Key Points

Trelegy Ellipta (generic name: fluticasone furoate/umeclidinium/vilanterol) is a once-daily triple drug inhaler approved for long-term use in asthma or chronic obstructive pulmonary disease (COPD) and must be used daily to be effective. Trelegy Ellipta is NOT used as a fast-acting rescue inhaler for sudden breathing problems. It is a maintenance medicine for long-term use to help prevent flare-ups.

Each person's response to medicine can be different. How quickly this medicine works for you will depend upon your previous treatments, your symptoms and lung function, and tolerance. Your doctor knows your medical condition the best and can give you a timeline of your treatment response.

Trelegy Ellipta was studied in over 10,000 patients with symptomatic chronic obstructive pulmonary disease (COPD) and a history of prior exacerbations (flare-ups).

• Over one year, triple therapy with Trelegy was shown to improve rates of COPD flare-ups, improve lung function (FEV1), quality of life and rates of hospitalizations when compared to dual therapy such as Breo Ellipta (fluticasone and vilanterol) or Anoro Ellipta (umeclidinium and vilanterol).
• Rates of pneumonia were higher in the Trelegy Ellipta group.

Trelegy Ellipta is also approved for the once-daily maintenance (long-term) treatment of asthma in adults.

• In asthma studies, Trelegy Ellipta was compared to Breo (fluticasone furoate and vilanterol), both given once daily in aptients not controlled on the dual therapy.
• A significant improvement in trough FEV1 from baseline (the primary endpoint) was demonstrated at week 24 for Trelegy Ellipta.

Trelegy Ellipta is approved in two strengths for use in asthma: 100/62.5/25 mcg and 200/62.5/25 mcg, while only the 100/62.5/25mcg strength is approved in COPD.

Does Trelegy work right away?

Trelegy Ellipta is not a rescue medicine for bronchospasm attacks and sudden breathing problems. Use only your fast-acting inhalation medicine (for example, albuterol) for an attack. If you do not have a fast-acting inhaler, call your doctor for a prescription. Seek emergency medical treatment or call 911 if your breathing problems get worse quickly.

Trelegy is approved as a maintenance (long-term) medicine for use in either chronic obstructive pulmonary disease (COPD) or asthma in adults.

Which long-acting medicines are in Trelegy?

Trelegy Ellipta contains three long-acting medications:

• fluticasone, an inhaled corticosteroid that lowers inflammation and swelling in the lung airways
• vilanterol, a long-acting beta-agonist (LABA) bronchodilator that relaxes the airway muscles to help open airways
• umeclidinium, a long-acting muscarinic antagonist (LAMA), an anticholinergic bronchodilator that helps to block muscle tightening around your airways to improve breathing.

Trelegy is used once daily in adults with either asthma or COPD to help breathing symptoms and reduce the number of flare-ups by lowering the swelling in your lungs and relaxing your airways.

Trelegy is only inhaled once per day because the medication effect lasts for at least 24 hours. Use your Trelegy Ellipta inhaler at the same time every day.

How fast did Trelegy Ellipta work in studies?

Trelegy Ellipta has been evaluated in the treatment of asthma or COPD in studies ranging from 12- to 52-weeks long.

In studies, Trelegy has shown a positive effect on breathing tests (FEV1) with the first dose, but it may take several weeks or longer for your overall symptoms to improve in COPD or asthma.

COPD

• In 1-year long clinical studies, Trelegy demonstrated a significant 15% reduction in moderate-to-severe COPD flare-ups (exacerbations) when compared to Breo Ellipta. It also had a 25% reduction in flare-ups compared to Anoro Ellipta.
• Triple therapy with Trelegy also resulted in a lower rate of hospitalization due to COPD than umeclidinium–vilanterol (Anoro).
• Trelegy led to a superior and significant lung function (FEV1) improvement when compared to Breo and Anoro over one year.
• Based on a survey for secondary outcomes, Trelegy also improved patient’s health-related quality of life when compared to Breo, which included items such as daily symptoms, daily activities and perceived well-being.
• Rates of pneumonia were higher in patients receiving Trelegy triple therapy (8%) compared to Anoro (5%) or Breo (7%) in a 52-week study.
• Improvements in lung function have also been seen when Trelegy was compared to Symbicort Turbuhaler in 24-week studies or with Symbicort plus Spiriva in 12 week studies.

Asthma

• In studies of patients with asthma, a significant improvement in lung function (FEV-1) was seen at 24- and 52-weeks when compared to the use of Breo (fluticasone and vilanterol).
• 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 over a 24 week period.

What are the common side effects with Trelegy Ellipta?

Common side effects when Trelegy is used for COPD include: upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis (thrush), headache, back pain, joint pain, influenza (flu), sinusitis, sore throat, runny nose, altered taste, constipation, urinary tract infection, diarrhea, gastroenteritis, mouth/throat pain, cough, and voice hoarseness.

Common side effects when Trelegy is used for asthma included: common cold symptoms, headache, upper respiratory tract infection, and bronchitis.

Bottom Line

• Trelegy Ellipta (generic name: fluticasone furoate / umeclidinium / vilanterol) is an inhaler for asthma or COPD and must be used daily to be effective. It is not used as a fast-acting rescue inhaler for sudden breathing problems.
• It is used once daily to help breathing symptoms and reduce the number of asthma or COPD flare-ups over the long-term.
• Trelegy works by lowering lung inflammation and relaxing the airways in patients with either asthma or COPD.

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