A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients

Pulmonary Pharmacology and Therapeutics

Volumn 25, Issue 3, 2012, Pages 248-253

  Singh, D ^a   Magnussen, H ^b   Kirsten, A ^b   Mindt, S ^c   Caracta, C ^d   Seoane, B ^e   Jarreta, D ^e   Garcia Gil, E ^e  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b KRANKENHAUS GROSSHANSDORF   (Germany)

^c Klinische Forschung Hamburg GmbH   (Germany)

^d FOREST RESEARCH INSTITUTE   (United States)

^e Almirall R and D Centre ^*  (Spain)

Author keywords

Aclidinium; AE; AUC; BID; Bronchodilation; COPD; DPI; ECG; FEV 1; FVC; ITT; LABA; LAMA; LS; Phase II; SAE; SE; TEAE; Twice daily

Indexed keywords

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE; PLACEBO; SALBUTAMOL;

ADULT; ARTICLE; BRONCHODILATATION; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG MONITORING; DRUG SAFETY; ECG ABNORMALITY; EVENING DOSAGE; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEADACHE; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; POWDER INHALER; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; TOOTH PAIN;

ADMINISTRATION, INHALATION; AGED; AREA UNDER CURVE; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ETHANOLAMINES; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME; TROPANES;

EID: 84860604953     PISSN: 10945539     EISSN: 15229629     Source Type: Journal    
DOI: 10.1016/j.pupt.2012.03.008     Document Type: Article

References (20)

1. Gavalda A., Miralpeix M., Ramos I., Otal R., Carreno C., Vinals M., et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. J Pharmacol Exp Ther 2009, 331:740-751.
2. Jansat J.M., Lamarca R., de Miquel G., Schrodter A., Miletzki B., Gurniak M. Safety and pharmacokinetics of multiple doses of aclidinium bromide, a novel long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease, in healthy participants. J Clin Pharmacol 2009, 49:1239-1246.
3. Jansat J.M., Lamarca R., Garcia Gil E., Ferrer P. Safety and pharmacokinetics of single doses of aclidinium bromide, a novel long-acting, inhaled antimuscarinic, in healthy subjects. Int J Clin Pharmacol Ther 2009, 47:460-468.
4. Sentellas S., Ramos I., Alberti J., Salva M., Anton F., Miralpeix M., et al. Aclidinium bromide, a new, long-acting, inhaled muscarinic antagonist: in vitro plasma inactivation and pharmacological activity of its main metabolites. Eur J Pharm Sci 2010, 39:283-290.
5. Gavalda A., Gras J., Llupia J., Aubets J., Beleta J., Llenas J. Aclidinium bromide, a novel long-acting muscarinic antagonist for COPD with improved preclinical renal and urinary safety profile. Life Sci 2012, 90:301-305.
6. Jones P.W., Rennard S.I., Agusti A., Chanez P., Magnussen H., Fabbri L., et al. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res 2011, 12:55.
7. Fuhr R., Magnussen H., Sarem K., Ribera Llovera A., Kirsten A.-M., Falques M., et al. Efficacy of aclidinium bromide 400 μg BID compared with placebo and tiotropium in patients with moderate-to-severe COPD. Chest 2011, 141:745-752.
8. Global Initiative for Chronic Obstructive Lung Disease Global Strategy for diagnosis, management, and Prevention of COPD 2010, http://www%20goldcopd.com.
9. Jones B., Kenward G. Design and analysis of crossover trials 2003, Chapman and Hall, London. 2nd ed.
10. Chrystyn H.N.C. The Genuair inhaler: a novel, multidose dry powder inhaler. Int J Clin Pract 2012, 66:309-317.
11. ®, a multidose dry powder inhaler. Respiration 2009, 78:322-328.
12. Molimard M., Till D., Stenglein S., Singh D., Krummen M. Inhalation devices for long-acting beta2-agonists: efficiency and ease of use of dry powder formoterol inhalers for use by patients with asthma and COPD. Curr Med Res Opin 2007, 23:2405-2413.
13. 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.
14. Donohue J.F. Minimal clinically important differences in COPD lung function. COPD 2005, 2:111-124.
15. Dahl R., Greefhorst L.A., Nowak D., Nonikov V., Byrne A.M., Thomson M.H., et al. Inhaled formoterol dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001, 164:778-784.
16. Rossi A., Kristufek P., Levine B.E., Thomson M.H., Till D., Kottakis J., et al. Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 2002, 121:1058-1069.
17. van Noord J.A., Aumann J.L., Janssens E., Smeets J.J., Verhaert J., Disse B., et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005, 26:214-222.
18. Joos G.F., Schelfhout V.J., Pauwels R.A., Kanniess F., Magnussen H., Lamarca R., et al. Bronchodilatory effects of aclidinium bromide, a long-acting muscarinic antagonist, in COPD patients. Respir Med 2010, 104:865-872.
19. Lavorini F., Magnan A., Dubus J.C., Voshaar T., Corbetta L., Broeders M., et al. Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med 2008, 102:593-604.
20. Molimard M., Raherison C., Lignot S., Depont F., Abouelfath A., Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med 2003, 16:249-254.