Triple Therapy for Uncontrolled Asthma

Recruiting at 79 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: GlaxoSmithKline

Must be taking: ICS, ICS/LABA

Must not be taking: Biologics, LAMA, RELVAR, ARNUITY

Disqualifiers: Life-threatening asthma, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1358 Participants Needed

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.

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 inhaled corticosteroids/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}

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}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either FF/UMEC/VI or ICS/LABA for asthma management

52 weeks

Regular visits as per study protocol

Primary Analysis

Primary analysis of treatment effectiveness at 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
• Inhaled corticosteroids/long-acting beta-2 agonists

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

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

The study assessed the pharmacokinetics and safety of a single inhaler containing fluticasone furoate, umeclidinium, and vilanterol in healthy Chinese adults, showing expected drug exposure levels after both single and repeated doses over a week.

No new safety concerns were identified, indicating that the triple therapy is safe for use in this population, with pharmacokinetic parameters aligning with previously reported data for the individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults. Li, Y., Li, H., Sheng, Y., et al.[2020]

A population pharmacokinetic analysis of 74 patients with COPD showed that the combined inhaler of fluticasone furoate, umeclidinium, and vilanterol delivers drug concentrations similar to those seen with individual or dual therapies, indicating effective absorption and distribution.

The study, part of a 24-week trial comparing triple therapy to dual therapy, suggests that the once-daily triple therapy is pharmacokinetically comparable to existing treatments, supporting its potential efficacy in managing COPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium/Vilanterol via a Single Inhaler in Patients with COPD. Mehta, R., Pefani, E., Beerahee, M., et al.[2019]

In two studies involving 88 healthy volunteers, the closed triple therapy of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) showed similar systemic exposure to its components compared to dual therapies, indicating effective delivery of the medication.

The safety profile was favorable, with a low incidence of adverse events across all treatment groups, suggesting that the triple therapy can be safely administered without significant systemic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers. Brealey, N., Gupta, A., Renaux, J., et al.[2019]

In a 6-year observational study involving 3426 patients with asthma and/or COPD, fluticasone furoate/vilanterol (FF/VI) demonstrated a good safety profile, with an overall adverse event rate of 30.9% and serious adverse events occurring in only 4.1% of patients.

FF/VI was effective in improving lung function, with significant increases in forced expiratory volume in 1 second (FEV1) observed in patients with asthma (0.09 L), COPD (0.11 L), and those with both conditions (0.05 L), indicating its efficacy in real-world settings.

NCBI (Pubmed)

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. Cho, EY., Cho, JE., Jang, SH., et al.[2023]

In a study of 22,177 COPD patients, most users of the single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and multiple-inhaler triple therapy (MITT) had experienced moderate to severe exacerbations or were already on maintenance therapy before starting treatment, indicating a need for more effective management of their condition.

The study found that a significant portion of FF/UMEC/VI users (41.2%) had previously used overlapping inhaler therapies, suggesting that patients often transition to this therapy after inadequate control with existing medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease. Wu, B., Mannino, D., Mu, G., et al.[2022]

In the 52-week IMPACT study involving 7012 patients with chronic obstructive pulmonary disease (COPD), single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) showed similar cardiovascular (CV) safety compared to dual therapies (FF/VI and UMEC/VI), with CV adverse events occurring in 10-11% of patients across all treatment groups.

There was no statistically significant increase in cardiovascular risk associated with FF/UMEC/VI compared to the other therapies, indicating that this triple therapy is safe for patients with COPD who have a high prevalence of cardiovascular disease.

NCBI (Pubmed)

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. Day, NC., Kumar, S., Criner, G., et al.[2021]

In a study of 6,511 patients, those using the single-inhaler triple therapy FF/UMEC/VI showed significantly better adherence to their medication compared to those using multiple inhalers, with a mean proportion of days covered of 0.68 versus 0.59.

Patients on FF/UMEC/VI were also 49% more likely to continue their treatment after 12 months compared to those on multiple-inhaler therapy, indicating that the single-inhaler option may improve long-term treatment persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence and Persistence to Single-Inhaler Versus Multiple-Inhaler Triple Therapy for Asthma Management. Busse, WW., Abbott, CB., Germain, G., et al.[2022]

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]

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

Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium/Vilanterol via a Single Inhaler in Patients with COPD. [2019]

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

Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers. [2019]

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]

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]

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]

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

Adherence and Persistence to Single-Inhaler Versus Multiple-Inhaler Triple Therapy for Asthma Management. [2022]