• Trelegy Ellipta and Breo Ellipta are both orally inhaled maintenance (long-term) treatments for either asthma or COPD (including chronic bronchitis, emphysema, or both).
• Trelegy Ellipta contains three long-acting medications: fluticasone, an inhaled corticosteroid, vilanterol, a long-acting beta-agonist (LABA), and umeclidinium, an anticholinergic drug. Breo Ellipta contains only two of these medications: fluticasone and vilanterol. You should use either Trelegy or Breo, but not both.
• These medicines are used once daily to help breathing symptoms and reduce the number of flare-ups by lowering lung inflammation and relaxing the airways in patients with either asthma or COPD. They are not used to control sudden breathing problems.

Trelegy Ellipta is an orally inhaled medicine approved by the FDA as a maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD) in adults. Trelegy Ellipta is inhaled once per day and contains 3 medications:

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

Breo Ellipta is also an inhaled medicine used for the once-daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults. However, Breo Ellipta only contains two medicines (also found in Trelegy):

• the corticosteroid fluticasone
• the long-acting beta-agonist (LABA) vilanterol
• Breo Ellipta does not contain the anticholinergic bronchodilator umeclidinium.

Are the doses the same for Trelegy and Ellipta?

Do not use both Breo Ellipta and Trelegy Ellipta to treat your asthma or COPD. Only use one drug or the other as prescribed by your doctor. Follow your doctor’s instructions exactly.

Do not use other medicines that contain a long-acting beta-agonist (LABA) or an anticholinergic for any reason. Ask your health care provider or pharmacist if any of your other medicines contain LABA or anticholinergic medicines.

Neither of these drugs should be used as a fast-acting (rescue) inhaler for the relief of sudden breathing problems.

Neither Trelegy or Breo are approved for use in children.

Trelegy dosing

• One dose of Trelegy for asthma or COPD contains 100 micrograms (mcg) of fluticasone, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol. This once-daily dosage can be used for both asthma and COPD.
• A higher dose of Trelegy is also available for asthma only; it contains 200 micrograms (mcg) of fluticasone, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol, also given once daily, at the same time every day.
• Do not use Trelegy more than 1 time every 24 hours.

Breo dosing

• One dose of Breo for asthma or COPD contains 100 micrograms (mcg) of fluticasone furoate and 25 mcg of vilanterol. This once-daily dosage can be used for both asthma and COPD. Breo does not contain the anticholinergic bronchodilator umeclidinium.
• A higher dose of Breo is also available for asthma only; it contains 200 micrograms (mcg) of fluticasone furoate and 25 mcg of vilanterol, and is also given once daily, at the same time every day.
• Do not use Breo more than 1 time every 24 hours.

After inhalation of either Trelegy or Breo, you should rinse your mouth with water (without swallowing) to lower the risk of developing oral thrush, a type of fungal infection.

Which is better - Trelegy or Breo ?

Both drugs have been shown to be effective for the treatment of asthma or COPD in controlled clinical studies. However, some patients may need to move up to triple therapy for long-term control of their breathing symptoms or flare-ups. In the past, this often involved the use of two separate inhalers.

• Now, for those patients who are not adequately controlled by using the two medicines found in Breo Ellipta, Trelegy Ellipta may offer an advantage as it also contains umeclidinium, an anticholinergic bronchodilator in one inhaler.
• This means you may only need one inhaler instead of two, which may be more convenient.
• Trelegy is the first FDA-approved, single inhaler, triple therapy for once-daily maintenance treatment of both asthma and COPD in the U.S.

Trelegy and Breo studies

COPD
Trelegy Ellipta and Breo Ellipta were both compared in a study evaluating over 10,000 patients being treated for COPD. In this study, called the IMPACT study, the main endpoint researchers were looking at was the annual rate of moderate to severe exacerbations ("flare-ups") in patients with COPD.

