Trelegy Ellipta: First Once-Daily Triple Therapy for COPD

Chronic Obstructive Pulmonary Disease, or COPD, is a progressive respiratory ailment that impacts millions of people worldwide. It causes breathing difficulties and reduced lung function and affects the overall quality of life. Managing COPD requires a diverse approach, and recent advancements in pharmaceuticals have led to novel treatments.

One such innovation is the Trelegy Ellipta inhaler, the first once-daily single inhaler triple therapy authorized by the FDA for both asthma and COPD. In this blog, we’ll delve into the significance of Trelegy Ellipta, its approval, clinical evidence that supports its efficacy, benefits for asthma and COPD, and important safety information regarding its use.

What Is Trelegy Ellipta Inhaler?

Trelegy, developed by GSK (GlaxoSmithKline), is a combination inhalation powder containing a blend of three medicines: fluticasone, umeclidinium, and vilanterol.

1. Fluticasone: It is a steroid that helps prevent the release of substances in our body that result in inflammation. By reducing airway inflammation, it plays a crucial role in treating COPD and asthma.
2. Umeclidinium: An anticholinergic, umeclidinium helps relax the muscles in the airways. By doing so, it improves breathing and reduces bronchospasms.
3. Vilanterol: It is a long-acting bronchodilator that helps soothe the muscles in the airways, making it easier to breathe.

Trelegy’s Approval as First Once-Daily Triple Therapy

Trelegy Ellipta inhaler is the first once-daily single inhaler triple therapy that received approval in the United States for treating both asthma and chronic obstructive pulmonary disease (COPD). Let’s delve into the specifics:

1. COPD Approval: Trelegy Ellipta received its initial approval in the United States as Trelegy Ellipta in September 2017. This milestone approval signified a notable achievement, as it became the inaugural once-daily single inhaler triple therapy sanctioned for the ongoing management of COPD patients.

2. Asthma Approval: On September 9, 2020, the FDA expanded the approval of Trelegy Ellipta to include asthma maintenance treatment in patients aged 18 and above. This extension broadened the range of patients who can benefit from Trelegy Ellipta, making it the sole single inhaler triple therapy available for once-daily use in the US. The FDA-approved dosage for both COPD and asthma is fluticasone furoate/umeclidinium/vilanterol 100/62.5/25mcg. Additionally, there is a specific strength for asthma treatment, which is fluticasone furoate/umeclidinium/vilanterol 200/62.5/25mcg.

Clinical Evidence

The CAPTAIN study (Clinical Study of Asthma Patients Receiving Triple Therapy through A Single Inhaler), conducted in 2019, compared Trelegy GSK to fluticasone furoate/vilanterol in COPD patients who were not effectively managed on ICS/LABA therapy. The trial involved 2,436 patients from 15 countries, with around 400 patients randomly allocated to each of the six treatment groups. Over 24 weeks, Trelegy Ellipta exhibited significant enhancements in lung function, symptom management, and overall quality of life. This pivotal study played a crucial role in obtaining approval for Trelegy Ellipta as the first once-daily single inhaler triple therapy for COPD.

Benefits for Asthma and COPD Patients

Trelegy Ellipta offers several advantages for Asthma and COPD patients:

1. Asthma

• Symptom Control: Trelegy Ellipta helps prevent and control asthma symptoms. Regular use can reduce inflammation in the airways, making breathing easier.
• Long-Term Management: It is suitable for daily use to maintain asthma control. However, it is not intended to treat sudden asthma attacks.
• Combination Therapy: The combination of fluticasone, umeclidinium, and vilanterol provides comprehensive management.

2. COPD:

• Triple Therapy in One Inhaler: Previously, patients needed multiple inhalers to manage their symptoms. Trelegy combines three essential medications into a single device, simplifying treatment regimens.
• Once-Daily Dosing: Trelegy’s once-daily administration improves adherence and convenience.
• Improved Lung Function: Clinical trials demonstrated significant improvements in lung function compared to other therapies.
• Reduced Exacerbations: Trelegy minimizes the risk of COPD exacerbations, enhancing patients’ stability and quality of life.

