Pulmonary Disease, Chronic ObstructivePhase 1NCT05398198
Efficacy and Safety of GSK3923868 Inhalation Powder, During Experimental Human Rhinovirus Infection in Participants With Mild Asthma
A Phase 1 study testing GSK3923868 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK3923868
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jun 2022to 9 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Repeat Dose Phase 1b Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GSK3923868 During Experimental Human Rhinovirus Infection in Participants With Mild Asthma
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
- Being tested
- GSK3923868, Placebo
- Keywords
- GSK3923868, Chronic Obstructive Pulmonary Disease (COPD), Respiratory Tract Diseases, Respiration Disorders, Pharmacokinetics, Pharmacodynamics, Human Rhinovirus (HRV), Viral Challenge
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3923868Drug
GSK3923868 dose and administration as per study intervention.
PlaceboDrug
Placebo matching GSK3923868 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3923868 | Experimental | All participants in this arm will receive GSK3923868 Receives: Drug: GSK3923868 |
| Placebo | Placebo comparator | All participants in this arm will receive matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of change from baseline (CfB) in total lower respiratory tract symptoms (LRTS) score from day of inoculation up to discharge
The LRTS includes cough, chest tightness, shortness of breath, wheezing, daily activity, and night time awakenings. Each symptom is assessed on a 4-point scale. The score ranges from 0 to 3, where higher points indicate more symptoms experienced and severity that restricts normal activities. Shortness of breath and wheezing will be measured on a 5-point scale and ranges from 0 to 4 in which 0 indicates no symptoms and 4 indicates symptoms at total rest and the highest level of disease severity. LRTS assessment is performed three times a day.
Measured: Baseline and up to Day 15
Secondary outcomes (8)
Maximal CfB in total LRTS score from day of inoculation up to discharge
Measured: Baseline and up to Day 15
AUC and maximal CfB in total upper respiratory tract symptoms (URTS) score from day of inoculation up to discharge
The URTS includes nasal discharge, nasal obstruction, sneezing and sore throat. Each symptom will be assessed on a 4-point scale, where 0 indicates no symptom and a higher point for more symptoms and severity that restricts normal activities.
Measured: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in trough force expiratory volume (FEV1) from day of inoculation up to discharge
Measured: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in morning and evening peak expiratory flow (PEF) from day of inoculation up to discharge
Measured: Baseline and up to Day 15
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 22
Number of participants with clinically significant changes in vital signs
Measured: Up to Day 22
Number of participants with clinically significant changes in electrocardiogram (ECG)
Measured: Up to Day 22
Number of participants with clinically significant changes in clinical laboratory parameters
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start9 Jun 2022
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: In therapeutic treatment cohorts (cohort 1 and 2) repeat doses of GSK3923868 are administered after experimental viral infection with increasing time windows between viral inoculation and the initiation of study drug. The treatment is initiated 2, 3 and 4 days post-viral inoculation for cohort 1 and 2. Part B: In prophylactic treatment cohort (cohort 3), treatment is initiated before inoculation with virus. Of 3 cohorts planned, two cohorts will be performed (Cohort 1 and either Cohort 2 or 3). Cohort 1 data will be used to determine which cohort to progress to along with any study design changes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398198
- Sponsor's protocol ID
- 213499
- Other IDs
- 2021-006640-27
- Status last verified
- May 2024
- First submitted
- 26 May 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Repeat Dose Phase 1b Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GSK3923868 During Experimental Human Rhinovirus Infection in Participants With Mild Asthma
- ClinicalTrials.gov ID
- NCT05398198
- Acronym / sponsor ID
- 213499
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GSK3923868, Chronic Obstructive Pulmonary Disease (COPD), Respiratory Tract Diseases, Respiration Disorders, Pharmacokinetics, Pharmacodynamics, Human Rhinovirus (HRV), Viral Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A: In therapeutic treatment cohorts (cohort 1 and 2) repeat doses of GSK3923868 are administered after experimental viral infection with increasing time windows between viral inoculation and the initiation of study drug. The treatment is initiated 2, 3 and 4 days post-viral inoculation for cohort 1 and 2. Part B: In prophylactic treatment cohort (cohort 3), treatment is initiated before inoculation with virus. Of 3 cohorts planned, two cohorts will be performed (Cohort 1 and either Cohort 2 or 3). Cohort 1 data will be used to determine which cohort to progress to along with any study design changes.
| Arm | Type | Receives |
|---|---|---|
| GSK3923868 | Experimental | Drug: GSK3923868All participants in this arm will receive GSK3923868 |
| Placebo | Placebo comparator | Drug: PlaceboAll participants in this arm will receive matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3923868GSK3923868 dose and administration as per study intervention. | Drug | GSK3923868 |
| PlaceboPlacebo matching GSK3923868 will be administered. | Drug | Placebo |
Primary outcome
Area under curve (AUC) of change from baseline (CfB) in total lower respiratory tract symptoms (LRTS) score from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
The LRTS includes cough, chest tightness, shortness of breath, wheezing, daily activity, and night time awakenings. Each symptom is assessed on a 4-point scale. The score ranges from 0 to 3, where higher points indicate more symptoms experienced and severity that restricts normal activities. Shortness of breath and wheezing will be measured on a 5-point scale and ranges from 0 to 4 in which 0 indicates no symptoms and 4 indicates symptoms at total rest and the highest level of disease severity. LRTS assessment is performed three times a day.
8 secondary outcomes
Maximal CfB in total LRTS score from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
AUC and maximal CfB in total upper respiratory tract symptoms (URTS) score from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in trough force expiratory volume (FEV1) from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
Mean percent CfB and maximum percent decline from baseline in morning and evening peak expiratory flow (PEF) from day of inoculation up to discharge
Time frame: Baseline and up to Day 15
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 22
Number of participants with clinically significant changes in vital signs
Time frame: Up to Day 22
Number of participants with clinically significant changes in electrocardiogram (ECG)
Time frame: Up to Day 22
Number of participants with clinically significant changes in clinical laboratory parameters
Time frame: Up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3923868 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) of change from baseline (CfB) in total lower respiratory tract symptoms (LRTS) score from day of inoculation up to discharge (time frame: Baseline and up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.