Clinical comparability between the CFC and HFA budesonide pressurised metered-dose inhalers in paediatric patients with asthma: a randomised controlled trial

References

• Global Initiative for Asthma: Global strategy for asthma management and prevention. GINA workshop report. Bethesda, MD: National Institutes for Health. NIH Publication No. 02–3659, 1995 (updated 2004)
   Google Scholar
• National Heart, Lung, and Blood Institute, National Institutes of Health. World Health Organization. Global initiative for asthma. Pocket guide for asthma management. Bethesda: NH/ NHLBI, 1998. Publication No. 96–3659B
   Google Scholar
• National Asthma Education Prevention Program (NAEPP) . Expert panel report: guidelines for the diagnosis and management of asthma – update on selected topics. J Allergy Clin Immunol 2002;110:S141–219
   Google Scholar
• Cripps A, Riebe M, Schulze M, et al. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med 2000;94 (Suppl B):S3–9
   Google Scholar
• Mueller-Walz R, Gilchrist P, Neiderlaender C. In-vitro characterization of SkyePharma budesonide HFA metered dose inhaler. J Aerosol Med 2003;16:193 [abstract 25]
   Google Scholar
• SkyePharma. Budesonide HFA metered dose inhaler. Data on file
   Google Scholar
• Masoli M, Wetherall M, Holt S, et al. Budesonide once versus twice-daily administration: meta-analysis. Respirology 2004;9:528–34
   PubMed Web of Science ®Google Scholar
• Selroos O, Edsbäcker S, Hultquist C. Once-daily inhaled budesonide for the treatment of asthma: clinical evidence and pharmacokinetic explanation. J Asthma 2004;41:771–90
   PubMed Web of Science ®Google Scholar
• Sheffer AL, Silverman M, Woolcock AJ, et al. Long-term safety of once-daily budesonide in patients with early onset mild persistent asthma: results of the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study. Ann Allergy Asthma Immunol 2005;94:48–54
   PubMed Web of Science ®Google Scholar
• Szefler SJ, Lyzell E, Fitzpatrick S, et al. Safety profile of budesonide inhalation suspension in the pediatric population: worldwide experience. Ann Allergy Asthma Immunol 2004;93:83–90
   PubMed Web of Science ®Google Scholar
• Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med 1994;88:373–81
   PubMed Web of Science ®Google Scholar
• Haahtela T, Järvinen M, Kava T, et al. Comparison of a beta2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma. New Engl J Med 1991;325:388–92
   PubMed Web of Science ®Google Scholar
• Juniper EF, Kline PA, Vanzieleghem MA, et al. Long-term effects of budesonide on airway responsiveness and clinical asthma severity in inhaled steroid-dependent asthmatics. Eur Respir J 1990;3:1122–7
   PubMed Web of Science ®Google Scholar
• van Essen-Zandvliet EE, Hughes MD, Waalkens HJ, et al., Dutch CNSLD study group. Effects of 22 months treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. Am Rev Respir Dis 1992;146: 547–54
   Google Scholar
• van Essen Zandvliet EE. Long-term intervention in childhood asthma – the Dutch study results. Monaldi Arch Chest Dis 1995;50:201–7
   PubMedGoogle Scholar
• Pedersen S, Ramsgaard-Hansen O. Budesonide treatment of moderate and severe asthma in children: a dose response study. J Allergy Clin Immunol 1995;95:29–33
   PubMed Web of Science ®Google Scholar
• Blackwelder WC. Proving the null hypothesis in clinical trials. Controlled Clin Trials 1982;3:345–53
   PubMedGoogle Scholar
• Shapiro G, Bronsky EA, LaForce CF, et al. Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma. J Pediatr 1998;132:976–82
   PubMed Web of Science ®Google Scholar
• Borgström L. The pharmacokinetics of inhaled hydrofluoroalkane formulations. J Allergy Clin Immunol 1999;104:S246–9
   PubMed Web of Science ®Google Scholar
• Busse WW, Brazinsky S, Jacobson K, et al. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol 1999;104:1215–22
   PubMed Web of Science ®Google Scholar
• Kunka R, Andrews S, Pimazzoni M, et al. From hydrofluoroalkane pressurized metered dose inhalers (pMDIs) and comparability with chlorofluorocarbon pMDIs. Respir Med 2000;94(Suppl B):S10–6
   Google Scholar
• Ram FS, Brocklebank DM, White J, et al. Pressurised metered dose inhalers versus all other hand-held inhaler devices to deliver beta-2 agonist bronchodilators for non-acute asthma. Cochrane Database Syst Rev 2002;(1):CD002158
   Google Scholar
• Langley SJ, Houghton CM, Singh SD. Bronchoprotective and bronchodilator effects of an HFA pMDI vs a CFC pMDI and a DPI containing formoterol in asthma patients. Respiration 2005;72(Suppl 1):35–7
   Google Scholar