Important Safety Information for Trelegy Ellipta

While using Trelegy Ellipta, you should keep these safety precautions in mind:

• The risk of asthma-related death increases with long-acting beta2-adrenergic agonists (LABAs), such as vilanterol. Asthma-related deaths were higher in a placebo-controlled trial using another LABA (salmeterol). LABAs are considered to have a class effect with salmeterol.
• It has not been established whether Trelegy GSK is safe and effective in asthmatic patients. The treatment of asthma with Trelegy Ellipta is not recommended.
• Those with adverse hypersensitivity to milk proteins or any of the components should not take Trelegy Ellipta.
• It is not recommended to initiate Trelegy Ellipta in patients with acutely deteriorating COPD symptoms. Trelegy Ellipta should not be used to treat acute symptoms.
• There is a risk of overdosing with Trelegy Ellipta when combined with other medicines containing LABA.
• Several patients treated with fluticasone furoate, a component of Trelegy Ellipta, have acquired Candida albicans infection of their mouths and pharynx. Follow up with patients periodically. The patient needs to be instructed to rinse their mouth with water after inhalation without swallowing.
• When patients with COPD take Trelegy Ellipta, they are at an increased risk for pneumonia. Keep an eye out for any signs or symptoms of pneumonia in patients.
• It is possible that patients taking corticosteroids might worsen infections (e.g., tuberculosis, fungi, bacteria, viruses, parasites, or herpes simplex ocular). When treating patients with these infections, be cautious when using Trelegy Ellipta. In susceptible people, chickenpox or measles can be more severe or even fatal.
• Taking systemic corticosteroids and switching to oral corticosteroids can compromise adrenal function. If transferring patients to Trelegy Ellipta, taper them slowly off systemic corticosteroids.
• When Trelegy Ellipta is taken in very high doses or at regular doses, hypercorticism and adrenal suppression may occur. Consider appropriate therapy if such changes occur.
• Treat paradoxical bronchospasm with alternative therapy if Trelegy Ellipta triggers it.
• Because Trelegy Ellipta stimulates beta-adrenergic receptors, use it with caution in people with cardiovascular disorders.
• After prescribing Trelegy Ellipta, assess for a decrease in bone mineral density at the beginning and periodically after that.
• It is important to monitor patients carefully while taking Trelegy Ellipta for glaucoma and cataracts. Narrow-angle glaucoma can worsen. Whenever symptoms of narrow-angle glaucoma occur, patients should immediately contact a healthcare provider.
• When taking Trelegy Ellipta, patients may experience worsening urinary retention. Instruct patients to call a healthcare provider immediately if symptoms occur if they have prostatic hyperplasia or urinary neck obstruction.
• If you have convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis, or diabetes mellitus, use Trelegy GSK with caution.
• Patients taking Trelegy Ellipta should be alert to hypokalemia and hyperglycemia.
• Trelegy Ellipta has been reported to cause headaches, back pain, dysgeusia, diarrhea, coughing, oropharyngeal pain, and gastroenteritis in 1% of cases.

Following these recommendations is crucial for the safe and effective use of the Trelegy Ellipta inhaler. In addition, if you want to buy Trelegy online, the best Canadian online pharmacy, Polar Bear Meds, offers discounted prices and timely delivery.

The Takeaway

Trelegy Ellipta inhaler is the first once-daily single inhaler triple therapy that revolutionizes COPD and asthma treatment. Combining fluticasone, umeclidinium, and vilanterol, it offers improved lung function and respiratory symptom control. FDA-approved for both conditions, Trelegy simplifies treatment regimens, reduces exacerbations, and enhances patient adherence. Clinical evidence from the CAPTAIN study supports its efficacy in COPD, while safety information highlights precautions for use. Trelegy GSK represents a significant advancement in respiratory care, providing comprehensive management and convenience for patients with chronic respiratory conditions.