What are the FDA (United States Food and Drug Administration) approved drugs for Chronic Obstructive Pulmonary Disease (COPD)?

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Last updated: May 30, 2025View editorial policy

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From the Guidelines

The FDA has approved several medications for the management of chronic obstructive pulmonary disease (COPD), including bronchodilators, combination inhalers, and triple therapy inhalers, as recommended by the 2023 Canadian Thoracic Society guideline on pharmacotherapy in patients with stable COPD 1.

FDA Approved Medications for COPD

The following medications are approved for the management of COPD:

  • Bronchodilators:
    • Short-acting beta-agonists (albuterol, levalbuterol)
    • Short-acting muscarinic antagonists (ipratropium)
    • Long-acting beta-agonists (salmeterol, formoterol, indacaterol, olodaterol, arformoterol)
    • Long-acting muscarinic antagonists (tiotropium, umeclidinium, aclidinium, glycopyrrolate)
  • Combination inhalers:
    • LABA/LAMA combinations (umeclidinium/vilanterol, tiotropium/olodaterol, glycopyrrolate/formoterol, glycopyrrolate/indacaterol)
    • Inhaled corticosteroid/LABA combinations (fluticasone/salmeterol, budesonide/formoterol, fluticasone/vilanterol, fluticasone/formoterol)
  • Triple therapy inhalers:
    • ICS/LABA/LAMA (fluticasone/umeclidinium/vilanterol, budesonide/glycopyrrolate/formoterol)
  • Other medications:
    • Phosphodiesterase-4 inhibitors (roflumilast)
    • Systemic corticosteroids

Treatment Approach

Treatment of COPD typically follows a stepwise approach based on symptom severity and exacerbation history, with the goal of alleviating symptoms, improving health status, and reducing exacerbations and mortality 1. The use of LABD maintenance therapy is recommended in all individuals who have persistent symptoms, even mild, with COPD, and LAMA/LABA dual therapy is strongly recommended over LAMA or LABA monotherapy in individuals with moderate to severe dyspnea and reduced health status.

Considerations

When selecting an inhaler device, factors such as patient inhaler technique, preference, cost/insurance coverage, and clinical course should be considered, as well as the environmental impact of the device 1. The environmental impact of metered dose inhalers (MDIs) should be taken into account, and dry-powder inhalers or emerging devices with novel propellants may be a lower carbon footprint option.

From the FDA Drug Label

ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD

The FDA-approved drug for COPD mentioned in the label is:

  • Ipratropium bromide inhalation solution 2 Note that the label only mentions one FDA-approved drug for COPD.

From the Research

FDA Approved Drugs for COPD

The following are some of the FDA approved drugs for COPD:

  • Tiotropium bromide (Spiriva) 3
  • Salmeterol (a long-acting beta(2)-adrenoceptor agonist) 4, 5
  • Formeterol (a long-acting beta(2)-adrenoceptor agonist) 4, 5
  • Combination therapy of a long-acting beta(2)-adrenoceptor agonist and an anticholinergic, such as Combivent (a combination of salbutamol and ipratropium bromide) 4

Long-Acting Bronchodilators

Long-acting bronchodilators are the mainstay of maintenance treatment of COPD, and can be classified into two categories:

  • Long-acting beta-2 agonists (LABAs) 6
  • Long-acting muscarinic antagonists (LAMAs) 6 These drugs have been shown to safely reduce the frequency of exacerbations, alleviate symptoms, and improve quality of life, exercise tolerance, and lung function of patients with COPD 6, 7

Treatment Algorithm

A treatment algorithm for the introduction of long-acting bronchodilators to patients with COPD has been proposed, which includes the use of long-acting bronchodilators early in the treatment algorithm 5 Tiotropium appears to be the best option as a first-line drug for patients with moderate-to-severe COPD because of its ability to sustain bronchodilator effect, improve quality of life, reduce COPD exacerbations, and reduce health resource usage 7

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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