Should a combined Inhaled Corticosteroid (ICS)-Long-Acting Beta-Agonist (LABA) not be prescribed for Chronic Obstructive Pulmonary Disease (COPD)?

From the Guidelines

A combined ICS-LABA should not be prescribed as first-line therapy for all COPD patients, but rather reserved for specific patient populations, such as those with a history of frequent exacerbations or elevated blood eosinophil counts, due to the potential risks of increased pneumonia and other adverse events, as suggested by the 2023 Canadian Thoracic Society guideline on pharmacotherapy in patients with stable COPD 1. The initial treatment for most COPD patients should focus on bronchodilation with a long-acting muscarinic antagonist (LAMA) or a LABA. ICS-LABA combinations should be considered for patients with specific characteristics, such as:

• A history of frequent exacerbations (two or more moderate exacerbations or one hospitalization per year)
• Elevated blood eosinophil counts (typically >300 cells/μL)
• Concomitant asthma For patients with severe COPD who continue to experience exacerbations despite dual bronchodilator therapy (LAMA+LABA), triple therapy adding an ICS may be appropriate. Some key points to consider when prescribing ICS-LABA combinations include:
• The potential benefits of reduced inflammation and exacerbation risk
• The potential risks of increased pneumonia, oral candidiasis, hoarse voice, and potential bone density effects
• The importance of proper inhaler technique instruction and regular assessment of adherence
• The consideration of alternative therapies, such as LAMA/LABA dual therapy or triple therapy with a single inhaler, for patients who are at high risk of exacerbations or have specific characteristics that may benefit from these therapies, as suggested by the 2023 Canadian Thoracic Society guideline on pharmacotherapy in patients with stable COPD 1.

From the FDA Drug Label

INDICATIONS AND USAGE Wixela Inhub® is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. (1.1) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2) Important limitation of use: Not indicated for relief of acute bronchospasm. (1.1.2)

The answer is no, a combined ICS-LABA should not be avoided for COPD, as it is actually indicated for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD 2.

From the Research

COPD Treatment with ICS-LABA

• The use of a combined inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) treatment is a topic of debate, with some studies suggesting that it may not be the most effective treatment option for all patients 3, 4, 5.
• A study published in Chest found that the triple combination of LAMA, LABA, and ICS inhalers is generally as effective as combining LAMA and LABA inhalers in preventing COPD exacerbations, but may be associated with an increased risk of severe pneumonia 3.
• Another study published in the International journal of chronic obstructive pulmonary disease found that triple therapy (ICS/LABA/LAMA) can reduce the risk of exacerbations and improve lung function and health status in patients with COPD, but may not be necessary for all patients 6.
• A study published in Advances in therapy found that tiotropium/olodaterol was associated with a lower risk of COPD exacerbations, pneumonia, and escalation to triple therapy compared to LABA/ICS, suggesting that a LAMA/LABA combination may be a better treatment option for some patients 5.

Patient-Specific Treatment

• The decision to prescribe a combined ICS-LABA for COPD should be based on individual patient characteristics, such as blood eosinophil counts and exacerbation history 4, 7.
• A study published in the International journal of chronic obstructive pulmonary disease found that patients with blood eosinophil counts ≥ 100 cells/μL and a history of moderate to severe exacerbations may benefit from triple therapy (ICS/LABA/LAMA) as first-line treatment 7.
• Another study published in Nihon rinsho. Japanese journal of clinical medicine suggested that ICS/LABA or ICS/LAMA should be prescribed to patients with asthma-COPD overlap, as they may not respond well to bronchodilation therapy alone 4.

Treatment Risks and Benefits

• The use of ICS in COPD treatment has been associated with an increased risk of pneumonia, particularly in patients with severe COPD 3, 5.
• However, ICS can also reduce the risk of exacerbations and improve lung function in patients with COPD, particularly those with high blood eosinophil counts 4, 6.
• The benefits and risks of ICS-LABA treatment should be carefully weighed for each individual patient, taking into account their medical history, lung function, and other factors 3, 5.