Evaluation of efficacy and safety of flunisolide hydrofluoroalkane for the treatment of asthma

Clinical Therapeutics

Volumn 25, Issue 3, 2003, Pages 776-798

  Corren, Jonathan ^a   Tashkin, Donald P ^b  

^a Allergy Research Foundation   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Asthma; Chlorofluorocarbon; Flunisolide hydrofluoroalkane

Indexed keywords

BECLOMETASONE; BUDESONIDE; CHLOROFLUOROCARBON; FLUNISOLIDE; FLUORINATED HYDROCARBON; FLUTICASONE; PROPELLANT; SALBUTAMOL; TRIAMCINOLONE ACETONIDE;

ADOLESCENT; ADULT; AEROSOL; AIRWAY; ASTHMA; CANDIDIASIS; CHILD; CLINICAL TRIAL; DOSE RESPONSE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; GROWTH RETARDATION; HUMAN; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; LUNG FUNCTION; METERED DOSE INHALER; OROPHARYNX; PARTICLE SIZE; REVIEW; RISK BENEFIT ANALYSIS; SYMPTOMATOLOGY;

EID: 0037363488     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(03)80108-X     Document Type: Review

References (71)

1. National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. Bethesda, Md: National Heart, Lung, and Blood Institute, National Institutes of Health; 1997. Publication no. 97-4051.
2. National Asthma Education and Prevention Program. Expert Panel report: Guidelines for the diagnosis and management of asthma update on selected topics - 2002. J Allergy Clin Immunol. 2002;110(Suppl):S141-S219.
3. in't Veen JC, Beekman AJ, Bel EH, Sterk PJ. Recurrent exacerbations in severe asthma are associated with enhanced airway closure during stable episodes. Am J Respir Crit Care Med. 2000;161:1902-1906.
4. Kraft M, Djukanovic R, Wilson S, et al. Alveolar tissue inflammation in asthma. Am J Respir Crit Care Med. 1996;154:1505-1510.
5. Consensus Conference on Aerosols and Delivery Devices. September 24-26, 1999, Bermuda. Respir Care. 2000;45:586-768.
6. Grossman J. The evolution of inhaler technology. J Asthma. 1994;31:55-64.
7. Donnell D, Harrison LI, Ward S, et al. Acute safety of the CFC-free propellant HFA-134a from a pressurized metered dose inhaler. Eur J Clin Pharmacol. 1995;48:473-477.
8. Leach CL. Improved delivery of inhaled steroids to the large and small airways. Respir Med. 1998;92(Suppl A):3-8.
9. Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002;109(Suppl):S447-S460.
10. Toogood JH, Baskerville J, Jennings B, et al. Use of spacers to facilitate inhaled corticosteroid treatment of asthma. Am Rev Respir Dis. 1984;129:723-729.
11. Kamps AW, van Ewijk B, Roorda RJ, Brand PL. Poor inhalation technique, even after inhalation instructions, in children with asthma. Pediatr Pulmonol. 2000;29:39-42.
12. Azzawi M, Bradley B, Jeffery PK, et al. Identification of activated T lymphocytes and eosinophils in bronchial biopsies in stable atopic asthma. Am Rev Respir Dis. 1990;142:1407-1413.
13. Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998;12:1346-1353.
14. Beasley R, Roche WR, Roberts JA, Holgate ST. Cellular events in the bronchi in mild asthma and after bronchial provocation. Am Rev Respir Dis. 1989;139:806-817.
15. Sobonya RE. Quantitative structural alterations in long-standing allergic asthma. Am Rev Respir Dis. 1984;130:289-292.
16. Carroll N, Elliot J, Morton A, James A. The structure of large and small airways in nonfatal and fatal asthma. Am Rev Respir Dis. 1993;147:405-410.
17. Kraft M. The distal airways: Are they important in asthma? Eur Respir J. 1999;14:1403-1417.
18. Goldin JG, McNitt-Gray MF, Sorenson SM, et al. Airway hyperreactivity: Assessment with helical thin-section CT. Radiology. 1998;208:321-329.
19. Hamid Q, Song Y, Kotsimbos TC, et al. Inflammation of small airways in asthma. J Allergy Clin Immunol. 1997;100:44-51.
20. Saetta M, Di Stefano A, Rosina C, et al. Quantitative structural analysis of peripheral airways and arteries in sudden fatal asthma. Am Rev Respir Dis. 1991;143:138-143.
21. Hogg JC, Macklem PT, Thurlbeck WM. Site and nature of airway obstruction in chronic obstructive lung disease. N Engl J Med. 1968;278:1355-1360.
22. Wagner EM, Liu MC, Weinmann GG, et al. Peripheral lung resistance in normal and asthmatic subjects. Am Rev Respir Dis. 1990;141:584-588.
