Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: A randomised controlled trial

BMC Pulmonary Medicine

Volumn 11, Issue , 2011, Pages

  O'Connor, Brian J ^a   Collarini, Sara ^b   Poli, Gianluigi ^b   Brindicci, Caterina ^b   Spinola, Monica ^b   Acerbi, Daniela ^b   Barnes, Peter J ^c   Leaker, Brian ^a  

^a RESPIRATORY CLINICAL TRIALS LTD   (United Kingdom)

^b CHIESI FARMACEUTICI S P A   (Italy)

^c NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOSINE PHOSPHATE; ANTIASTHMATIC AGENT; BECLOMETASONE DIPROPIONATE; BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL; FORMOTEROL; FOSTER; NITRIC OXIDE; UNCLASSIFIED DRUG; BECLOMETASONE; BRONCHODILATING AGENT; ETHANOLAMINE DERIVATIVE;

ADULT; ANTIINFLAMMATORY ACTIVITY; ARTICLE; ASTHMA; BRONCHOSPASM; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; INHALER; LOW DRUG DOSE; MALE; MORNING DOSAGE; PROVOCATION TEST; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RESPIRATORY TRACT INFLAMMATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CROSSOVER PROCEDURE; DRUG COMBINATION; DRUG EFFECT; INHALATIONAL DRUG ADMINISTRATION; METERED DOSE INHALER; MIDDLE AGED; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANTI-ASTHMATIC AGENTS; ASTHMA; BECLOMETHASONE; BRONCHOCONSTRICTION; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; METERED DOSE INHALERS; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 83755174031     PISSN: None     EISSN: 14712466     Source Type: Journal    
DOI: 10.1186/1471-2466-11-60     Document Type: Article

References (29)

