; INTERMETHOD COMPARISON; MALE; NEBULIZATION; NORMAL HUMAN; POWDER INHALER; RADIOIMMUNOASSAY; SIDE EFFECT; STATISTICAL SIGNIFICANCE; URINALYSIS;

ADRENAL GLANDS; ANTI-INFLAMMATORY AGENTS; BIOLOGICAL AVAILABILITY; BUDESONIDE; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; HUMANS; HYDROCORTISONE; RADIOIMMUNOASSAY;

EID: 0037263661     PISSN: 08942684     EISSN: None     Source Type: Journal    
DOI: 10.1089/089426803764928338     Document Type: Article

References (15)

1. Ryrfeldt, A., P. Anderson, S. Edsbäcker, et al. 1982. Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur. J. Respir. Dis. 122:86-95.
2. Johansson, S.-A., K.-E. Andersson, R. Brattsand, et al. 1982. Topical and systemic glucocorticoid potencies of budesonide, beclomethasone dipropionate and prednisolone in man. Eur. J. Respir. Dis. 63:74-82.
3. Lipworth, B.J., and J.R. Seckl. 1997. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 52:476-482.
4. Godfrey, C., Buck, H., and Ellis, S. 2002. Bioavailability of budesonide delivered by the Clickhaler® and Turbohaler® dry powder inhalers in healthy volunteers. A pilot study. Clin. Drug Invest. 22:119-124.
5. Warren, S., Taylor, G., Smith, J., et al. 2002. Gamma scintigraphic evaluation of a novel budesonide dry powder inhaler using a validated radio labelling technique. J. Aerosol Med. 15:15-25.
6. Clark, D.J., A.M. Grove, R.I. Cargill, et al. 1996. Comparative adrenal suppression with inhaled budesonide and fluticasone propionate in adult asthmatic patients. Thorax 51:262-266.
7. Brown, P.H., S.P. Matusiewicz, C. Shearing, et al. 1993. Systemic effects of high dose inhaled steroids on beclomethasone dipropionate and budesonide in healthy subjects. Thorax 48:967-973.
8. Parry-Billings, M., R.N. Boyes, L.M. Clisby, et al. 1999. Design, development, and performance of a novel multidose dry-powder inhaler. Pharm. Technol. 23:70-81.
9. Staniforth, J.N. 1996. Pre-formulation aspects of dry powder aerosols. In R.N. Dalby, P.R. Byron, and S.J. Farr, eds. Proceedings of Respiratory Drug Delivery V. Interpharm Press, Buffalo Grove, IL, 6.
10. Holt, P.R., D.W. Lowndes, E. Smithies, et al. 1990. The effect of an inhaled steroid on the hypothalamic-pituitary-adrenal axis - which tests should be used? Clin. Exp. Allergy 20:145-149.
11. Brutsche, M., Brutsche, I., Munawar, M., et al. 2000. Comparison of pharmacokinetics and systemic effects of inhaled fluticasone propionate in patients with asthma and healthy volunteers: a randomised crossover study. Lancet 356:556-561.
12. Clark, D.J., A. Grove, R.I. Cargill, et al. 1996. Comparative adrenal suppression with inhaled budesonide and fluticasone propionate in adult asthmatic patients. Thorax 51:262-266.
13. Thorsson, L., S. Edsbäcker, and T.-B. Conradson. 1994. Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI. Eur. Respir. J. 7:1839-1844.
14. Wong, B.J.O., and F.E. Hargreave. 1993. Bioequivalence of metered-dose inhaled medications. J. Allergy Clin. Immunol. 92:373-379.
15. Pedersen, S., G. Steffensen, and S.V. Ohlsson. 1993. The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler. Br. J. Clin. Pharmac. 36:211-214.