23. McFadden ER Jr, Linden DA. A reduction in maximum mid-expiratory flow rate. A spirographic manifestation of small airway disease. Am J Med. 1972;52:725-737.
24. Klein RB, Fritz GK, Yeung A, et al. Spirometric patterns in childhood asthma: Peak flow compared with other indices. Pediatr Pulmonol. 1995;20:372-379.
25. Lebecque P, Kiakulanda P, Coates AL. Spirometry in the asthmatic child: Is FEF25-75 a more sensitive test than FEV1/FVC? Pediatr Pulmonol. 1993;16:19-22.
26. Tulic MK, Christodoulopoulos P, Hamid Q. Small airway inflammation in asthma. Respir Res. 2001;2:333-339.
27. Weibel ER. Geometry and dimensions of airways conductive and transitory zones. In: Morphometry of the Human Lung. Berlin, Germany: Springer; 1963:110-135.
28. Wiggs BR, Bosken C, Pare PD, et al. A model of airway narrowing in asthma and in chronic obstructive pulmonary disease. Am Rev Respir Dis. 1992;145:1251-1258.
29. Wagner EM, Bleecker ER, Permutt S, Liu MC. Direct assessment of small airways reactivity in human subjects. Am J Respir Crit Care Med. 1998;157:447-452.
30. Haley KJ, Sunday ME, Wiggs BR, et al. Inflammatory cell distribution within and along asthmatic airways. Am J Respir Crit Care Med. 1998;158:565-572.
31. Goldin JG, Tashkin DP, Kleerup EC, et al. Comparative effects of hydrofluoroalkane and chlorofluorocarbon beclomethasone dipropionate inhalation on small airways: Assessment with functional helical thin-section computed tomography. J Allergy Clin Immunol. 1999;104:S258-S267.
32. Tashkin DP, Goldin JG, Kleerup EC. Evaluation of small airways and the impact of inhaled steroids - size does matter. In: Peters SP, Wenzel SE, eds. Asthma and Small Airways. New York: American Thoracic Society; 2000:7-15.
33. Cosio M, Ghezzo H, Hogg JC, et al. The relations between structural changes in small airways and pulmonary-function tests. N Engl J Med. 1978;298:1277-1281.
34. van Essen-Zandvliet EE, Hughes MD, Waalkens HJ, et al. Effects of 22 months of treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. The Dutch Chronic Non-specific Lung Disease Study Group. Am Rev Respir Dis. 1992;146:547-554.
35. Bisgaard H, Moller H. Changes in risk of hospital readmission among asthmatic children in Denmark, 1978-93. BMJ. 1999;319:229-230.
36. Laitinen LA, Laitinen A. Mucosal inflammation and bronchial hyperreactivity. Eur Respir J. 1988;1:488-489.
37. International Consensus Report on the diagnosis and management of rhinitis. International Rhinitis Management Working Group. Allergy. 1994;49(Suppl):1-34.
38. Barnes PJ. Inhaled glucocorticoids for asthma. N Engl J Med. 1995;332:868-875.
39. Barnes PJ, Pedersen S, Busse WW. Efficacy and safety of inhaled corticosteroids. New developments. Am J Respir Crit Care Med. 1998:157:S1-S53.
40. Leach C. Effect of formulation parameters on hydrofluoroalkane-beclomethasone dipropionate drug deposition in humans. J Allergy Clin Immunol. 1999;104:S250-S252.
41. Esmailpour N, Hogger P, Rabe KF, et al. Distribution of inhaled fluticasone propionate between human lung tissue and serum in vivo. Eur Respir J. 1997;10:1496-1499.
42. Kennedy WA, Laurier C, Gautrin D, et al. Occurrence and risk factors of oral candidiasis treated with oral antifungals in seniors using inhaled steroids. J Clin Epidemiol. 2000;53:696-701.
43. Toogood JH, Lefcoe NM, Haines DS, et al. A graded dose assessment of the efficacy of beclomethasone dipropionate aerosol for severe chronic asthma. J Allergy Clin Immunol. 1977;59:298-308.
44. Malo JL, Cartier A, Ghezzo H, et al. Comparison of four-times-a-day and twice-a-day dosing regimens in subjects requiring 1200 micrograms or less of budesonide to control mild to moderate asthma. Respir Med. 1995;89:537-543.
45. Smith MJ, Hodson ME. High-dose beclomethasone inhaler in the treatment of asthma. Lancet. 1983;1:265-269.
46. Gabrio BJ, Stein SW, Velasquez DJ. A new method to evaluate plume characteristics of hydrofluoroalkane and chlorofluorocarbon metered dose inhalers. Int J Pharm. 1999;186:3-12.
47. Newman SP, Steed KP, Hooper G, et al. Improved targeting of beclomethasone dipropionate (250 micrograms metered dose inhaler) to the lungs of asthmatics with the Spacehaler. Respir Med. 1999;93:424-431.