• The results showed that Trelegy was more effective for reducing flare-ups and improving lung function compared to the two medicines in Breo. Trelegy reduced flare-ups by 15% compared to Breo over one-year, a significant effect.
• The results also showed that patients who took Trelegy Ellipta could breathe out significantly more air in one second compared to those who took Breo Ellipta, which is known as the forced expiratory volume in one second (FEV1). This improved lung function was sustained over the one year period.
• Based on a survey, Trelegy also improved these patient’s health-related quality of life when compared to Breo, which included items such as daily symptoms, daily activities and perceived well-being.

Asthma
In the CAPTAIN study in over 2,400 patients with asthma, Trelegy Ellipta led to an improvement in lung function when compared to Breo using two different strengths of Trelegy: 100/62.5/25 mcg and 200/ 62.5/25 mcg.

• 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 over a 24 week period.
• 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.

Your results can vary as each person’s condition is unique. Your doctor can evaluate your symptoms and determine which treatment may be the best option for you.

Can I use Trelegy or Breo for sudden breathing problems?

No. Neither drug is a rescue medicine for bronchospasm attacks and sudden breathing problems. Use only your fast-acting inhalation medicine (for example, albuterol or levalbuterol) for sudden symptoms.

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.

Do not take Trelegy or Breo with other medicines that contain a long-acting beta2-adrenergic agonist (LABA) or an anticholinergic for any reason.

Are side effects similar between Trelegy and Breo?

Trelegy contains fluticasone, vilanterol and umeclidinium, while Breo contains only fluticasone and vilanterol. Because Trelegy contains an extra medicine, some side effects may differ between the two drugs.

Examples of similar side effects seen with the use of Trelegy Ellipta or Breo Ellipta include:

• upper respiratory tract infection
• pneumonia
• flu
• bronchitis
• thrush fungal infections (oral candidiasis)
• headache
• back or joint pain
• swelling of the sinuses
• runny nose, sore throat, cough
• upset stomach and diarrhea
• mouth and/or throat pain
• hoarse voice

Additional common side effects you may experience with Trelegy that were not reported with Breo include:

• taste disturbance
• constipation,
• urinary tract infection

Additional common side effects you may experience with Breo that were not reported with Trelegy include:

• increased blood pressure
• fever.

These are not all of the common or serious side effects that can occur with Trelegy Ellipta or Breo Ellipta. See their individual package inserts to review more side effects (in detail), or ask your doctor or pharmacist.

How do Trelegy and Breo come from the pharmacy?

Both Trelegy Ellipta and Breo Ellipta come as dry powder oral inhalers that you use once a day. You breathe the medicine into your lungs. Your doctor, nurse or pharmacist can show you how to use your inhaler. Do not use both of these medicines to treat your asthma or COPD.

These inhalers come with foil strips that contain the medicine. You place the foil strips into the inhaler before you breathe in the medicine.

• For Trelegy, one strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 and 25 mcg per blister, respectively). A blister from each strip is used to create 1 dose.
• For Breo, one strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose.

Which costs more - Trelegy or Breo?

The cost of medications can vary based on your insurance type, coverage, copays, pharmacy and location.

• The cost for a one month supply of Breo Ellipta, which contains two medicines, is around $380.
• The cost for a one month supply of Trelegy Ellipta, which contains three medicines, is around $600.
• No generic alternatives are available for either Trelegy or Breo at this time.

These are expensive medications. If your insurance does not cover these medications, you may be able to receive help for your prescription costs from GlaxoSmithKline (GSK), the manufacturer of these medicines.

In addition, online coupons and discount cards are available that may lower your price if you are paying cash.

If you are still having trouble with the cost of this medicine, contact your doctor to determine if there are other, more affordable options available to treat your asthma or COPD.

Bottom Line

• Trelegy Ellipta and Breo Ellipta are oral inhalers for the long-term treatment of asthma or COPD. They are not used for sudden breathing problems. Do not use both of these medicines; use one or the other as prescribed by your doctor.
• Common side effects that occur with both Trelegy and Breo include respiratory tract infections, oral thrush, headache and sore throat. Other side effects may occur.
• Neither Trelegy or Breo are available in a generic at this time. These medications are expensive but may be covered by your insurance. The manufacturer of both of these drugs, GlaxoSmithKline (GSK), may be able to help you with the cost of your medicine.

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