Efficacy and Safety of GSK3923868 Inhalation Powder, During Experimental Human Rhinovirus Infection in Participants With Mild Asthma

NCT ID: NCT05398198

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2024-04-09

Brief Summary

This is a Phase 1b, single center study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3923868 following repeat doses in mild asthmatics during experimental human rhinovirus 16 (HRV-16) infection. The study will be conducted in two parts. Part A will determine the efficacy of GSK3923868 administration after viral inoculation (i.e., therapeutic treatment) and Part B may be undertaken to determine the efficacy of GSK3923868 administration before viral inoculation (i.e., prophylactic treatment). The purpose of this study is to establish proof-of-mechanism that GSK3923868 treatment can reduce symptoms of Human Rhinovirus (HRV) infection in a controlled setting.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GSK3923868

All participants in this arm will receive GSK3923868

Group Type: EXPERIMENTAL

GSK3923868

Intervention Type: DRUG

GSK3923868 dose and administration as per study intervention.

Placebo

All participants in this arm will receive matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching GSK3923868 will be administered.

Interventions

GSK3923868

GSK3923868 dose and administration as per study intervention.

Intervention Type: DRUG

Placebo

Placebo matching GSK3923868 will be administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All Participant aged between 18 to 65 years of age (inclusive).
• Participants with a diagnosis of asthma.
• A screening pre-bronchodilator FEV1 greater than or equal to (≥) 65 percentage (%) predicted normal value.
• Positive Methacholine challenge test, defined as ≥ 20% fall in FEV1 at a methacholine concentration less than or equal to (≤) 16 milligram/milliliter (mg/mL) at Screening.

If the methacholine challenge test is negative or the participant is unable to perform this test, bronchodilator reversibility is allowed as an alternative, assessed as follows:

• Positive bronchodilator reversibility test, defined as an increase in FEV1 >12% and >200 mL from baseline, 10 to 15 minutes after administration of 400 micrograms (mcg) salbutamol (or equivalent).
• Participants with positive skin prick test.
• The HRV-16 neutralization antibody assay indicates that the participant will be susceptible to HRV-16 infection.
• Participants with controlled asthma, using short-acting beta agonist (SABA) or intermittent inhaled corticosteroid (ICS) or ICS/ long-acting beta agonist (LABA) therapy.
• Male and female- A female participant is eligible to participate if she is not pregnant or breastfeeding.
• Participant capable of giving signed informed consent.

Exclusion Criteria

All participants:

• Any asthma exacerbation requiring systemic corticosteroids within 8 weeks of admission, or that resulted in overnight hospitalization requiring additional treatment for asthma within 3 months of admission.
• History of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit.
• The presence of concurrent significant pulmonary diseases, other than asthma, including bronchiectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other significant respiratory abnormalities.
• Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the study.
• Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of admission and/or history of being hospitalized due to epistaxis on any previous occasion.
• Any nasal or sinus surgery within 3 months of admission with any acute illness, including a common cold or other respiratory tract infection within 6 weeks before admission.
• Any major illness or hospitalization within 6 months before admission to the unit.
• Lifetime history of anaphylaxis or severe allergic reaction or significant intolerance to any food or drug.
• Fridericia's QT correction formula (QTcF) >450 millisecond (msec) on Day -1 based on the average of triplicate ECGs.
• Evidence of vaccinations within the 4 weeks prior to the planned date of viral challenge.
• Intention to receive any vaccination before the last day of follow up.
• Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months.
• Positive pathogen screen for respiratory tract infection
• History of regular use of tobacco or nicotine-containing products.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2021-006640-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

213499

Identifier Type: -

Identifier Source: org_study_id