Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler®) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial

Pulmonary Pharmacology and Therapeutics

Volumn 30, Issue , 2015, Pages 121-127

  Kanniess, Frank ^a   Scuri, Mario ^b   Vezzoli, Stefano ^b   Francisco, Catherine ^c   Petruzzelli, Stefano ^b  

^a Practice for Allergy and Family Medicine   (Germany)

^b CHIESI FARMACEUTICI S P A   (Italy)

^c NONE   (France)

Author keywords

Asthma; Extrafine DPI; NEXThaler; PMDI

Indexed keywords

BECLOMETASONE DIPROPIONATE; CORTICOSTEROID; FORMOTEROL FUMARATE; ANTIASTHMATIC AGENT; BECLOMETASONE; ETHANOLAMINE DERIVATIVE; FORMOTEROL;

ADULT; AGED; ARTICLE; ASTHMA; CLINICAL EVALUATION; COMPARATIVE EFFECTIVENESS; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DRY POWDER INHALER; FEMALE; HEART PALPITATION; HUMAN; INHALATION; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MONOTHERAPY; MULTICENTER STUDY; PHARYNGITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK ASSESSMENT; SENSITIVITY ANALYSIS; THERAPY EFFECT; TREMOR; ADOLESCENT; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; PARTICLE SIZE; TREATMENT OUTCOME; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AGED; ANTI-ASTHMATIC AGENTS; ASTHMA; BECLOMETHASONE; DOUBLE-BLIND METHOD; DRY POWDER INHALERS; ETHANOLAMINES; FEMALE; HUMANS; MALE; METERED DOSE INHALERS; MIDDLE AGED; PARTICLE SIZE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84922817069     PISSN: 10945539     EISSN: 15229629     Source Type: Journal    
DOI: 10.1016/j.pupt.2014.07.006     Document Type: Article

References (24)

1. Bateman E. Global strategy for asthma management and prevention 2011, http://www.ginasthma.org.
2. Kanniess F., Richter K., Böhme S., Jörres R.A., Magnussen H. Montelukast vs. Fluticasone: effects on lung function, airway responsiveness and markers of inflammation in moderate asthma. Eur Respir J 2002, 20:853-858.
3. Pauwels R.A., Löfdahl C.G., Postma D.S., Tattersfield A.E., O'Byrne P., Barnes P.J., et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. NEngl J Med 1997, 337:1405-1411.
4. Suissa S., Ernst P., Benayoun S., Baltam M., Cai B. Low-dose inhaled corticosteorids and prevention of death from asthma. NEngl J Med 2000, 343:332-336.
5. Powell H., Gibson P.G. Inhaled corticosteroid doses in asthma: an evidence based approach. Med J Aust 2003, 178:223-225.
6. Haahtela T., Tamminen K., Kava T., Malmberg L.P., Rytilä P., Nikander K., Persson T., et al. Thirteen-year follow-up of early intervention with an inhaled corticosteroid in patients with asthma. JAllergy Clin Immunol 2009, 124:1180-1185.
7. Jentzsch N.S., Camargos P.A., Colosimo E.A., Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy 2009, 64:1458-1462.
8. Lasmar L., Camargos P., Champs N.S., Fonseca M.T., Fontes M.J., Ibiapina C., et al. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy 2009, 64:784-789.
9. Gamble J., Stevenson M., McClean E., Heaney L.G. The prevalence of nonadherence in difficult asthma. Am J Respir Crit Care Med 2009, 1(180):817-822.
10. Apter A.J., Reisine S.T., Affleck G., Barrows E., ZuWallack R.L. Adherence with twice-daily dosing of inhaled steroids. Socioeconomic and health-belief differences. Am J Respir Crit Care Med 1998, 157:1810-1817.
11. Single maintenance and reliever therapy (SMART) for asthma. Drug Ther Bull 2011, 49:126-129. [No authors listed].
12. Akazawa M., Stempel D.A. Single-inhaler combination therapy for asthma: a review of cost effectiveness. Pharmacoeconomics 2006, 24:971-988.
13. Papi A., Paggiaro P.L., Nicolini G., Vignola A.M., Fabbri L.M. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J 2007, 29:682-689.
14. Scichilone N., Spatafora M., Battaglia S., Arrigo R., Benfante A., Bellia V. Lung penetration and patient adherence considerations in the management of asthma: role of extra-fine formulations. JAsthma Allergy 2013, 6:11-21.
15. Miller M.R., Hankinson J., Brusasco V., Burgos F., Casaburi R., Coates A., et al. Standardisation of spirometry. Eur Respir J 2005, 26:319-338.
16. Quanjer P.H., Tammeling G.J., Cotes J.E., Pedersen O.F., Peslin R., Yernault J.C. Lung volumes and forced ventilatory flows. Report working party standardization of lung function tests, european community for steel and coal. official statement of the European respiratory society. Eur Respir J 1993, 16:5-40.
17. Richter K., Kanniess F., Marck B., Jörres R.A., Magnussen H. Assessment of accuracy and applicability of a new electronic peak-flow meter and asthma monitor. Eur Respir J 1998, 12:457-462.
18. Reddel H.K., Taylor D.R., Bateman E.D., Boulet L.P., Boushey H.A., Busse W.W., et al. An official american thoracic society/European respiratory society statement: asthma control and exacerbations. Am J Respir Crit Care Med 2009, 180:59-99.
19. Ebbutt A.F., Frith L. Practical issues in equivalence trials. Statistics Med 1998, 17:1691-1701.
20. Godard P., Greillier P., Pigearias B., Nachbaur G., Desfougeres J.L., Attali V. Maintaining asthma control in persistent asthma: comparison of three strategies in a 6-month double-blind randomised study. Respir Med 2008, 102:1124-1131.
21. Santanello N.C., Zhang J., Seidenberg B., Reiss T.F., Barber B.L. What are minimal important changes for asthma measures in a clinical trial?. Eur Resp J 1999, 14:23-27.
22. Barnes P.J. Scientific rational for using a single inhaler for asthma control. Eur Resp J 2007, 29:587-595.
23. Nadarassan D.K., Assi K.H., Chrystyn H. Aerodynamic characteristics of a dry powder inhaler at low inhalation flows using a mixing inlet with an andersen cascade impactor. Eur J Pharm Sci 2010 Mar 18, 39:348-354.
24. Virchow J.C., Crompton G.K., Dal Negro R., Pedersen S., Magnan A., Seidenberg J., et al. Importance of inhaler devices in the management of airway disease. Respir Med 2008, 102:10-19.