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

University of North Carolina, 4125 BioInformatics Building, 130 Mason Farm Road, CB 7020, Chapel Hill, NC, 27599, USA, james_donohue{at}med.unc.edu

Nicola A. Hanania

Baylor College of Medicine, 1504 Taub Loop, Houston, TX, 77030, USA

Charles Fogarty

Spartanburg Medical Research, 485 Simuel Road, Spartanburg, SC, 29303, USA

Sammy C. Campbell

Southern Arizona VA, Pulmonary Section, 3601 S 6th Avenue, Tucson, AZ, 85723, USA

Mike Rinehart

LP, 2751 Napa Valley Corporate Drive, Napa, CA, 94558, USA

Kimberly Denis-Mize

LP, 2751 Napa Valley Corporate Drive, Napa, CA, 94558, USA

Formoterol fumarate is a long-acting β2-agonist that is an effective bronchodilator for the maintenance management of patients with chronic obstructive pulmonary disease. The safety profile of the newly developed nebulized formoterol was evaluated over a twelve-month period in an open-label, active-control study. After completing a twelve-week double-blind double-dummy period, 569 subjects with chronic obstructive pulmonary disease entered an open-label extension study and received twice-daily 20 µg formoterol fumarate inhalation solution for nebulization (FFIS) or 12 µg formoterol fumarate dry powder inhalation (FA) for 52 weeks. Most of the FFIS-treated subjects (86%) completed at least six months of open-label treatment with over 90% compliance, comparable to the FA group (88%). Results of safety monitoring for adverse events, laboratory values, and cardiac changes were similar between treatment groups. Three hundred forty (73%) of FFIS-treated subjects and 83 (78%) of FA-treated subjects experienced an adverse event over the course of the study, the majority of which were mild to moderate and considered unrelated to treatment. COPD exacerbation occurred in 15.8% of FFIS-treated and 17.9% of FA-treated subjects. Deaths, serious adverse events, and discontinuations for adverse events occurred in 1.3, 16.2, and 5.4% of the nebulized group versus 1.9, 17.9, and 7.5% of the inhaled group, respectively. There were no clinically important changes from baseline in laboratory tests, including serum potassium and glucose, or vital signs and no treatment-related increases in cardiac arrhythmias, heart rate, or QTc prolongation. We conclude that nebulized formoterol fumarate twice daily is well tolerated over long-term treatment in moderate-to-severe COPD subjects and has a similar safety profile to the DPI formulation.

Key Words: COPD • formoterol • β2-agoinst • bronchodilation

Therapeutic Advances in Respiratory Disease, Vol. 2, No. 4, 199-208 (2008)
DOI: 10.1177/1753465808093934


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