Triple Therapy vs Dual Therapy for Asthma

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: GlaxoSmithKline

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

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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}

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.

Trial 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 (Corticosteroid/Anticholinergic/Beta2-agonist Combination)
• FF/VI (Corticosteroid/Beta2-agonist Combination)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

GSK Investigational Site North Charleston, SC

GSK Investigational Site Miami Lakes, FL

GSK Investigational Site Colorado Springs, CO

GSK Investigational Site Mission Viejo, CA

More Trial Locations

Who Is Running the Clinical Trial?

GlaxoSmithKline Lead Sponsor

References

1. 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 &#946;2-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.

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. 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.

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] 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).

5. 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.

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] In the FULFIL trial, once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) resulted in reduced moderate/severe exacerbation rates and conferred significant improvements in lung function and health status in patients with chronic obstructive pulmonary disease (COPD) versus twice-daily budesonide/formoterol (BUD/FOR) dual therapy.