Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

Therapeutic Advances in Respiratory Disease

Volumn 2, Issue 4, 2008, Pages 199-208

  Donohue, James F ^a   Hanania, Nicola A ^b   Fogarty, Charles ^c   Campbell, Sammy C ^d   Rinehart, Mike ^e   Denis Mize, Kimberly ^e  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c Southeast Clinical Oncology Research   (United States)

^d Southern Arizona VA Healthcare System   (United States)

^e Dey LP   (United States)

Author keywords

bronchodilation; COPD; formoterol; 2 agoinst

Indexed keywords

FLUTICASONE; FORMOTEROL FUMARATE; FUROSEMIDE; IPRATROPIUM BROMIDE; PERFOROMIST; PLACEBO; PREDNISONE; SALBUTAMOL; THEOPHYLLINE; TIOTROPIUM BROMIDE;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY POWDER; DYSPNEA; FEMALE; HEART ARREST; HEART ARRHYTHMIA; HEART INFARCTION; HEART PALPITATION; HUMAN; HYPERGLYCEMIA; HYPERNATREMIA; HYPERTENSION; HYPERURICEMIA; INSOMNIA; LEUKOCYTOSIS; LONG TERM CARE; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEBULIZATION; NEBULIZER; OPEN STUDY; PATIENT COMPLIANCE; PNEUMONIA; POTASSIUM BLOOD LEVEL; POWDER INHALER; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; TACHYCARDIA; TOOTH ABSCESS; TREATMENT DURATION; TREMOR; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VITAL SIGN;

ADMINISTRATION, INHALATION; BLOOD PRESSURE; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; ETHANOLAMINES; FEMALE; HEART RATE; HUMANS; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; POWDERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX;

EID: 68749083915     PISSN: 17534658     EISSN: None     Source Type: Journal    
DOI: 10.1177/1753465808093934     Document Type: Article

References (37)

