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The main goal of the study is to assess the effect of the administration of reference propellant [HFA-134a (1,1,1,2 - Tetrafluoroethane)] and test propellant [HFA-152a (1 - Difluoroethane)] in healthy adults on mucociliary clearance (MCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFA-152a followed by HFA-134a | Experimental |
| |
| HFA-134a followed by HFA-152a | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFA-152a | Other | HFA-152a is administered via oral inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | [AUC(0-4h)] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments. | At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. | 1 hour after inhalation on Day 7 |
| Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all following criteria apply:
Male or Female, age 30 to 55 years
Body Mass Index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening
Weight: ≥50 kg
Nonsmokers or ex-smokers for more than 6 months with a smoking history of <10 pack years
Status: healthy participants
Spirometry data.
Females must be of nonchildbearing potential, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study intervention period and at least 30 days after the last dose of study intervention.
Male participants are eligible to participate if they agree to:
All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research centre based on investigator judgment. An exception is made for Hormonal Replacement Therapy (HRT), and occasional paracetamol which may be used throughout the study.
Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Capable of using inhaler device with no physical or other issues which would impair the participant's ability to successfully use a metered dose inhaler (MDI) inhaler as instructed in this study.
Ability to comply with the protocol. Participants have capacity and no issues which would impair their ability to comply with all aspects of the protocol during the study
Exclusion Criteria:
Participants who meet any of the following exclusion criteria at screening will not be eligible to participate in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nottingham | NG11 6JS | United Kingdom |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | HFA-152a Followed by HFA-134a | Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day. |
| FG001 | HFA-134a Followed by HFA-152a | Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| ||||||||||||||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HFA-152a Followed by HFA-134a | Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | [AUC(0-4h)] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments. | Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | Hour*percentage (%) | At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7 |
|
All-cause mortality, non-serious adverse events (Non-SAEs) and SAEs were collected up to approximately 13 weeks.
Safety population included all participants who received at least one dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HFA-152a | Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2024 | Sep 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2024 | Sep 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C063006 | norflurane |
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| HFA-134a | Other | HFA-134a is administered via oral inhalation |
|
| Radiolabeled saline solution | Other | Radiolabeled saline solution is administered via oral inhalation |
|
Gamma scintigraphy was utilized to conduct assessments. |
| 1.5 hours after inhalation on Day 7 |
| Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. | 3 hours after inhalation on Day 7 |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. The AE data presented below is of frequency threshold - 0%. | Up to approximately 13 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | HFA-134a Followed by HFA-152a | Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day. |
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | HFA-134a | Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2) |
|
|
|
| Secondary | Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. | Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | % of radiolabeled particle retention | 1 hour after inhalation on Day 7 |
|
|
|
|
| Secondary | Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. | Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | % of radiolabeled particle retention | 1.5 hours after inhalation on Day 7 |
|
|
|
|
| Secondary | Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. | Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study. | Posted | Least Squares Mean | 95% Confidence Interval | % of radiolabeled particle retention | 3 hours after inhalation on Day 7 |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. The AE data presented below is of frequency threshold - 0%. | Safety population included all participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to approximately 13 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | HFA-134a | Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2) | 0 | 22 | 0 | 22 | 4 | 22 |
| Medical device site rash | General disorders | MedDRA 26.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |