What is the role of Formoterol in Chronic Obstructive Pulmonary Disease (COPD)?

From the Guidelines

Formoterol is a recommended long-acting beta-2 agonist (LABA) for the maintenance treatment of COPD, as it improves lung function, reduces exacerbations, and enhances quality of life 1.

Key Points

• Formoterol is typically prescribed at a dose of 12 mcg inhaled twice daily, with common brand names including Foradil, Oxis, and Perforomist.
• It works rapidly (within 1-3 minutes) and provides bronchodilation for 12 hours, making it suitable for both maintenance therapy and quick symptom relief.
• In COPD management, formoterol is often combined with an inhaled corticosteroid (ICS) in products like Symbicort (formoterol/budesonide) or with a long-acting muscarinic antagonist (LAMA) for enhanced bronchodilation.
• Patients should be instructed to rinse their mouth after using formoterol to prevent oral thrush, and they should not exceed the prescribed dose.
• Formoterol improves lung function, reduces exacerbations, and enhances quality of life by relaxing airway smooth muscles through beta-2 receptor stimulation, which increases cyclic AMP and promotes bronchodilation.
• Common side effects include tremor, palpitations, and headache, and it should be used cautiously in patients with cardiovascular disease, diabetes, or thyroid disorders.

Benefits and Risks

• The use of formoterol in COPD patients has been shown to reduce the rate of severe exacerbations requiring hospitalizations, with an odds ratio (OR) of 0.73 (95% CI, 0.56-0.95) 1.
• Formoterol also improves quality of life, as measured by the SGRQ, with a significant improvement in SGRQ score of 22.32 (95% CI, 23.09 to 21.54) 1.
• The safety of formoterol has been established, with a similar rate of adverse events compared to placebo (OR, 0.97; 95% CI, 0.83-1.14) 1.

Clinical Guidelines

• The American College of Chest Physicians and Canadian Thoracic Society recommend the use of long-acting beta-2 agonists, such as formoterol, for the prevention of acute exacerbations of COPD (Grade 1B) 1.
• The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of long-acting bronchodilators, including formoterol, for the management of stable COPD 1.

From the FDA Drug Label

Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: • Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important limitations of use: • Formoterol Fumarate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.

Formoterol in COPD: Formoterol Fumarate Inhalation Solution is indicated for the long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema 2. However, it is not indicated to treat acute deteriorations of COPD.

From the Research

Formoterol in COPD

• Formoterol is a long-acting beta2-agonist that provides bronchodilation as rapidly as albuterol, yet its efficacy and duration of action are similar to those of salmeterol 3.
• It demonstrates better spirometric efficacy than either ipratropium or theophylline alone, and its efficacy improves when administered in combination with ipratropium 3.
• Formoterol improves patients' quality of life and has a good safety profile, being better tolerated than theophylline and having a similar tolerability to albuterol, salmeterol, and ipratropium 3.

Combination Therapy

• The combination of formoterol and tiotropium is more effective than single drugs alone in inducing bronchodilation and a bronchodilator-mediated symptom benefit in patients suffering from COPD 4.
• Twice-daily formoterol added to tiotropium is the best add-on option, providing better lung function and symptom improvement compared to tiotropium alone 4, 5.
• Combined formoterol and tiotropium treatment significantly improves lung function as well as symptoms and other patient-reported outcomes compared with tiotropium alone, regardless of smoking status, inhaled corticosteroid use, baseline severity, or gender 5.

Efficacy and Safety

• Formoterol is a highly selective and potent β2-agonist that relaxes airway smooth muscle to significantly improve lung function, with a rapid onset of action and a prolonged duration of action 6.
• Inhaled formoterol is an effective and safe treatment option for patients with moderate to severe COPD, providing improvements in lung function and COPD symptoms, reductions in the risk of exacerbations, and improvement in patients' health status 6.
• The adverse event profile of inhaled formoterol is similar to that of placebo, with few adverse cardiovascular events 6.