Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol) - 2 indications

Scroll down for more information on each indication:

• the maintenance treatment of chronic obstructive pulmonary disease in adults; approved September 2017 
• for the maintenance treatment of asthma in adults; approved September 2020

General Information

Trelegy Ellipta is a combination of fluticasone furoate - an inhaled corticosteroid (ICS), umeclidinium - an anticholinergic, and vilanterol-  a long-acting beta2-adrenergic agonist (LABA).

Trelegy Ellipta is specifically indicated for 

• the maintenance treatment of patients with chronic obstructive pulmonary disease
• the maintenance treatment of asthma in patients aged 18 years and older

Trelegy Ellipta is supplied as a powder for oral inhalation. Administer 1 actuation of Trelegy Ellipta once daily by oral inhalation. After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Trelegy Ellipta should be used at the same time every day. Do not use Trelegy Ellipta more than 1 time every 24 hours. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment.

Scroll down for the recommended dosing/administration for each indication

Mechanism of Action

Trelegy Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA).

Side Effects

Adverse effects associated with the use of Trelegy Ellipta for COPD may include, but are not limited to, the following:

• upper respiratory tract infection
• pneumonia
• bronchitis
• oral candidiasis
• headache
• back pain
• arthralgia
• influenza
• sinusitis
• pharyngitis
• rhinitis
• dysgeusia
• constipation
• urinary tract infection
• diarrhea
• gastroenteritis
• oropharyngeal pain
• cough
• dysphonia

Adverse effects associated with the use of Trelegy Ellipta for asthma may include, but are not limited to, the following:

• pharyngitis/nasopharyngitis
• upper respiratory tract infection/viral upper respiratory tract infection
• bronchitis
• respiratory tract infection/viral respiratory tract infection
• sinusitis/acute sinusitis
• urinary tract infection
• rhinitis
• influenza
• headache
• back pain

Indication 1 - the maintenance treatment of chronic obstructive pulmonary disease in adults

approved September 2017 

Dosing/Administration

The recommended dosage of Trelegy Ellipta for maintenance treatment of COPD is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) once daily by oral inhalation. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Clinical Trial Results

The FDA approval of Trelegy Ellipta for COPD was based on 3 clinical trials in subjects with COPD, including chronic bronchitis and/or emphysema: Trial 1, Trial 2 and Trial 3. 

Trials 1 and 2 were multicenter, randomized, double-blind, parallel-group, 12-week treatment trials in subjects with COPD. Across both trials, a total of 412 subjects received co-administration of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg, the components of Trelegy Ellipta. In Trials 1 and 2, the primary endpoint was change from baseline in trough (predose) FEV1 at Day 85 (defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous dose on Day 84). For both COPD trials, umeclidinium + fluticasone furoate/vilanterol demonstrated a statistically significant increase relative to placebo + fluticasone furoate/vilanterol. Similar results were demonstrated for the secondary endpoint of the weighted mean FEV1 (0 to 6 hours post-dose) on Day 84.

Trial 3 was a randomized, multicenter, double-blind, parallel-group, 52-week treatment trial comparing the clinical efficacy of Trelegy Ellipta 100/62.5/25 mcg with the fixed-dose combinations of fluticasone furoate/vilanterol 100/25 mcg and umeclidinium/vilanterol 62.5/25 mcg. A total of 10,355 subjects with COPD with a history of 1 or more moderate or severe exacerbations in the prior 12 months were randomized (2:2:1) to receive Trelegy Ellipta, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily. In Trial 3, treatment with Trelegy Ellipta 100/62.5/25 mcg demonstrated a statistically significant improvement in lung function (mean change from baseline trough FEV1 at Week 52) compared with fluticasone furoate/vilanterol and umeclidinium/vilanterol. The mean change from baseline in trough (predose) FEV1 at Week 52 was 97 mL for Trelegy Ellipta compared with fluticasone furoate/vilanterol and 54 mL for Trelegy Ellipta compared with umeclidinium/vilanterol. The effects on lung function (mean change from baseline trough FEV1) of Trelegy Ellipta compared with fluticasone furoate/vilanterol and umeclidinium/vilanterol were observed at all timepoints over the course of the 52-week study. 

Indication 2 - for the maintenance treatment of asthma in adults

approved September 2020

Dosing/Administration

The recommended starting dosage of Trelegy Ellipta for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of Trelegy Ellipta 200/62.5/25 mcg) once daily, by oral inhalation. When choosing the starting dosage strength of Trelegy Ellipta, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation. The maximum recommended dosage is 1 inhalation of Trelegy Ellipta 200/62.5/25 mcg once daily. For patients who do not respond adequately to Trelegy Ellipta 100/62.5/25 mcg once daily, increasing the dose to Trelegy Ellipta 200/62.5/25 mcg once daily may provide additional improvement in asthma control. For patients who do not respond adequately to Trelegy Ellipta 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Clinical Trial Results

The FDA approval of Trelegy Ellipta for the treatment of asthma in patients aged 18 years and older was based on the the CAPTAIN trial. CAPTAIN evaluated in 2,436 subjects in a randomized, double-blind, parallel-group, active-controlled confirmatory trial of 24 to 52 weeks’ duration in adult subjects with asthma inadequately controlled on their current treatments of combination therapy (ICS plus a LABA). The primary efficacy endpoint was change from baseline in trough FEV1 at Week 24. Both Trelegy Ellipta 100/62.5/25 mcg and Trelegy Ellipta 200/62.5/25 mcg showed statistically significant improvements in lung function compared with 40 fluticasone furoate/vilanterol 100/25 mcg and fluticasone furoate/vilanterol 200/25 mcg, respectively.