1. Bousquet J, Jeffery PK, Busse WW, Johnson M, Vignola AM. Asthma. From Bronchoconstriction to Airway Remodeling. Am J Respir Crit Care Med 2000, 161:1720-1745.
2. GINA: Global Initiative for Asthma. 2005, National Institutes of Health. National Heart, Lung and Blood Institute, updated Dec 2009.
3. Juniper EF, Kline Vanzieleghem MA, Ramsdale EH, O'Byrne PM, Hargreave FE. Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyper-responsiveness and clinical asthma in nonsteroid-dependent asthmatics. Am Rev Respir Dis 1990, 142(4):832-6.
4. Vanthenen AS, Knox AJ, Wisniewski A, Tattersfield AE. Time course of change in bronchial reactivity with an inhaled corticosteroid in asthma. Am Rv Respir Dis 1991, 143(6):1317-21.
5. Gibson PG, Saltos N, Fakes K. Acute anti-inflammatory effects of inhaled budesonide in asthma. Am J Respir Crit Care Med 2001, 163:32-36.
6. Ketchell RI, Jensen MW, Lumley P, Wright AM, Allenby MI, O'Connor BJ. Rapid effect of inhaled fluticasone propionate on airway responsiveness to adenosine 5'-monophosphate in mild asthma. J Allergy Clin Immunol 2002, 110:603-6. 10.1067/mai.2002.128486, 12373268.
7. Erin EM, Zacharasiewicz AS, Nicholson GC, Tan AJ, Neighbour H, Hansel TT, et al. Rapid effect of inhaled ciclesonide in asthma: a randomized, placebo-controlled study. Chest 2008, 134:740-745. 10.1378/chest.07-2575, 18403668.
8. Williams DM. Clinical considerations in the use of inhaled corticosteroids for asthma. Pharmacotherapy 2001, 21(3 Part 2):38S-48S. 10.1592/phco.21.4.38S.34260, 11253867.
9. Barnes PJ. Review: Scientific rationale for using a single inhaler for asthma control. Eur Respir J 2007, 29:587-595. 10.1183/09031936.00080306, 17329493.
10. 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(5):1480-7. 10.1378/chest.123.5.1480, 12740264.
11. Gibson PG, Powell H, Ducharme F. Long-acting beta2-agonists as an inhaled corticosteroid-sparing agent for chronic asthma in adults and children. Cochrane Database Syst Rev 2005, (4):CD005076. Review. PubMed PMID: 16235393.
12. Fabbri LM, Nicolini G, Olivieri D, Papi A. Inhaled beclometasone dipropionate/formoterol extra-fine fixed combination in the treatment of asthma: evidence and future perspectives. Expert Opin Pharmacother 2008, 9(3):479-490. 10.1517/14656566.9.3.479, 18220498.
13. Kharitonov SA, Barnes PJ. Clinical aspects of exhaled nitric oxide. Eur Respir J 2000, 16:781-792. 10.1183/09031936.00.16478100, 11106225.
14. Taylor DA, Jensen MW, Kanabar V, Engelstatter R, Steinijans VW, Barnes PJ, O'Connor BJ. A dose-dependent effect of the novel inhaled corticosteroid ciclesonide on airway responsiveness to adenosine-5'-9-monophosphate in asthmatic patients. Am J Respir Crit Care Med 1999, 160:237-242.
15. Majid H, Kao C. Utility of exhaled nitric oxide in the diagnosis and management of asthma. Current Opinion in Pulmonary Medicine 2010, 16; 1:42-47.
16. Ketchell RI, Jensen MW, Spina D, O'Connor BJ. Dose related effects of formoterol on airway responsiveness to adenosine 5'-monophosphate and histamine. Eur Respir J 2002, 19:611-616. 10.1183/09031936.02.00332001, 11998988.
17. Van den Berge M, Polosa R, Kerstjens HAM, Postma DS. The role of endogenous and exogenous AMP in asthma and chronic obstructive pulmonary disease. J Allergy Clin Immunol 2004, 114:737-46. 10.1016/j.jaci.2004.05.071, 15480309.
18. Ducharme FM, Ni Chroinin M, Greenstone I, Lasserson TJ. Addition of long-acting beta2-agonists to inhaled corticosteroids versus same dose inhaled corticosteroids for chronic asthma in adults and children. Cochrane Database Syst Rev: CD005535 Review 2010, PubMed PMID: 20464739.
19. Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomized, double-blind, cross-over study. Respiratory Research 2010, 11:66. 10.1186/1465-9921-11-66, 2890647, 20509942.
20. Daley-Yates P. Systemic bioavailability of beclometasone dipropionate (BDP) following inhaled, intranasal, oral and intravenous dosing in man. Eur Respir J 2000, 16(31):280.
21. Kharitonov SA, Gonio F, Kelly C, Meah S, Barnes PJ. Reproducibility of exhaled nitric oxide measurements in healthy and asthmatic adults and children. Eur Respir J 2003, 21(3):433-8. 10.1183/09031936.03.00066903a, 12661997.
22. ATS/ERS Recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide in adults and children. Am J Respir Crit Care Med 1999, 160:2104-2117. ATS/ERS.
23. Sterk PJ, Fabbri LM, Quanjer P, et al. Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults. Eur Respir J 1993, 6(Suppl 16):53-83.
24. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al. Standardisation of spirometry. Eur Respir J 2005, 26(2):319-338. 10.1183/09031936.05.00034805, 16055882.
25. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Eur Respir J 1993, 6(Suppl 16):5-40.
26. Kharitonov SA, Donnelly LE, Montuschi P, Corradi M, Collins JV, Barnes PJ, et al. Dose-dependent onset and cessation of action of inhaled budesonide on exhaled nitric oxide and symptoms in mild asthma. Thorax 2002, 57:889-896. 10.1136/thorax.57.10.889, 1746196, 12324677.
27. Committee for Medicinal Products for Human Use 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. European Medicine Agencies Doc Ref CPMP/EWP/4151/00 Rev 1, 22 January 2009.
28. Taylor DR, Pijnenburg MW, Smith AD, Jongste JCD. Exhaled nitric oxide measurements: clinical application and interpretation. Thorax 2006, 61:817-827. 10.1136/thx.2005.056093, 2117092, 16936238.
29. Aziz I, Andrew M, Lipworth W, BJ. Effects of Once-Daily Formoterol and Budesonide Given Alone or in Combination on Surrogate Inflammatory Markers in Asthmatic Adults. Chest 2000, 118:1049-1058. 10.1378/chest.118.4.1049, 11035676.