48. Dolovich MA. Influence of inspiratory flow rate, particle size, and airway caliber on aerosolized drug delivery to the lung. Respir Care. 2000;45:597-608.
49. Bates DV, Fish BR, Hatch TF, et al. Deposition and retention models for internal dosimetry of the human respiratory tract. Task group on lung dynamics. Health Phys. 1966;12:173-207.
50. Howarth PH. Small airways and asthma. An important therapeutic target? Am J Respir Crit Care Med. 1998;157:S173.
51. Lange P, Parner J, Vestbo J, et al. A 15-year follow-up study of ventilatory function in adults with asthma. N Engl J Med. 1998;339:1194-1200.
52. Almind M, Viskum K, Evald T, et al. A seven-year follow-up study of 343 adults with bronchial asthma. Dan Med Bull. 1992;39:561-565.
53. Emmen HH, Hoogendijk EM, Klopping-Ketelaars WA, et al. Human safety and pharmacokinetics of the CFC alternative propellants HFC 134a (1,1,1,2-tetrafluoroethane) and HFC 227 (1,1,1,2,3,3, 3-heptafluoropropane) following whole-body exposure. Regal Toxicol Pharmacol. 2000;32:22-35.
54. Newman SP. Aerosol physiology, deposition, and metered dose inhalers. Allergy Proc. 1991;12:41-45.
55. Richards J, Hirst P, Pitcairn G, et al. Deposition and pharmacokinetics of flunisolide delivered from pressurized inhalers containing non-CFC and CFC propellants. J Aerosol Med. 2001;14:197-208.
56. Newman SP, Clark DA, Kalirai CS, et al. Lung deposition and distribution of flunisolide-HFA, assessed by gamma scintigraphy and single photon emission computed tomography (SPECT). J Allergy Clin Immunol. 2003;111:S216. Abstract 591.
57. Carroll N, Cooke C, James A. The distribution of eosinophils and lymphocytes in the large and small airways of asthmatics. Eur Respir J. 1997;10:292-300.
58. Corren J, Nelson H, Greos L, et al. Effective control of asthma with hydrofluoroalkane flunisolide delivered as an extrafine aerosol in asthma patients. Ann Allergy Asthma Immunol. 2001;87:405-411
59. Bensch G, Newman K. Flunisolide HFA at one third the dose of flunisolide CFC: Equivalent efficacy in patients with asthma. Poster presented at: 3rd Triennial World Asthma Meeting; July 13-15, 2001; Chicago, Ill.
60. Meadows AJ, Milgrom H, Walcott DW. Safety and efficacy of flunisolide HFA vs flunisolide CFC in children with asthma. Paper presented at: 3rd Triennial World Asthma Meeting; July 13-15, 2001; Chicago, Ill.
61. Nolting A, Abramowitz W. Multiple-dose proportionality study of flunisolide hydro-fluoroalkane. Allergy Asthma Proc. 2002;23:311-318.
62. Nolting A, Sista S, Abramowitz W. Single-dose study to compare the pharmacokinetics of HFA flunisolide and CFC flunisolide. J Pharm Sci. 2002;91:424-432.
63. Nolting A, Sista S, Abramowitz W. Flunisolide HFA vs flunisolide CFC: Pharmacokinetic comparison in healthy volunteers. Biopharm Drug Dispos 2001;22:373-382.
64. Leflein J, Goldstein M. Flunisolide HFA has no significant effects on HPA axis function vs beclomethasone dipropionate in patients with asthma. Paper presented at: 3rd Triennial World Asthma Meeting; July 13-15, 2001; Chicago, Ill.
65. Casale TB, Nelson HS, Corren J, Newman K. Long-term safety of flunisolide hydro-fluoroalkane metered-dose inhaler in adults and adolescents with asthma. Clin Drug Invest. 2001;21:755-764.
66. Boguniewicz M, Gillman S. Flunisolide HFA has no effect on growth in children with asthma. Poster presented at: 3rd Triennial World Asthma Meeting; July 13-15, 2001; Chicago, Ill.
67. Hochhaus G, Moellmann HW. Binding affinities of rimexolone (ORG 6216), flunisolide and their putative metabolites for the glucocorticoid receptor of human synovial tissue. Agents Actions 1990;30:377-380.
68. Sharek PJ, Bergman DA. The effect of inhaled steroids on the linear growth of children with asthma: A meta-analysis. Pediatrics. 2000;106:E8.
69. Wolthers OD, Pedersen S. Growth of asthmatic children during treatment with budesonide: A double blind trial. BMJ. 1991;303:163-165.
70. Hollman GA, Allen DB. Overt glucocorticoid excess due to inhaled corticosteroid therapy. Pediatrics. 1988;81:452-455.
71. Tanner JM, Davies PS. Clinical longitudinal standards for height and height velocity for North American children. J Pediatr. 1985;107:317-329.