Safety and efficacy of a new albuterol hydrofluoroalkane formulation for treating asthma symptoms in children two to less than four years of age

Pediatric Asthma, Allergy and Immunology

Volumn 19, Issue 2, 2006, Pages 81-90

  Kerwin, E M ^a   Tarpay, M M ^b   Kim, K ^c   Noonan, M J ^d   Lincourt, W ^e   Trivedi, R ^e   Ellsworth, A ^e   Davis, A M ^e  

^a Clinical Research Institute of Southern Oregon   (United States)

^b Allergy Asthma and Clinical Research Center   (United States)

^c West Coast Clinical Trials LLC   (United States)

^d Allergy Associates Research Center   (United States)

^e GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHLOROFLUOROCARBON; CORTICOSTEROID; CROMOGLYCATE DISODIUM; FLUORINATED HYDROCARBON; NEDOCROMIL; PLACEBO; SALBUTAMOL;

AROUSAL; ARTICLE; ASTHMA; CHILDHOOD DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FACE MASK; FEMALE; FEVER; GLUCOSE BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MULTICENTER STUDY; PEAK EXPIRATORY FLOW; POTASSIUM BLOOD LEVEL; PRESCHOOL CHILD; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SYMPTOM; TACHYCARDIA; TREMOR; VOMITING;

EID: 33745714842     PISSN: 08831874     EISSN: None     Source Type: Journal    
DOI: 10.1089/pai.2006.19.81     Document Type: Article

References (33)

