Triple Therapy vs Dual Therapy for Asthma

Recruiting at 70 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Inhaled corticosteroids, Long-acting beta2-agonists

Disqualifiers: Life-threatening asthma, Active pulmonary diseases, Smoking, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

292 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable asthma medication regimen for at least 6 weeks before starting the trial.

What data supports the effectiveness of the drug FF/UMEC/VI for asthma?

The drug FF/UMEC/VI, used as a single-inhaler triple therapy, is approved for asthma management and is recommended for patients who do not respond well to dual therapy. Although the studies primarily focus on COPD, they show that the drug maintains effective levels in the body, similar to when its components are used separately or in pairs, suggesting potential effectiveness for asthma as well. ^{1 2 3 4 5}

Is the triple therapy FF/UMEC/VI safe for humans?

Research shows that the triple therapy FF/UMEC/VI has been studied for safety in people with COPD and healthy volunteers. The studies found that the drug levels in the body were similar to those seen with the individual components, suggesting it is generally safe. ^{1 2 3 4 5}

What makes the drug FF/UMEC/VI unique for asthma treatment?

The drug FF/UMEC/VI is unique for asthma treatment because it combines three medications into a single inhaler, making it easier for patients to use compared to previous options that required multiple inhalers. This single-inhaler approach can improve adherence and persistence in managing asthma. ^{1 2 3 4 6}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for 12-17 year-olds with poorly controlled asthma despite using inhaled steroids and long-acting beta agonists. They should have had a recent healthcare visit for asthma or a change in therapy, but no pneumonia or other lung diseases recently. Smokers or those with life-threatening asthma can't join.

Inclusion Criteria

My asthma is not well-controlled despite using my regular inhalers.

My lung function is between 40% and 90% of the expected level and improves with a specific inhaler.

I've seen a doctor or changed my asthma treatment due to an attack in the last year.

Exclusion Criteria

I haven't needed new asthma treatments or steroids for 3 days in the last 6 weeks.

I have not smoked or used any inhaled recreational products in the last year.

You had pneumonia shown on a chest X-ray within 6 weeks before the first visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FF/UMEC/VI or FF/VI to evaluate effects on lung function over 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FF/UMEC/VI
• FF/VI

Trial Overview The study compares the effects of two inhalers on lung function over 24 weeks: one combines Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) while the other has just FF and VI.

Participant Groups

Group I: Participants receiving FF/UMEC/VI Experimental Treatment 2 Interventions

Group II: Participants receiving FF/VI Active Control 2 Interventions

FF/UMEC/VI is already approved in United States for the following indications:

Approved in United States 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

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]

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 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 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 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 the FULFIL trial involving 1810 patients with chronic obstructive pulmonary disease (COPD), the once-daily triple therapy of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) significantly reduced the rate of moderate/severe exacerbations compared to the twice-daily dual therapy of budesonide/formoterol (BUD/FOR), especially in patients with a recent history of exacerbations.

FF/UMEC/VI also led to significant improvements in lung function and health status, demonstrating its efficacy as a treatment option for COPD regardless of the patient's exacerbation history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Recent Exacerbation History on the Efficacy of Once-Daily Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease in the FULFIL Trial. Panettieri, RA., Camargo, CA., Cheema, T., et al.[2022]

References

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

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

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. 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]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Effect of Recent Exacerbation History on the Efficacy of Once-Daily Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease in the FULFIL Trial. [2022]