370 Participants NeededMy employer runs this trial

GSK5784283 for Asthma

Recruiting at 5 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: GlaxoSmithKline
Must be taking: Inhaled corticosteroids, Asthma controllers
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GSK5784283, an experimental therapy, to determine if it reduces asthma attacks compared to a placebo, which contains no active drug. The goal is to assess whether this treatment decreases the number of significant asthma flare-ups. It targets individuals who have had asthma for at least a year, experience frequent asthma attacks, and require regular medication to manage their symptoms. Participants will receive either the new treatment or a placebo, in addition to their usual asthma care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new asthma treatment.

Is there any evidence suggesting that GSK5784283 is likely to be safe for humans?

Research has shown that GSK5784283 is being tested as a treatment for asthma and appears safe. In earlier studies, this drug helped manage asthma symptoms over a year. These studies examined major asthma flare-ups and participants' tolerance of the treatment.

The results did not reveal any major safety issues with GSK5784283, suggesting it is generally well-tolerated by people with asthma. However, joining any clinical trial may involve unknown risks. Always consult a healthcare provider to fully understand the safety and possible side effects.12345

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments like inhaled corticosteroids and bronchodilators, GSK5784283 acts on different pathways to manage asthma symptoms. Researchers are excited about this treatment because it targets specific immune responses that traditional therapies might not address, potentially offering relief to patients who don't respond well to current options. This innovative approach could pave the way for more personalized asthma care, providing hope for better management of the condition.

What evidence suggests that GSK5784283 might be an effective treatment for asthma?

Research has shown that the asthma treatment GSK5784283, which participants in this trial may receive, can significantly reduce asthma attacks. In earlier studies, this treatment decreased asthma flare-ups by 54% over a year compared to a placebo and led to fewer hospital or emergency room visits. However, patient feedback was mixed. Overall, the evidence suggests it could be very helpful for people with uncontrolled asthma.678910

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people aged 12 to 80 who have had asthma diagnosed by a doctor for at least a year, have had an asthma flare-up in the past year, and show signs of variable airflow. Women able to get pregnant must use reliable birth control and test negative for pregnancy before each dose.

Inclusion Criteria

I am between 12 and 80 years old.
If urine pregnancy test is ambiguous, a serum test is required; positive serum test excludes participation
POCBP participants must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test within 24 hours before each dose
See 10 more

Exclusion Criteria

Other significant medical conditions impacting safety or study outcomes
Current smokers of tobacco or marijuana, current users of vaping/e-cigarettes, or smoking history of 10 or more pack-years
I have not had a recent heart attack, stroke, or serious heart rhythm problem.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK5784283 or placebo as an add-on therapy to standard care for uncontrolled asthma

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GSK5784283

Trial Overview

The study compares GSK5784283 (a new treatment) with placebo, both given alongside standard asthma care. Participants are randomly assigned to receive either the new drug or placebo to see if GSK5784283 reduces serious asthma attacks better than placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving GSK5784283 plus standard of careExperimental Treatment2 Interventions
Group II: Participants receiving matching placebo plus standard of carePlacebo Group2 Interventions

Find a Clinic Near You

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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

Gsk5784283 clinical trials - Research.Patient.info

This study is looking for the right dose of a new medicine, GSK5784283, for adults aged 18 to 75 with asthma that isn't fully controlled by their current ...

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However, its treatment benefit measured by patient-reported outcomes (PROs) has been inconsistent across asthma-specific PRO endpoints.

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The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

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Pipeline assets and clinical trials appendix - Q1 2025

asthma control and safety in adult and adolescent severe asthmatic ... GSK5784283 (Asthma). NCT06748053. Phase. II. Patient. Adults aged 18 to 75 years of age ...

Pipeline assets and clinical trials appendix

measures of asthma control and safety in adult and adolescent severe asthmatic ・ alised rate of clinically significant exacerbations over 52 weeks. GSK5784283 ...

Pipeline

Respiratory, immunology and inflammation Asthma, GSK5784283 † Respiratory, immunology and inflammation Asthma, low carbon version of metered ...