1. Mannino DM, Homa DM, Pertowski CA, Ashizawa A, Nixon LL, Johnson CA, Ball LB, Jack F, Kang DS. Surveillance for asthma: United States, 1960-1995. Mor Mortal Wkly Rep CDC Surveill Summ 1998; 47:1-27.
2. Dey AN, Bloom B. Summary health statistics for US Children: National Health Interview Survey, 2003. National Center for Health Statistics. Vital Health Stat 2005; Mar(223):1-78.
3. 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; 1997. NIH Publication No. 97-4051.
4. Salathe M. Effects of β-agonists on airway epithelial cells. J Allergy Clin Immunol 2002; 110:S275-S281.
5. Panettieri RA. Airway smooth muscle: An immunomodulatory cell. J Allergy Clin Immunol 2002; 110:S269-S274.
6. Bennett WD. Effect of β-adrenergic agonists on mucociliary clearance. J Allergy Clin Immunol. 2002; 110:S291-S297.
7. National Asthma Education and Prevention Program (NAEPP). Executive Summary of the NAEPP Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma-Update on Selected Topics 2002. National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). June 2002.
8. Workshop Report: Global Strategy for Asthma Management and Prevention. NIH Publication No. 02-3659. Issued January 1995. Updated October 2004. www.ginasthma.com/GuidelineList.asp (Last accessed March 23, 2005).
9. American Academy of Allergy Asthma and Immunology, American Academy of Pediatrics, National Asthma Education and Prevention Program, National Heart, Lung and Blood Institute. Psdiatrix asthma: Promoting best practice. Guide for managing asthma in children, 1999.
10. Delgado A, Chou KJ, Silver EJ, Crain EF. Nebulizers vs. metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 months in a pediatric emergency department. Arch Pediatr Adolesc Med 2003; 157:76-80.
11. Castro-Rodriguez JA, Rodrigo GJ. β-agonists through metered-dose inhaler with valved holding chamber versus nebulizer for acute exacerbation of wheezing or asthma in children under 5 years of age: A systematic review with meta-analysis. J Pediatr 2004; 145:172-177.
12. Leversha AM, Campanella SG, Aickin RP, Asher MI. Costs and effectiveness of spacer versus nebulizer in young children with moderate and severe acute asthma. J Pediatr 2000; 136:497-502.
13. United Nations Environmental Programme (Ozone Secretariat). Handbook for the international treaties for the protection of the ozone layer, 4th ed. Kenya: 1996.
14. Stein RE, Jessop DJ. Functional Status II (R): A measure of child health status. Med Care 1990; 28:1041-1055.
15. Moss AJ. Measurement of the QT interval and the risk associated with QTc interval prolongation: a review. Am J Cardiol 1993; 72:23B-25B.
16. Lumry W, Noveck R, Weinstein S, Barnhart F, Vandermeer A, Murray A, Reisner C. Switching from Ventolin CFC to Ventolin HFA is well tolerated and effective in patients with asthma. Ann Allergy Asthma Immunol 2001; 86:297-303.
17. Shapiro G, Bronsky E, Murray A, Barnhart F, VanderMeer A, Reisner C. Clinical comparability of Ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthma. Arch Pediatr Adolesc Med 2000; 154:1219-1225.
18. Newman SP, Clarke SW. Therapeutic aerosols-Physical and practical considerations. Thorax 1983; 38:881-886.
19. Canny GJ, Levison HH. Aerosols: Therapeutic use and delivery in childhood asthma. Ann Allergy 1988; 60:11-20.
20. Turner MO, Gafni A, Swan D, Fitzgerald JM. A review and economic evaluation of bronchodilator delivery methods in hospitalized patients. Arch Intern Med 1996; 156:2113-2118.
21. Barnes KL, Clifford R, Holgate ST, Murphy D, Comber P, Bell E. Bacterial contamination of home nebulizers. Br Med J 1987; 295:812.
22. Ploin D, Chapuis FR, Stamm D, Robert J, David L, Chatelain PG, Dutau G, Floret D. High-dose albuterol by metered-dose inhaler plus a spacer device versus nebulization in preschool children with recurrent wheezing: A double-blind, randomized equivalence trial. Pediatrics 2000; 106:311-317.
23. Chou KJ, Cunningham SJ, Grain EF. Metered-dose inhalers with spacers vs. nebulizers for pediatric asthma. Arch Pediatr Adolesc Med 1995; 149:201-205.
24. Clark DJ, Lipworth BJ. Dose-response of inhaled drugs in asthma. Clin Pharmacokin 1997; 32:58-74.
25. Tandon MK. Cardiopulmonary effects of fenoterol and salbutamol aerosols. Chest 1980; 77:429-431.
26. Wong CS, Pavord ID, Williams J, Britton JR, Tattersfield AE. Bronchodilator, cardiovascular and hypokalemic effects of fenoterol, salbutamol and terbutaline in asthma. Lancet 1990; 336:1396-1399.
27. Bremner P, Woodman K, Burgess C, Crane J, Purdic G, Pearce N, Beasley R. A comparison of the cardiovascular and metabolic effects of formoterol, salbutamol and fenoterol. Eur Respir J 1993; 6:204-210.
28. Lipworth BJ, McDevitt DG. Beta-adrenoceptor responses to inhaled salbutamol in normal subjects. Eur J Clin Pharmacol 1989; 36:239-245.
29. Lipworth BJ, Clark RA, Dhillon DP, Brown RA, McDevitt DG. β-adrenoceptor responses to high doses of inhaled salbutamol in patients with bronchial asthma. Br J Clin Pharmacol 1988; 26:527-533.
30. Lipworth BJ, Struthers AD, McDevitt DG. Tachyphylaxis to systemic but not to airway responses during prolonged therapy with the high dose inhaled salbutamol in asthmatics. Am Rev Respir Dis 1989; 140:586-592.
31. Taylor DR, Wilkins GT, Herbison GP, Flannery EM. Interaction between corticosteroid and beta-agonist drugs. Biochemical and cardiovascular effects in normal subjects. Chest 1992; 102:519-524.
32. Newhouse MT, Chapman KR, McCallum AL, Abboud RT, Bowie DM, Hodder RV, Pare PD, Mesic-Fuchs H, Molfino NA. Cardiovascular safety of high doses of inhaled fenoterol and albuterol in acute severe asthma. Chest 1996; 110:595-603.
33. Coskun S, Yuksel H, Tikiz H, Danahaliloglu S. Standard dose of inhaled albuterol significantly increases QT dispersion compared to low dose of albuterol plus ipratropium bromide therapy in moderate to severe acute asthma attacks in children. Pediatr Int 2001; 43:631-636.