Long-term safety and efficacy of formoterol fumarate inhalation solution in patients with moderate-to-severe COPD

• Published in: International journal of chronic obstructive pulmonary disease 2019-01, Vol.14, p.117-127
• Main Authors: Hanania, Nicola A, Sethi, Sanjay, Koltun, Arkady, Ward, Jonathan K, Spanton, Jacqui, Ng, Dik
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Aged; Asthma; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; bronchodilators; Chronic obstructive pulmonary disease; COPD; Disease Progression; Double-Blind Method; Drug Administration Schedule; Drug dosages; Drug therapy; Drug withdrawal; Dyspnea; Female; Forced Expiratory Volume; Formoterol; Formoterol Fumarate - administration & dosage; Formoterol Fumarate - adverse effects; Hospitalization; Humans; Long-acting beta2-agonists; Lung - drug effects; Lung - physiopathology; Male; Medical research; Medicine, Experimental; Middle Aged; Mortality; nebulization; Nebulizers and Vaporizers; Original Research; Patient Admission; Pharmaceutical industry; Pharmaceutical Solutions; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - mortality; Pulmonary Disease, Chronic Obstructive - physiopathology; Questionnaires; Recovery of Function; Review boards; safety; Severity of Illness Index; Spirometry; Time Factors; Treatment Outcome; United States; Vital Capacity
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S173595

Formoterol fumarate inhalation solution (FFIS; Perforomist ) is a long-acting β -agonist (LABA) marketed in the US as a nebulized COPD maintenance treatment. Because long-term LABA use was associated with a potential increased risk of exacerbation or death in asthma patients, the US Food and Drug Administration (FDA) requested a postmarketing commitment study to evaluate long-term safety in COPD patients. This was a multicenter, randomized, double-blind, placebo-controlled, noninferiority study. Patients (N=1,071; mean age, 62.6 years; 48.5% male; 89.7% white) with moderate-to-severe COPD on stable COPD therapy received FFIS (20 µg; n=541) or placebo (n=530) twice daily. The primary end point was the combined incidence of respiratory death, first COPD-related ER visit, or first COPD exacerbation-related hospitalization during 1 year post randomization. Noninferiority to placebo was concluded if the two-sided 90% CI of the HR of FFIS to placebo was