Status:
COMPLETED
Efficacy and Safety of GSK3923868 Inhalation Powder, During Experimental Human Rhinovirus Infection in Participants With Mild Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05398198
Start Date
June 9 2022
End Date
April 9 2024
Last Update
May 6 2024
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, E1 2AX