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Randomized Controlled Trial
. 2014 Nov;78(5):1169-71.
doi: 10.1111/bcp.12424.

A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents

Bo L Chawes  1 , Mirco Govoni, Annalisa Piccinno, Eskil Kreiner-Møller, Nadja H Vissing, Li Mortensen, Erik Nilsson, Amalie Bisgaard, Maja Deleuran, Nanna Skytt, Nasim Samandari, Daniela Acerbi, Hans Bisgaard
Affiliations
Randomized Controlled Trial

A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents

Bo L Chawes et al. Br J Clin Pharmacol. 2014 Nov.
No abstract available

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References

    1. Kips JC, O'Connor BJ, Inman MD, Svensson K, Pauwels RA, O'Byrne PM. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. Am J Respir Crit Care Med. 2000;161:996–1001. - PubMed
    1. Lalloo UG, Malolepszy J, Kozma D, Krofta K, Ankerst J, Johansen B, Thomson NC. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Chest. 2003;123:1480–1487. - PubMed
    1. Zuccaro F, Sergio F, Petruzzelli S, Singh D. Therapeutic equivalence of beclomethasone dipropionate/formoterol administered via NEXT™ DPI with beclomethasone dipropionate/formoterol administered via HFA pMDI in adult asthmatic patients. Eur Respir J. 2010;36(Suppl. 54):P4540.
    1. Chawes B, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013;75:1081–1088. - PMC - PubMed
    1. EMA. 2009. Guideline on the requirements for clinical documentation for orally inhaled products (oip) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (copd) in adults and for use in the treatment of asthma in children and adolescents. Doc. Ref. CPMP/EWP/4151/00 Rev. 1 – – 22 January.

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