Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis

Archives of Disease in Childhood

Volumn 77, Issue 2, 1997, Pages 124-130

  Balfour Lynn, Ian M ^a   Klein, Nigel J ^a   Dinwiddie, Robert ^a  

^a GREAT ORMOND STREET HOSPITAL   (United Kingdom)

Author keywords

Corticosteroids; Cystic fibrosis; Inflammation; Randomised controlled trial

Indexed keywords

CORTICOSTEROID; FLUTICASONE PROPIONATE; INTERLEUKIN 10; INTERLEUKIN 8; LEUKOCYTE ELASTASE; PLACEBO; TUMOR NECROSIS FACTOR ALPHA;

ADOLESCENT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; CYSTIC FIBROSIS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DRY POWDER; FORCED EXPIRATORY VOLUME; HUMAN; INHALATIONAL DRUG ADMINISTRATION; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SKIN ABRASION;

EID: 0030883124     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/adc.77.2.124     Document Type: Article

References (41)

1. Khan TZ, Wagener JS, Bost T, Martinez J, Accurso FJ, Riches DWH. Early pulmonary inflammation in infants with cystic fibrosis. Am J Respir Crit Care Med 1995;151:1075-82.
2. Armstrong DS, Grimwood K, Carzino R, Carlin JB, Olinsky A, Phelan PD. Lower respiratory tract infection and inflammation in infants with newly diagnosed cystic fibrosis. BMJ 1995;310:1571-2.
3. Konstan MW, Hilliard KA, Norvell TM, Berger M. Bronchoalveolar lavage findings in cystic fibrosis patients with stable, clinically mild lung disease suggest ongoing infection and inflammation. Am J Respir Crit Care Med 1994;150:448-54.
4. Balough K, McCubbins M, Weinberger M, Smits W, Ahrens R, Fick R. The relationship between infection and inflammation in the early stages of lung disease from cystic fibrosis. Pediatr Pulmonol 1995;20:63-70.
5. Cantin A. Cystic fibrosis lung inflammation: early, sustained and severe. Am J Respir Crit Care Med 1995;151:939-41.
6. Konstan MW, Byard PJ, Hoppel CL, Davis PB. Effect of high-dose ibuprofen in patients with cystic fibrosis. N Engl J Med 1995;332:848-54.
7. Sordelli DO, Macri CN, Maillie AJ, Cerquetti MC. A preliminary study on the effect of anti-inflammatory treatment in cystic fibrosis patients with Pseudomonas aeruginosa lung infection. Int J Immunopathol Pharmacol 1994;7: 109-17.
8. Aronoff SC, Quinn FJ, Carpenter LS, Novick WJ. Effects of pentoxifylline on sputum neutrophil elastase and pulmonary function in patients with cystic fibrosis: preliminary observations. J Pediatr 1994;125:992-7.
9. McElvaney NG, Nakamura H, Birer P, et al. Modulation of airway inflammation in cystic fibrosis. In vivo suppression of interleukin-8 levels on the respiratory epithelial surface by aerosolization of recombinant secretory leukoprotease inhibitor. J Clin Invest 1992;90:1296-301.
10. McElvaney NG, Hubbard RC, Birrer P, et al. Aerosol α1-antitrypsin treatment for cystic fibrosis. Lancet 1991; 337:392-4.
11. Balfour-Lynn IM, Dinwiddie R. Role of corticosteroids in cystic fibrosis lung disease. J R Soc Med 1996;89(suppl 27):8-13.
12. Auerbach HS, Williams M, Kirkpatrick JA, Cotten HR. Alternate day prednisolone reduces the morbidity and improves pulmonary function in cystic fibrosis. Lancet 1985;ii:686-8.
13. Donati MA, Haver K, Gerson W, Klein M, McLaughlin FJ, Wohl MEB. Long term alternate day prednisolone therapy in cystic fibrosis. Pediatr Pulmonol Suppl 1990;5:277.
14. Eigen H, Rosenstein BJ, FitzSimmons S, Schidlow DV, Cystic Fibrosis Foundation Prednisone Trial Group. A multicenter study of alternate-day prednisone therapy in patients with cystic fibrosis. J Pediatr 1995;126:515-23.
15. Russell G. Inhaled corticosteroid therapy in children: an assessment of the potential for side effects. Thorax 1994;49:1185-8.
16. Richman-Eisenstat JBY, Jorens PG, Hébert CA, Ueki I, Nadel JA. Interleukin-8: an important chemoattractant in sputum of patients with chronic inflammatory airway diseases. Am J Physiol 1993;264(Lung Cell Mol Physiol 8):L413-8.
17. 1-Proteinase inhibitor, elastase activity, and lung disease severity in cystic fibrosis. Am Rev Respir Dis 1993;148:1665-70.
18. Bonfield TL, Panuska JR, Konstan MW, et al. Inflammatory cytokines in cystic fibrosis lungs. Am J Respir Crit Care Med 1995;152:2111-8.