1. Aalbers, R., Ayres, J., Backer, V., Decramer, M., Lier, P.A., Magyar, P. et al. (2002) Formoterol in patients with chronic obstructive pulmonary disease: a randomized, controlled, 3-month trial. Eur Respir J 19: 936-943.
2. Appleton, S., Poole, P., Smith, B., Veale, A., Lasserson, T.J., Chan, M.M. et al. (2006) Long-acting beta2-agonists for poorly reversible chronic obstructive pulmonary disease. Cochrane database of systematic reviews (online) 3: CD001104.
3. Barta, S.K., Crawford, A. and Roberts, C.M. (2002) Survey of patients’ views of domiciliary nebuliser treatment for chronic lung disease. Respir Med 96: 375-381.
4. Berger, W.E. and Nadel, J.A. (2008) Efficacy and safety of formoterol for the treatment of chronic obstructive pulmonary disease. Respir Med 102: 173-188.
5. Calvarley, P.M., Boonsawat, W., Cseke, Z., Zhong, N., Peterson, S. and Olsson, H. (2003) Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 22: 912-919.
6. Calverley, P.M.A., Anderson, J.A., Celli, B., Ferguson, G.T., Jenkins, C., Jones, P.Q. et al. (2007) Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 356: 775-789.
7. Campbell, M., Eliraz, A., Johansson, G., Tornling, G., Nihlen, U., Bengtsson, T. et al. (2005) Formoterol for maintenance and as-needed treatment of chronic obstructive pulmonary disease. Respir Med 99: 1511-1520.
8. Campbell, S.C., Criner, G.J., Levine, B.E., Simon, S.J., Smith, J.S., Orevillo, C.J. et al. (2007) Cardiac safety of formoterol 12 µg twice daily in patients with chronic obstructive pulmonary disease. Pulm Pharmacol Ther 20: 571-579.
9. Carpenter, M., Kim, K.T., Denis-Mize, K. and Rinehart, M. (2008) A pharmacokinetic study in COPD patients comparing formoterol fumarate delivered by nebulization and DPI [abstract]. Am J Resp Crit Care Med 177: A648.
10. Cazzola, M., Matera, M.G. and Donner, C.F. (2005) Inhaled βx-adrenoceptor agonists. Cardiovascular safety in patients with obstructive lung disease. Drugs 65: 1595-1610.
11. Cazzola, M. and Matera, M.G. (2007) Safety of long-acting β2-agonists in the treatment of asthma. Ther Adv Resp Dis 1: 35-45.
12. Cheer, S.M. and Scott, L.J. (2002) Formoterol: a review of its use in chronic obstructive pulmonary disease. Am J Respir Med 1: 285-300.
13. Colice, G.L., Carnathan, B., Sung, J. and Paramore, L.C. (2005) A respiratory therapist-directed protocol for managing inpatients with asthma and COPD incorporating a long-acting bronchodilator. J Asthma 1: 29-34.
14. Dahl, R., Greefhorst, L.A.P.M., Nowak, D., Nonikov, V., Byrne, A.M., Thomson, M.H. et al. (2001) Inhaled formoterol; dry powder versus ipratropium bromide in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 164: 778-784.
15. Dolovich, M.B., Ahrens, R.C., Hess, D.R., Anderson, P., Dhand, R., Rau, J.L. et al. (2005) Device selection and outcomes of aerosol therapy: evidence-based guidelines. Chest 127: 335-371.
16. Fabbri, L.M., Luppi, F., Beghe, B. and Rabe, K.F. (2008) Complex chronic comorbidities of COPD. Eur Respir J 31: 204-212.
17. Ferguson, G., Funck-Brentano, C., Fischer, T., Darken, P. and Reisner, C. (2003) Cardiovascular safety of salmeterol in COPD. Chest 123: 1817-1824.
18. Global Initiative for chronic obstructive lung disease (GOLD). Report of the GOLD workshop, global strategy for diagnosis, management and prevention of COPD. 2006 update. Available at: http://www.goldcopd.org
19. Gross, N.J., Kerwin, E., Levine, B., Denis-Mize, K. and Rinehart, M. (2008a) Dose-ranging study in COPD patients comparing pharmacodynamics of formoterol fumarate delivered by nebulization and DPI [abstract]. Am J Respir Crit Care Med 177: A648.
20. Gross, N.J., Nelson, H.S., Lapidus, R., Dunn, L., Lynn, L., Rinehart, M. et al. (2008b) Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med 102: 189-197.
21. Mann, M., Chowdhury, B., Sullivan, E., Nicklas, R., Anthracite, R. and Meyer, R.J. (2003) Serious asthma exacerbations in asthmatics treated with high-dose formoterol. Chest 124: 70-74.
22. Nelson, H.S., Weiss, S.T., Bleecker, E.R., Yancey, S.W. and Dorinsky, P.M. (2006) The salmeterol multicenter asthma research trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 129: 15-26.
23. Nelson, H.S., Gross, N.J., Levine, B., Kerwin, E.M., Rinehart, M. and Denis-Mize, K. (2007) Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, double-blind, double-dummy, placebo- and active-controlled trial. Clin Ther 29: 2167-2178.
24. O'Driscoll, B.R. and Bernstein, A. (2006) A long-term study of symptoms, spirometry and survival amongst home nebulizer users. Respir Med 90: 561-566.
25. Ogale, S.S., Lee, T.A. and Sullivan, S.D. (2006) Risk of cardiovascular events associated with inhaled long-acting beta-2-adrenoreceptor agonists in patients with chronic obstructive pulmonary disease [abstract]. Chest 130: 121S-122S.
26. Rossi, A., Kristufek, P., Levine, B., Thomson, M.H., Till, D., Kottakis, J., et al. (2002) Comparison of the efficacy, tolerability, and safety of formoterol dry powder and oral, slow-release theophylline in the treatment of COPD. Chest 121: 1058-1069.
27. Rutten, F.H., Cramer, M.-J.M., Grobbee, D.E., Sachs, A.P.E., irkels, J.H., Lammers, J.-W.J. et al. (2005) Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J 26: 1887-1894.
28. Salpeter, S.R., Buckley, N.S., Ormiston, T.M. and Salpeter, E.E. (2006) Meta-analysis: effect of long-acting β-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med 144: 904-912.
29. Shih, H.-T., Webb, C.R., Conway, W.A., Peterson, E., Tilley, B. and Goldstein, S. (1988) Frequency and significance of cardiac arrhythmias in chronic obstructive lung disease. Chest 94: 44-48.
30. Sin, D.D., Anthonisen, N.R., Soriano, J.B. and Agusti, A.G. (2006) Mortality in COPD: role of comorbidities. Eur Respir J 28: 1245-1257.
31. Sovani, M.P., Whale, C.I. and Tattersfield, A.E. (2004) A benefit-risk assessment of inhaled long-acting β -agonists in the management of obstructive pulmonary disease. Drug Safety 27: 689-715.
32. Szafranski, W., Cukier, A., Ramirez, A., Menga, G., Sansores, R., Nahabedian, S. et al. (2003) Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 21: 74-81.
33. Tashkin, D.P., Littner, M., Andrews, C.P., Tomlinson, L., Rinehart, M. and Denis-Mize, K. (2008) Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med 102: 479-487.
34. Thompson, J., Irvine, T., Grathwohl, K. and Roth, B. (1994) Misuse of metered-dose inhalers in hospitalized patients. Chest 105: 715-717.
35. van Beerendonk, I., Mesters, I., Mudde, A.N. and Tan, T.D. (1998) Assessment of the inhalation technique in outpatients with asthma or chronic obstructive pulmonary disease using a metered-dose inhaler or dry powder device. J Asthma 35: 273-279.
36. Wilton, L.V. and Shakir, S.A. (2002) A post-marketing surveillance study of formoterol (Foradil®). Drug Saf 25: 213-223.
37. Yohannes, A.M. and Hardy, C.C. (2003) Treatment of chronic obstructive pulmonary disease in older patients. Drugs Aging 20: 209-228.