Triple Therapy for Uncontrolled Asthma

Recruiting in Palo Alto (17 mi)

+79 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: GlaxoSmithKline

Must be taking: ICS, ICS/LABA

Must not be taking: Biologics, LAMA, others

Disqualifiers: Life-threatening asthma, COPD, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it seems you can continue if you are on daily maintenance inhaled corticosteroids or a combination of inhaled corticosteroids and long-acting beta-2 agonists. However, if you are using certain medications like RELVAR ELLIPTA or ARNUITY ELLIPTA, you cannot participate.

Is the triple therapy of Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate generally safe for humans?

Studies have shown that the triple therapy of Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate is generally safe in humans, with no new safety concerns observed in both healthy adults and patients with chronic obstructive pulmonary disease (COPD). ^{1 2 3 4 5}

How is the drug Trelegy Ellipta different from other asthma treatments?

Trelegy Ellipta is unique because it combines three medications (fluticasone furoate, umeclidinium, and vilanterol) into a single inhaler, making it more convenient for patients who previously needed multiple inhalers for triple therapy. This single-inhaler approach can improve adherence and persistence in managing uncontrolled asthma. ^{2 3 5 6 7}

Eligibility Criteria

Adults with uncontrolled asthma are eligible for this trial. Specific details about inclusion and exclusion criteria were not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

ACQ-6 score ≥1.5 at randomization

Participants must be able to complete the study questionnaires

I am currently using daily asthma medication, either alone or with a LABA.

Exclusion Criteria

Women of childbearing potential not following at least one highly effective method of contraception

I am currently taking RELVAR ELLIPTA and ARNUITY ELLIPTA.

I am currently on or have recently used biologic therapy.

Treatment Details

Interventions

• Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (Combination Therapy)
• Inhaled corticosteroids/long-acting beta-2 agonists (Corticosteroid)

Trial Overview The trial is testing the effectiveness of a combination inhaler (FF/UMEC/VI) against usual care inhaled corticosteroids plus long-acting beta-2 agonists (ICS/LABA). It's an open-label, randomized study where patients are assigned to treatments by chance.

Participant Groups

Group I: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) Experimental Treatment 1 Intervention

Group II: Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) Active Control 1 Intervention

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Trelegy Ellipta for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma

🇪🇺 Approved in European Union as Trelegy Ellipta for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

GSK Investigational Site Tallahassee, FL

GSK Investigational Site Kerrville, TX

GSK Investigational Site Little Rock, AR

GSK Investigational Site Brick, NJ

More Trial Locations

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults. [2020] The pharmacokinetics (PK) and safety of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) after single and repeat dosing in healthy Chinese adults were assessed. In this open-label study (NCT02837380), subjects received once-daily FF/UMEC/VI 100/62.5/25 µg on day 1 and repeat doses on days 2-7. PK parameters (days 1 and 7) included maximum observed concentration (Cmax ) and area under the plasma concentration-time curve (AUC) from time zero (predose) to last time of quantifiable concentration (AUC0-t ). Terminal phase half-life (t½ ) on day 1 was estimated. The primary objective was to assess systemic exposure of FF 100 µg, UMEC 62.5 µg, and VI 25 µg following single-inhaler triple therapy on days 1 and 7. On day 1, geometric mean t½ of UMEC and VI was 0.36 and 0.52 hours, respectively; t½ of FF was not representative because of nonquantifiable concentration data. On days 1 and 7, geometric mean Cmax of FF was 10.46 and 27.32 pg/mL, respectively; Cmax of UMEC was 144.14 and 241.35 pg/mL, respectively; and Cmax of VI was 120.42 and 196.78 pg/mL, respectively. AUC0-t of FF was 1.77 and 276.96 pg·h/mL, respectively; AUC0-t of UMEC was 28.44 and 117.19 pg·h/mL, respectively; and AUC0-t of VI, 42.46 and 101.12 pg·h/mL, respectively. The PK of FF/UMEC/VI was as expected for the individual-component PK previously reported in healthy Chinese adults. No new safety signals were observed.

2. England pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium/Vilanterol via a Single Inhaler in Patients with COPD. [2019] A population pharmacokinetic analysis was conducted from a subset of samples obtained from the Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy trial to characterize the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol in patients with symptomatic COPD following treatment with fluticason furoate-umeclidinium-vilanterol combined in a single inhaler. This was a randomized, double-blind, double-dummy study comparing 24 weeks of once-daily triple therapy (fluticason furoate-umeclidinium-vilanterol, 100 μg/62.5 μg/25 μg; Ellipta inhaler) with twice-daily dual therapy (budesonide/formoterol 400 μg/12 μg; Turbuhaler). The analyses were conducted in a subset of 74 patients who received fluticason furoate-umeclidinium-vilanterol and provided serial or sparse samples. Monte Carlo simulations and a model-based estimation approach both indicated that systemic drug concentrations of fluticasone furoate, umeclidinium, and vilanterol after administration of fluticason furoate-umeclidinium-vilanterol triple combination therapy from a single inhaler were within the ranges observed following administration of these drugs as monotherapy (fluticasone furoate, umeclidinium, and vilanterol) or as dual-combination therapy (fluticasone furoate/vilanterol or umeclidinium/vilanterol).

3. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers. [2019] Two single-center, four-way, single-dose, crossover studies assessed the systemic exposure, systemic pharmacodynamics (PD), and safety profile of the closed triple fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) therapy compared with dual therapies. These are the first studies where pharmacokinetic (PK) profile assessment was possible for this inhaled triple fixed-dose combination product.

4. New Zealand pubmed.ncbi.nlm.nih.gov

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea. [2023] Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period.

5. United States pubmed.ncbi.nlm.nih.gov

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease. [2022] Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT).

6. England pubmed.ncbi.nlm.nih.gov

Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. [2021] This analysis of the IMPACT study assessed the cardiovascular (CV) safety of single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI dual therapy.

7. United States pubmed.ncbi.nlm.nih.gov

Adherence and Persistence to Single-Inhaler Versus Multiple-Inhaler Triple Therapy for Asthma Management. [2022] Label="BACKGROUND">Treatment guidelines recommend triple therapy for patients with asthma who remain uncontrolled on inhaled corticosteroid/long-acting β2-agonist therapy. Previously, triple therapy was only available via multiple inhalers. Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is approved as maintenance treatment for asthma; however, real-world information on adherence and persistence is limited.