19. Bonfield TL, Konstan MW, Burfiend P, Panuska JR, Hilliard JB, Berger M. Normal bronchial epithelial cells constitutively produce the anti-inflammatory cytokine interleukin-10, which is downregulated in cystic fibrosis. Am J Respir Cell Mol Biol 1995;13:257-61.
20. Asher MI, Keil U, Anderson HR, et al. International study of asthma and allergies in childhood (ISAAC): rationale and methods. Eur Respir J 1995;8:483-91.
21. Greally P, Hussein MJ, Cook AJ, Sampson AP, Piper PJ, Price JF. Sputum rumour necrosis factor-α and leukotriene concentrations in cystic fibrosis. Arch Dis Child 1993;68: 389-92.
22. Finn A, Morgan P, Rebuck N, et al. Effects of inhibition of complement activation using recombinant soluble CR1 on neutrophil CD11b/CD 18 and L-selectin expression and release of IL8 and elastase in simulated cardiopulmonary bypass. J Thorac Cardiovasc Surg 1996;112:451-9.
23. Rosenthal M, Bain SH, Cramer D, et al. Lung function in white children aged 4 to 19 years: I - spirometry. Thorax 1993;48:794-802.
24. Koch GG. Use of non-parametric methods in the statistical analysis of the two-period change-over design. Biometrics 1972;28:577-84.
25. Cantin AM, Escher E. Protease inhibitors. Pediatr Pulmonol Suppl 1994;10:159-60.
26. Salva PS, Doyle NA, Graham L, Eigen H, Doerschuk CM. TNF-α, soluble ICAM-1, and neutrophils in sputum of cystic fibrosis patients. Pediatr Pulmonol 1996;21:11-9.
27. Richman-Eisenstat J. Cytokine soup: making sense of inflammation in cystic fibrosis. Pediatr Pulmonol 1996;21:3-5.
28. Dean TP, Shute JK, Briars G, Connett G, Church MK, Warner JO. Effect of antibiotic therapy in cystic fibrosis (CF) on sputum concentrations of inflammatory markers. Eur Respir J 1995;8 (suppl 19):511S.
29. Ramsey BW, Boat TF. Outcome measures for clinical trials in cystic fibrosis. Summary of a cystic fibrosis foundation consensus conference. J Pediatr 1994;124:177-92.
30. Dean TP, Dai YD, Shute JK, Church MK, Warner JO. Interleukin-8 concentrations are elevated in bronchoalveolar lavage, sputum, and sera of children with cystic fibrosis. Pediatr Res 1993;34:159-61.
31. Kronborg G, Hansen MB, Svenson M, Fomsgaard A, Høiby N, Bendtzen K. Cytokines in sputum and serum from patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection as markers of destructive inflammation in the lungs. Pediatr Pulmonol 1993;15:292-7.
32. Konstan MW, Berger M. Infection and inflammation of the lung in cystic fibrosis. In: Davis PB, ed. Cystic fibrosis. New York: Marcel Dekker Inc, 1993.
33. Adams DH, Lloyd AR. Chemokines: leucocyte recruitment and activation cytokines. Lancet 1997;349:490-5.
34. MacKenzie CA, Weinberg EG, Tabachnik E, Taylor M, Havnen J, Crescenzi K. A placebo controlled trial of fluticasone propionate in asthmatic children. Eur J Pediatr 1993;152:856-60.
35. Nickerson BG, Lemen RJ, Gerdes CB, Wegmann MJ, Robertson G. Within-subject variability and per cent change for significance for spirometry in normal subjects and in patients with cystic fibrosis. Am Rev Respir Dis 1980;122: 859-68.
36. Cooper PJ, Robertson CF, Hudson IL, Phelan PD. Variability of pulmonary function tests in cystic fibrosis. Pediatr Pulmonol 1990;8:16-22.
37. Van Haren EHJ, Lammers J-WJ, Festen J, Heijerman HGM, Groot CAR, van Herwaarden CLA. The effects of the inhaled corticosteroid budesonide on lung function and bronchial hyperresponsiveness in adult patients with cystic fibrosis. Respir Med 1995;89:209-14.
38. Nieman R, Williams S, Maden C, Knight R, Hodson M. A double-blind placebo-controlled study comparing the effects of the inhaled corticosteroid fluticasone propionate 500 mcg BID with placebo in adults with cystic fibrosis. Am J Respir Crit Care Med 1996;153:A72.
39. Greally P, Hussain MJ, Vergani D, Price JF. Interleukin-1α, soluble interleukin-2 receptor, and IgG concentrations in cystic fibrosis treated with prednisolone. Arch Dis Child 1994;71:35-9.
40. Schiøtz PO, Jørgensen M, Flensborg EW, et al. Chronic Pseudomonas aeruginosa lung infection in cystic fibrosis. Acta Paediatr Scand 1983;72:283-7.
41. Nikolaizik WH, Schöni MH. Pilot study to assess the effect of inhaled corticosteroids on lung function in patients with cystic fibrosis. J Pediatr 1996;128:271-4.