• Yes, Trelegy Ellipta (generic name: fluticasone furoate / umeclidinium / vilanterol) is now approved for the maintenance treatment of asthma in patients aged 18 years and older.
• Trelegy Ellipta is also approved for use in adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
• Trelegy Ellipta is not used as a fast-acting (rescue) inhaler for the relief of acute bronchospasm.

Trelegy Ellipta is a once-daily therapy that combines three medicines into one inhaler. It combines an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA).

Trelegy Ellipta is not a fast-acting rescue medicine to be used during an asthma attack. It does not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine (for example, albuterol) for an attack. If you do not have a fast-acting rescue inhaler, contact your health care provider to have one prescribed for you.

In September 2017, the FDA approved Trelegy Ellipta for the long-term maintenance of chronic obstructive pulmonary disease (COPD). In April 2018, the indications were expanded to include the daily maintenance treatment of airflow obstruction in patients with COPD. In September 2020, the FDA approved a third indication for Trelegy for maintenance treatment of asthma in adults.

What are the 3 medications in Trelegy?

Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol) contains three medications in one inhaler for the treatment of adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for the treatment of asthma. Because it contains three medicines, it may be useful for those on a fixed-dose combination of fluticasone / vilanterol (Breo Ellipta) who need added bronchodilation, or those who are already using Breo Ellipta and Incruse Ellipta (umeclidinium).

Trelegy Ellipta contains:

• fluticasone, a corticosteroid that lowers inflammation (swelling) in your airways
• vilanterol, a long-acting beta-agonist (LABA) that relaxes your airway muscles
• umeclidinium, an anticholinergic drug to widen the airways in your lungs.

Long-acting beta2-adrenergic agonist (LABA) medicines such as vilanterol are used with other medicines and are not used alone in asthma. When LABAs are used alone, it can increase the risk of hospitalizations and death from asthma problems. When an inhaled corticosteroid and a long-acting beta2-adrenergic agonist (LABA) are used together, there is not a significantly increased risk in hospitalizations and death from asthma problems.

Trelegy Ellipta should not be used in children. It is not known if Trelegy Ellipta is safe and effective in children.

Is Trelegy approved for asthma?

Yes, Trelegy is now approved to be used for asthma in adults. In October 2019, GSK and Innoviva submitted a supplemental new drug application (sNDA) to the FDA for approval of Trelegy Ellipta as a once-daily treatment for adults with asthma. Trelegy Ellipta is the first single inhaled, once-daily triple therapy available for both asthma and COPD in the U.S.

Phase III CAPTAIN Study for Ellipta

Approval for asthma was based on the Phase III CAPTAIN study that evaluated once-daily fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) in the treatment of patients with asthma. Trelegy Ellipta is now an option for patients who need more control than offered by standard dual therapy regimen with only inhaled corticosteroids and a long-acting beta2-adrenergic agonist (LABA).

In the CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) study, a significant improvement in lung function was demonstrated with two different strengths of fluticasone furoate / umeclidinium / vilanterol: 100/62.5/25 mcg and 200/ 62.5/25 mcg. Over 2,400 adult patients were included.

• Improvement in lung function was measured by the change from baseline in trough forced expiratory volume over one second (FEV1) at 24 weeks of treatment.
• Compared to Breo (fluticasone furoate / vilanterol) 100/25 mcg, Trelegy Ellipta 100/62.5/25 mcg once daily demonstrated a 110 mL significant improvement in FEV1 at 24 weeks (95% CI: 66-153 mL, p<0.001).
• When Trelegy Ellipta 200/62.5/25 mcg once daily, triple therapy was compared to Breo 200/25 mcg dual therapy, a significant improvement of 92 mL in trough FEV1 was seen for Trelegy (95% CI: 49-135 mL, p<0.001).

The safety profile of Trelegy Ellipta in this study was consistent with the known profile of the individual components and their combinations.

• The most common side effects included common cold symptoms (13% to 15%), headache (5% to 9%), upper respiratory tract infection (3% to 6%), and bronchitis (3% to 5%).
• Additional common side effects reported in the package insert include sinusitis / acute sinusitis, urinary tract infection, rhinitis (runny or stuffy nose), influenza (flu), headache, and back pain.

The FDA-approved strength for treatment of both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone (not for COPD) which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.

Bottom Line

• Trelegy Ellipta is approved for both the once-daily treatment of adults with chronic obstructive pulmonary disease (COPD) or asthma. Trelegy Ellipta is an option for the treatment of asthma in patients not controlled on inhaled corticosteroids and long-acting beta agonists alone.
• Trelegy Ellipta combines three medicines to improve lung function: fluticasone, a corticosteroid, vilanterol, a long-acting beta-agonist (LABA), and umeclidinium, an anticholinergic drug to widen the large airways. Vilanterol is NOT used alone for the treatment of asthma. Trelegy is not used for the relief of acute bronchospasm.
• Phase 3 studies have demonstrated a significant effect of Trelegy Ellipta in the maintenance treatment of asthma. Trelegy Ellipta is approved in two strengths for asthma: fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg and fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg, both given once daily.

This is not all the information you need to know about Trelegy Ellipta for safe and effective use. Review the full Trelegy Ellipta information here, and discuss this information with your doctor or other health care provider.